Grade 2 or greater peripheral neuropathy
Grade 2 or greater peripheral neuropathy
Peripheral neuropathy of severity greater than grade 1
Peripheral neuropathy greater than or equal to Grade 2
Patients with greater than or equal to grade 2 peripheral neuropathy or active herpes infection
Patients with grade 2 or greater neuropathy
Grade 2 or greater neuropathy
Current Grade greater than (>) 1 peripheral neuropathy by clinical examination
Peripheral neuropathy grade 2 or greater
Participants with baseline peripheral neuropathy greater than grade 2
Patients with greater than or equal to grade 2 peripheral neuropathy at baseline
Grade 2 or greater neuropathy
Have grade 2 or greater neuropathy at the time of screening
Uncontrolled neuropathy grade 2 or greater, regardless of cause
No prior evidence of grade 3 or greater ototoxicity or neuropathy
Patients with peripheral neuropathy greater than grade II
Has history of Grade 2 or greater peripheral neuropathy during the 3 months prior to enrollment.
Patient has peripheral neuropathy of Grade 3 or greater intensity, or painful Grade 2, as defined by the NCI CTC.
Patients with grade 2 or greater peripheral neuropathy.
Grade II or greater neuropathy at baseline
Subjects with grade 2 or greater neuropathy
Peripheral neuropathy of severity greater than grade 1
Greater than grade 1 peripheral neuropathy at baseline
Grade 2 or greater neuropathy
Peripheral neuropathy grade 2 or greater
Grade 2 or greater neuropathy [Applies to Phase 1]. Grade 3 or greater neuropathy [Applies to Phase 2].
Equal to or greater than grade 2 ataxia, cranial or peripheral neuropathy
Grade 2 or greater neuropathy
Patients must not have grade 2 or greater peripheral neuropathy
Uncontrolled neuropathy grade 2 or greater regardless of cause.
Peripheral neuropathy- grade 2 or greater
Peripheral neuropathy grade 2 or greater
Patients with grade 2 peripheral neuropathy or greater are excluded
Equal to or greater than grade 2 ataxia, cranial or peripheral neuropathy
Patients with grade II or greater peripheral neuropathy will be excluded from study
Patients with greater than or equal to grade 2 peripheral neuropathy at baseline
Peripheral neuropathy greater than Grade 1
No peripheral neuropathy greater than grade 1, due to any cause
Greater than or equal to Grade-2 neuropathy
Peripheral neuropathy of grade 2 or greater
have persistent Grade 2 or greater toxicities from any cause (except alopecia or peripheral neuropathy).
Severe neuropathy greater than or equal to grade 2
Peripheral neuropathy greater than grade 1
Grade 3 or greater edema (eg, peripheral, pulmonary)
Patients with greater than 2 screening peripheral neuropathy
Current peripheral neuropathy of NCI-CTC, version 4.0 Grade 3 or greater
Grade 2 or greater peripheral neuropathy
Peripheral neuropathy that is greater or equal to Grade 2
Has peripheral neuropathy that is greater or equal to Grade 2
The participant has any Grade 2 (or greater) peripheral neuropathy.
No grade 2 or greater peripheral neuropathy.
Peripheral neuropathy greater than or equal to grade 2.
Peripheral neuropathy greater than grade 1
Peripheral neuropathy greater than grade 1
Any serious and/or unstable pre-existing medical, psychiatric, or other existing condition that would prevent compliance with the trial or consent process
Pre-existing Grade 2 or higher chronic diarrhoea
Pre-existing neuropathy greater than or equal to grade 2
Subjects with pre-existing grade II peripheral neuropathy
G>1 pre-existing peripheral neuropathy
Clinically significant peripheral neuropathy at the time of study entry. Patients with pre-existing peripheral neuropathy will be allowed to receive single agent DKN-01
Pre-existing peripheral neuropathy Grade 2 or higher
Pre-existing neuropathy Grade 2 or higher
Severe pre-existing ototoxicity or neuropathy that would, in the opinion of the investigator, preclude the use of cisplatin chemotherapy
Serious pre-existing medical conditions as follows:
< Grade 2 pre-existing peripheral neuropathy per CTCAE
Patients with pre-existing grade >= 3 peripheral neuropathy
Patients with pre-existing peripheral neuropathy that would limit treatment with taxanes and platinum agents
Has pre-existing brain or bone metastatic lesions.
Skin condition\r\n* Patients with pre-existing grade 1 or higher ulcerations, fistulas, mucosal lesions, or skin barrier breakdown
Exclude patients with pre-existing neuropathy grade 2 or higher
Pre-existing and ongoing radiation-related grade 3 bowel or bladder toxicity
Patients must have < grade 2 pre-existing peripheral neuropathy (per CTCAE)
History of pre-existing immunodeficiency disorder, autoimmune condition, or chronic infection
Pre-existing peripheral neuropathy of grade II or higher
Pre-existing > grade 2 peripheral sensory neuropathy
Pre-existing sensory neuropathy of grade >= 2
Pre-existing grade 3 or 4 neuropathy
Pre-existing (active or severe) neurologic disorders (e.g. pre-existing seizure disorder)
Pre-existing viral hepatitis
Pre-existing neuropathy greater than grade 1
Patients with pre-existing retinopathy
Pre-existing peripheral neuropathy of severity grade >= 2 (limiting instrumental activities of daily living)
Pre-existing neuropathy of >= grade 2
Pre-existing grade >= 2 peripheral sensory neuropathy
Pre-existing vocal cord paralysis
Neurological assessment for pre-existing peripheral neuropathy
Patients with pre-existing grade 2 or greater peripheral neuropathy, defined as sensory alteration or paresthesia (including tingling), interfering with function
MDS evolving from a pre-existing myeloproliferative neoplasm (MPN)
Pre-existing peripheral neuropathy CTCAE grade 2 or worse
Subjects with existing periorbital edema
Pre-existing peripheral neuropathy grade ?= 2 at registration
Pre-existing grade 2 or greater neuropathy
Patients with pre-existing grade 2 or higher neuropathy or other serious neurologic toxicity that would significantly increase risk of complications from bortezomib therapy are excluded
Pre-existing peripheral neuropathy > grade 2 with pain (CTC version 4.0).
Any known pre-existing autoimmune disorder
Pre-existing nephritic syndrome
Pre-existing grade >= 1 peripheral neuropathy
Pre-existing neuropathy of at least Grade 2
Has a pre-existing condition that is contraindicated including
Less than Grade 2 pre-existing peripheral neuropathy
Pre-existing neuropathy from any cause in excess of Grade 1.
Pre-existing peripheral neuropathy >= Common Terminology Criteria (CTC) grade 2 for those patients who received prior paclitaxel
Patients must have recovered from all reversible toxicities related to prior therapy before beginning protocol treatment, and may not have any pre-existing treatment-related toxicities greater than grade 2; patients must have < grade 2 pre-existing peripheral neuropathy
Patients must have < Grade 2 or pre-existing neuropathy (per CTCAE).
Pre-existing Grade greater than (>) 1 neuropathy
Pre-existing cardiac conditions
Side effects from prior treatment have not resolved to =< grade 1 (or baseline due to previously administered agent/pre-existing conditions)
Pre-existing peripheral neuropathy (grade I or higher)
Participant has received treatment with cytarabine for a pre-existing myeloid disorder.
Patients with Grade 2 or greater pre-existing neurologic abnormalities (CTCAE version 4.0), including Grade 2 or greater peripheral neuropathy caused by previous treatments.
Subjects with pre-existing grade 3 or 4 neuropathy; any peripheral neuropathy must recover to grade =< 1 before enrollment
Pre-existing grade 3 or 4 sensory neuropathy
Pre-existing neuropathy greater than grade 1
Pre-existing neuropathy greater than grade 1.
Pre-existing neuropathy grade III or greater
Pre-existing neuropathy from any cause in excess of Grade 1
Patients with pre-existing maculopathy or retinopathy of the eye
Pre-existing peripheral neuropathy >= grade 2
Existing autoimmune cytopenia
History of pre-existing post-traumatic stress disorder (PTSD)
Have serious pre-existing medical conditions.
Have serious pre-existing medical conditions (at the discretion of the investigator).
>= grade 2 pre-existing peripheral neuropathy (per CTCAEv4)
Pre-existing cancers and/or metastatic disease to the adrenal glands
Pre-existing peripheral neuropathy grade >= 2
Pre-existing neuropathy or severe fluid retention
Pre-existing peripheral neuropathy greater than CTCAE Grade 2.
Pre-existing >= grade 2 peripheral neuropathy
Patients with pre-existing neurologic toxicity > grade 1 (as per CTCAE version 3.0) are not eligible for participation in cohort A; patients screened for participation in cohort B with pre-existing neurologic toxicity > grade 2 (as per CTCAE, version 3.0) are not eligible, unless pre-existing neurologic toxicity is documented in detail and patient's participation in the trial has been approved by the neuro-oncology team at participating institutions
Pre-existing coagulopathy
Patient has pre-existing peripheral neuropathy Grade >1
Subject has MDS evolving from a pre-existing myeloproliferative neoplasm (MPN).
Pre-existing symmetric peripheral painful neuropathy
Pre-existing LE prior to their BC diagnosis
Existing CVD
Patients with any pre-existing medical conditions that would be a contraindication to exercise
EXCLUSION - STUDY 1: Pre-existing neuropathy including CIPN from prior neurotoxic chemotherapy
History of pre-existing neuropathic pain conditions
Pre-existing neutropenia or neutrophil qualitative or quantitative disorder
Pre-existing cytopenia or bone marrow failure syndrome
Self-reported or documented history of pre-existing peripheral neuropathy due to diabetes, human immunodeficiency virus (HIV), or other conditions
Pre-existing active or untreated immunodeficiency disorder and/or chronic use of systemic steroids
Patients with pre-existing medical conditions that would be a barrier to exercise
Other identified causes of painful paresthesias existing prior to chemotherapy (e.g., radiation or malignant plexopathy, lumbar or cervical radiculopathy, pre-existing peripheral neuropathy of another etiology: e.g., carpal tunnel syndrome, B12 deficiency, acquired immune deficiency syndrome [AIDS], monoclonal gammopathy, diabetes, heavy metal poisoning amyloidosis, syphilis, hyperthyroidism or hypothyroidism, inherited neuropathy, etc.) that might be responsible for the patient’s current neuropathic symptoms
SCREENING PHASE: Pre-existing peripheral neuropathy within 28 days of screening consent
INTERVENTION PHASE: Pre-existing peripheral neuropathy within 28 days of screening consent
Pre-existing grade 2 or greater neuropathy
History of pre-existing peripheral neuropathy prior to chemotherapy, including alcoholism, vitamin B deficiency, diabetes, human immunodeficiency virus (HIV), congenital neuropathy, toxic neuropathy
Pre-existing neuropathy, neuropathic pain, or nerve injury;
Pre-existing alopecia
Patient is using a pre-existing feeding tube for nutritional support at the time of study entry
Subject is using a pre-existing feeding tube for nutritional support at study entry.
Have pre-existing peripheral neuropathy from other medical conditions or due to cancer
Self-reported or documented history of pre-existing peripheral neuropathy prior to initiation of taxane chemotherapy
Pre-existing sensory neuropathy > grade 1
>= Grade 2 peripheral sensory neuropathy (CTCAE, v. 4.0)
Patients with > grade 2 sensory peripheral neuropathy.
Preexisting sensory neuropathy Grade ? 2
Peripheral neuropathy >= grade 3 sensory neuropathy or >= grade 2 sensory neuropathy with pain within 14 days of registration; prior neuropathy of this severity improved due to medical management such as gabapentin are potentially eligible
Sensory/peripheral neuropathy.
Grade 2 sensory or Grade 1 painful peripheral neuropathy
Patients must not have > grade sensory neuropathy
No baseline peripheral sensory neuropathy >= grade 2
Patients with evidence of >= grade 2 peripheral sensory neuropathy
No >= grade 2 sensory peripheral neuropathy
Peripheral sensory neuropathy at the thumbs bilaterally that interferes with function and/or activities of daily living
Patients must not have grade 2 or greater peripheral sensory neuropathy
RANDOMIZED PHASE II (ARMS K AND L): Patients must not have grade 2 or greater peripheral sensory neuropathy
Sensory peripheral neuropathy >= grade 2
Subject has known peripheral sensory neuropathy > Grade 1 unless the absence of deep tendon reflexes is the sole neurological abnormality.
Baseline peripheral sensory neuropathy ? grade 2
Baseline of grade 2 or worse peripheral sensory neuropathy
Participant with sensory peripheral neuropathy of ? Grade 2 at baseline, unable to swallow medication, or participants with prior history of seizure within the prior 12 months.
Preexisting sensory grade 3 neuropathy
Preexisting sensory grade >= 2 neuropathy
Current peripheral sensory neuropathy > grade 1
Existence of peripheral sensory neuropathy >= grade 2 (from any cause)
Patients with grade 2 sensory neuropathy at baseline
Patient has >= grade 3 peripheral sensory neuropathy or >= grade 2 painful sensory neuropathy within 14 days before enrollment; (NOTE: patient with peripheral neuropathy [PN] that was previously this severe but is currently improved due to ongoing therapy [e.g., gabapentin or amitriptyline] may be eligible)
Grade >= 2 sensory neuropathy at the time of enrollment
No peripheral or sensory neuropathy > grade 1 at study entry
Preexisting sensory grade >= 2 neuropathy
?Grade 2 sensory neuropathy at baseline
Sensory peripheral neuropathy greater than or equal to (>/=) Grade 2
Evidence of sensory and/or peripheral neuropathy > grade 1
Grade ? 2 sensory neuropathy
Sensory peripheral neuropathy greater than or equal to (>/=) Grade 2
Grade ? 2 sensory neuropathy
Evidence of grade 2 or greater sensory and/or peripheral neuropathy
No evidence of peripheral or sensory neuropathy
Patients with > grade 2 sensory peripheral neuropathy
Patients with ? grade 2 sensory peripheral neuropathy
No current peripheral neuropathy > grade 2 at time of randomization
Peripheral neuropathy Grade ? 2
Peripheral neuropathy of any etiology that exceeds grade 1
Patients must not have baseline peripheral neuropathy that exceeds grade 1
=< grade 2 peripheral neuropathy; patients with grade 1 peripheral neuropathy with pain will be excluded
=< grade 2 peripheral neuropathy
Peripheral neuropathy >= 2
Grade >= 2 peripheral neuropathy
Patients with a baseline peripheral neuropathy >= grade 2 will not be eligible
Patients with preexisting grade II peripheral neuropathy
Peripheral neuropathy ? Grade 2.
Grade >= 2 peripheral neuropathy at the present time
Peripheral neuropathy of Grade 2 within 3 weeks prior to the first study therapy
Peripheral neuropathy ?grade 3.
Peripheral neuropathy >= grade 2 at screening
Peripheral neuropathy > Grade 2 despite supportive therapy.
Participants with >= grade 2 peripheral neuropathy
Baseline peripheral neuropathy of severity > grade 1
Presence of >= grade 2 peripheral neuropathy
Peripheral neuropathy >= grade 2
Presence of peripheral neuropathy > grade 1
Peripheral neuropathy =< grade 1 at the time of registration
Presence of > grade 1 peripheral neuropathy
Peripheral neuropathy >Grade 2
Patients must not have peripheral neuropathy ? grade 2
Grade >= 2 peripheral neuropathy
Peripheral neuropathy > grade 1
Peripheral neuropathy > CTCAE grade 1
Clinically significant (>= grade 2) peripheral neuropathy at the time of study entry
Peripheral neuropathy grade > 1
Has greater than Grade 1 peripheral sensory neuropathy or > Grade 1 peripheral motor neuropathy graded according to the Modified (\Balis\) Pediatric Scale of Peripheral Neuropathies.
CTCAE grade >= 2 peripheral neuropathy is NOT permitted
Effects of any other prior therapies not reverted to ? Grade 1 (or ? Grade 2 for alopecia and peripheral neuropathy).
Active >= grade 3 peripheral neuropathy
Peripheral neuropathy > grade 1
Patients with > grade 1 peripheral neuropathy
Peripheral neuropathy grade 1 or less.
No peripheral neuropathy
Baseline grade II peripheral neuropathy
Current peripheral neuropathy >= grade 2
Peripheral neuropathy >= grade 2 at screening
Patients with a peripheral neuropathy > grade 1
Peripheral neuropathy >= grade 2
Baseline grade II peripheral neuropathy
Patients with a peripheral neuropathy > grade 1
ENTRECTINIB EXCLUSION CRITERIA: Peripheral neuropathy >= grade 2
Grade >= 2 peripheral neuropathy at baseline (within 21 days prior to cycle 1 day 1)
Patients with peripheral neuropathy of > grade 1
No peripheral neuropathy >= grade 2 at baseline
Peripheral neuropathy, if present, should be =< grade 1
Peripheral neuropathy > grade 1 if due to brentuximab vedotin or any peripheral neuropathy > grade 2
Peripheral neuropathy grade 0-2
Patients with preexisting peripheral neuropathy >= grade 2 are ineligible
Patients with grade >= 2 peripheral neuropathy
For the bortezomib arm of the study, patients with grade >= 2 peripheral neuropathy
Peripheral neuropathy > grade 1
Peripheral neuropathy >= grade 1
Has > Grade 1 peripheral sensory neuropathy or > Grade 1 peripheral motor neuropathy graded according to the Modified (\Balis\) Pediatric Scale of Peripheral Neuropathies
CTCAE v4 Grade ?2 peripheral neuropathy
Grade >= 2 peripheral neuropathy
Preexisting peripheral neuropathy is not allowed from any cause
Grade >= 2 peripheral neuropathy
>= grade 2 peripheral neuropathy
Peripheral neuropathy >= grade 2 despite supportive therapy
Patients with existing grade 3 or 4 peripheral neuropathy
Peripheral neuropathy >= grade 2 at baseline OR peripheral neuropathy >= grade I with neuropathic pain
Patients with grade 3/4 peripheral neuropathy
Patients who have baseline peripheral neuropathy >= grade 2 are not eligible
Grade > 2 peripheral neuropathy at baseline (within 14 days prior to cycle 1 day 1)
Subject has >= grade 2 peripheral neuropathy
Peripheral neuropathy >= grade 2
Patients with > grade 1 peripheral sensory neuropathy or > grade 1 peripheral motor neuropathy graded according to the Modified (“Balis”) Pediatric Scale of Peripheral Neuropathies are not eligible
Peripheral neuropathy >= grade 2
Peripheral neuropathy >= grade 2
Peripheral neuropathy =< grade 1
>= grade 2 peripheral neuropathy
>= grade 2 peripheral neuropathy within 14 days before beginning maintenance therapy
Patients with >= grade 2 peripheral neuropathy
Patients must not have peripheral neuropathy >= grade 2
Patients with peripheral neuropathy > grade 2 regardless of etiology
Has peripheral neuropathy ? Grade 2.
Peripheral neuropathy =< grade 1
Has peripheral neuropathy ? Grade 2
Subjects with baseline peripheral neuropathy that exceeds grade 1
Significant symptoms (grade >= 2) peripheral neuropathy
Peripheral neuropathy ? Grade 3 or ? Grade 2 with pain within 2 weeks prior to first dose
Peripheral neuropathy ? Grade 2
Peripheral neuropathy ? Grade 2.
Has peripheral neuropathy ? Grade 2
Current Grade >1 peripheral neuropathy
Grade ? 2 peripheral neuropathy
Peripheral neuropathy < grade 2
Grade >= 2 peripheral neuropathy
Current Grade >1 peripheral neuropathy from any cause
Patients must not have peripheral neuropathy > grade 2
Peripheral neuropathy exclusions
? Grade 2 peripheral neuropathy
Baseline peripheral neuropathy/paresthesia grade >= 1
Serious peripheral neuropathy.
Peripheral neuropathy ? Grade 2.
Previous diagnosis of diabetic neuropathy or peripheral neuropathy from any cause
Participants who have more than grade 1 peripheral neuropathy
Peripheral neuropathy >= grade 2
Peripheral neuropathy < grade 2
Clinically significant peripheral neuropathy
Has baseline peripheral neuropathy/paresthesia grade ? 1.
Evidence of peripheral neuropathy of Grade >2.
Subject has peripheral neuropathy ? grade 2.
Peripheral neuropathy >= grade 1
Grade 3 or above peripheral neuropathy
Peripheral neuropathy: must be =< grade 1
Grade > 2 peripheral neuropathy at baseline
Grade >= 2 peripheral neuropathy within 14 days prior to cycle 1 day 1
Patients with existing peripheral neuropathy grade > 2
Peripheral neuropathy =< grade 1 at the time of registration
Grade >= 2 peripheral neuropathy within 14 days prior to initiation of therapy
Subject has peripheral neuropathy >= grade 2.
Presence of peripheral neuropathy ? CTCAE Grade 2
Peripheral neuropathy ? Grade 2 despite supportive therapy
Has baseline peripheral neuropathy/paresthesia
COHORT II: Patients must not have >= grade 2 peripheral neuropathy
Peripheral neuropathy > Grade 2.
Peripheral neuropathy >= grade 2 at baseline OR peripheral neuropathy >= grade I with neuropathic pain
Peripheral neuropathy: must be =< grade 1
Grade 2 or more peripheral neuropathy
Peripheral neuropathy of grade >=3. Patients with painful grade 2 neuropathy are also excluded
Peripheral neuropathy ? Grade 2
Peripheral neuropathy >= grade 3
No ? grade 2 peripheral neuropathy.
CTCAE version 4.03 > grade 3 peripheral neuropathy
Peripheral neuropathy =< grade 1
Peripheral neuropathy >= grade (Gr) II
Peripheral neuropathy =< grade 1
Peripheral neuropathy >/= Grade 2 (NCI-CTC Version 3.0)
Grade 3 peripheral neuropathy
Patients with peripheral neuropathy of grade >= 3; patients with painful grade 2 neuropathy are also excluded
Peripheral neuropathy
Peripheral neuropathy > grade 2
> grade 2 peripheral neuropathy at baseline
Presence of ? Grade 2 peripheral neuropathy
Peripheral neuropathy ? Grade 3.
Presence of clinically significant non-hematological toxicity of prior chemotherapy that has not resolved to ? Grade 1 as determined by CTCAE v 4.0, with the exception of alopecia and peripheral neuropathy. Note: Peripheral neuropathy > Grade 2 plus pain, or Grade 3 or Grade 4 are excluded.
Presence of > Grade 1 peripheral neuropathy
Peripheral neuropathy CTCAE Grade ?2
Peripheral neuropathy ? Grade 2
Patients with peripheral neuropathy > 2
Baseline peripheral neuropathy ? grade 2.
Peripheral neuropathy ? grade 2.
Grade >= 2 peripheral neuropathy
Patients with grade >= 2 peripheral neuropathy will not be permitted on study
Patients with preexisting peripheral neuropathy grade >= 2 will not be eligible
Evidence of peripheral neuropathy of Grade > 2
Subjects with > grade 1 peripheral neuropathy
Patients with > grade 2 neuropathy according to the Modified (“Balis”) Pediatric Scale of Peripheral Neuropathies will be excluded except in cases in which neuropathy is secondary to prior surgery
Peripheral neuropathy Grade >/=2
Subjects with preexisting Grade 3 or 4 neuropathy. Any peripheral neuropathy must recover to Grade less than or equal to 2 before enrollment
Presence of peripheral neuropathy
Subjects with Grade >2 peripheral neuropathy
Peripheral neuropathy at study entry
Peripheral neuropathy CTCAE v4.03 Grade ? 3
Patients with peripheral neuropathy >= grade 2
Peripheral neuropathy ? CTCAE Grade 2 at baseline.
Patients who have grade >= 2 peripheral neuropathy
Preexisting grade >= 2 peripheral neuropathy
Patients with peripheral neuropathy >= grade 2 are not permitted unless discussed with the principal investigator and only in unique circumstances (i.e. unilateral neuropathy due to trauma)
Ongoing Grade 3 or Grade 4 peripheral neuropathy, or Grade 2 peripheral neuropathy with pain despite appropriate interventions, within 28 days prior to first dose of study treatment.
No grade >= 2 peripheral neuropathy
Grade >=2 peripheral neuropathy
Part 2 only: Patients with >= grade 2 peripheral neuropathy.
Peripheral neuropathy ?Grade 2.
>= grade 2 peripheral neuropathy
Peripheral neuropathy
Patients with a >= grade 2 peripheral neuropathy
Current Grade >1 peripheral neuropathy
History of peripheral neuropathy; (note: this does not apply to Cohort 3)
Grade >=2 peripheral neuropathy
Patients with peripheral neuropathy >= grade 2
Grade ?2 peripheral neuropathy at baseline (within 14 days prior to cycle 1 day 1).
Peripheral neuropathy >= grade 2
Patient has > Grade 2 painful neuropathy or peripheral neuropathy
Peripheral neuropathy ? Grade 2
Patients with peripheral neuropathy > grade 1 will be excluded from study participation
History of peripheral neuropathy of ?grade 2
Patients with symptomatic peripheral neuropathy> Grade 1.
Peripheral neuropathy > grade 1 (NCI-CTC).
Peripheral neuropathy of > grade 2 severity.
Peripheral neuropathy ? CTCAE grade 2
Peripheral neuropathy with grade =< 1
Clinically significant (>= grade 2) peripheral neuropathy at the time of study entry
Peripheral neuropathy >= grade 1
Grade >= 2 peripheral neuropathy
Patients must not have a history of peripheral neuropathy (regardless of cause)
Any peripheral neuropathy >= grade 3
Patients with known, previously diagnosed peripheral neuropathy from causes other than chemotherapy
Grade III or IV upper extremity peripheral neuropathy
Self-report of >= 4 on the Peripheral Neuropathy Question
Patients with known, previously diagnosed peripheral neuropathy from causes other than chemotherapy.
History of peripheral neuropathy prior to receiving neurotoxic chemotherapy
Pain or symptoms of peripheral neuropathy of > 3 month's duration attributed to chemotherapy-induced peripheral neuropathy
Previous diagnosis of diabetic neuropathy or peripheral neuropathy from any cause
No >= grade 2 peripheral neuropathy
Peripheral neuropathy ? grade 2
Persisting toxicity related to prior therapy (NCI CTCAE v. 4.03 Grade > 1); however, alopecia, sensory neuropathy Grade ? 2, or other Grade ? 2 not constituting a safety risk based on Investigator's judgment are acceptable.
Resolution of all chemotherapy-related or radiation-related toxicities to grade 1 severity or lower, except for stable sensory neuropathy (=< grade 2 allowed) and alopecia (of any grade)
Resolution of all chemotherapy-related or radiation-related toxicities to grade 1 severity or lower, except for stable sensory neuropathy (=< grade 2) and alopecia
Received prior chemotherapy, an immune checkpoint inhibitor, or radiation therapy within 2 weeks prior to study registration or who has not recovered (i.e., ? Grade 1 or at baseline) from adverse events from previously administered agents. NOTE: Subjects with alopecia, grade ? 2 sensory neuropathy or other grade ? 2 AEs not constituting a safety risk based on investigator judgement are an exception to this criterion and can still be considered for the study.
Persisting toxicity related to prior therapy that has not reduced to grade 1 (National Cancer Institute Common Toxicity Criteria for Adverse Events [NCI CTCAE] version 5.0); however, alopecia and sensory neuropathy grade =< 2 is acceptable.
Persisting toxicity related to prior therapy (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v]. 4.03 grade > 1); however, alopecia, sensory neuropathy grade =< 2, or other grade =< 2 not constituting a safety risk based on investigator's judgement are acceptable
Persisting toxicity (except alopecia and vitiligo) related to prior oncologic therapy grade > 1 NCI-CTCAE v4.03, however, sensory neuropathy grade =< 2 is acceptable.
Patients must have recovered from adverse events due to prior treatment to ? grade 1, except for alopecia and sensory neuropathy ? grade 2
All adverse events Grade > 1 related to prior therapies (chemotherapy, radiotherapy, and/or surgery) must be resolved to grade 1 or baseline, except for alopecia and sensory neuropathy Grade ? 2, or other Grade ? 2 not constituting a safety risk based on investigator's judgment, are acceptable.
Persisting toxicity related to prior therapy of grade > 1 NCI-CTCAE v 4.03; however, alopecia and sensory neuropathy grade =< 2 is acceptable.
Patients must have recovered from adverse events attributable to previous treatment to =< grade 1, except for alopecia and sensory neuropathy =< grade 2
Persisting toxicity related to prior therapy (NCI CTCAE v. 4.03 grade > 2); however, alopecia, sensory neuropathy grade ? 2, or other grade ? 2 not constituting a safety risk based on investigator’s judgment are acceptable
All adverse events grade > 1 related to prior therapies (chemotherapy, radiotherapy, and/or surgery) must be resolved to grade 1 or baseline, except for alopecia and sensory neuropathy grade =< 2, or other grade =< 2 not constituting a safety risk based on investigator’s judgment, are acceptable
Persisting toxicity from prior therapy (National Cancer Institute [NCI] CTCAE v4.03 grade >1); however alopecia or other grade =< 2 adverse events (AEs) not constituting a safety risk, based on investigator’s judgement, are acceptable
Persisting toxicity related to prior therapy (Common Terminology Criteria for Adverse Events [CTCAE] > grade 1); however, alopecia, sensory neuropathy =< grade 2, or other =< grade 2 not constituting a safety risk based on the investigator’s judgment are acceptable
Have resolution of all previous treatment-related toxicities to Grade 1 severity or lower, except for stable sensory neuropathy (less than or equal to Grade 2) or alopecia. If subject received major surgery or radiation therapy of > 30 Gy, must have recovered from the toxicity and/or complications from the intervention.
Persisting toxicity related to prior therapy (NCI CTCAE v. 4.03 Grade > 1); however, alopecia, sensory neuropathy grade =< 2, or other grade =< 2 not constituting a safety risk based on investigator’s judgment are acceptable.
Persisting toxicity related to prior therapy (NCI CTCAE v. 4.03 grade > 1); however, alopecia, sensory neuropathy grade ? 2, or other grade ? 2 not constituting a safety risk based on investigator’s judgment are acceptable
Persisting toxicity related to prior therapy (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v.] 4.03 grade > 1); however, alopecia, sensory neuropathy grade =< 2, grade 2 anemia, or other grade =< 2 not constituting a safety risk based on investigator’s judgment are acceptable
Persisting toxicity related to prior therapy of grade > 1 NCI-CTCAE v 4.03; however, alopecia and sensory neuropathy grade =< 2 is acceptable
Persisting toxicity related to prior therapy (NCI CTCAE v. 4.03 grade > 1); however, alopecia, sensory neuropathy grade =< 2, or other grade =< 2 not constituting a safety risk based on investigator’s judgment are acceptable
Persisting toxicity related to prior therapy of grade > 1 NCI-CTCAE v 4.03; however, alopecia and sensory neuropathy grade =< 2 is acceptable
Persisting toxicity related to prior therapy (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 4.03 [v4.03] grade > 1); however alopecia, sensory neuropathy grade =< 2, or other grade =< 2 adverse events (AEs) not constituting a safety risk based on investigator's judgment are acceptable
Persisting toxicity related to prior therapy of grade > 1 NCI-CTCAE v 4.03; however, alopecia and sensory neuropathy grade =< 2 is acceptable
Persisting toxicity related to prior therapy that has not reduced to grade 1 (National Cancer Institute Common Toxicity Criteria for Adverse Events [NCI CTCAE] version 4.03); however, alopecia and sensory neuropathy grade =< 2 is acceptable
Recovered from any previous therapy related toxicity to =< grade 1 or baseline at study entry (except for stable sensory neuropathy =< grade 2 and alopecia)
Persisting toxicity related to prior therapy of grade > 1 NCI-CTCAE v 4.03; however, alopecia and sensory neuropathy grade =< 2 is acceptable
Persistent grade > 1 clinically significant toxicities related to prior antineoplastic therapies (except for alopecia); stable sensory neuropathy ? grade 1 NCI-CTCAE v. 4.0 is allowed.
Persisting effects of any previous or ongoing treatment ? grade 1 that might compromise delivery of study treatment or assessment of adverse events (except alopecia or neuropathy ? grade 2 without pain)
Patients must have recovered to =< grade 1 adverse events or to =< grade 2 alopecia and sensory neuropathy due to prior treatment
Patients must have recovered from adverse events attributable to previous treatment to =< grade 1, except for alopecia and sensory neuropathy =< grade 2
Persisting toxicity related to prior therapy Grade > 1 NCI-CTCAE v 4.0; however, sensory neuropathy Grade <= 2 is acceptable 14. Pregnancy or lactation
Resolution of grade 2 and above toxicities of most recent therapy except for stable sensory neuropathy (=< grade 2) and alopecia
Persisting ?Grade 2 CTCAE toxicity (except alopecia and Grade 2 peripheral neuropathy) from previous anti-cancer treatment(s)
Patients who have not recovered from adverse events to grade 1 severity or lower due to agents administered more than 2 weeks earlier than registration, are not eligible, except for stable sensory neuropathy (=< grade 2) and alopecia
Persisting toxicity related to prior therapy of grade > 1 NCI-CTCAE v 4.03; however, alopecia, sensory neuropathy grade =< 2 or other grade =< 2 adverse events (AEs) not constituting a safety risk based on investigator's judgment are acceptable
Recovery to ? Grade 1 or baseline of any toxicities, except for stable sensory neuropathy ? Grade 2 and alopecia
Participants who have had endocrine, chemotherapy, and/or biologic therapy < 14 days prior to entering the study or those who have not recovered from any prior treatment-related toxicities (must recover to no more than grade 1; alopecia, sensory neuropathy grade =< 2, or other grade =< 2 toxicity not constituting a safety risk based on investigator’s judgment are acceptable)
Persisting toxicity related to prior therapy of NCI CTCAE grade >1 severity. Sensory neuropathy of grade ?2 is acceptable.
Have resolution of all previous treatment-related toxicities to Grade 1 severity or lower, except for stable sensory neuropathy (less than or equal to Grade 2) or alopecia. If subject received major surgery or radiation therapy of > 30 Gy, must have recovered from the toxicity and/or complications from the intervention.
Persisting toxicity related to prior therapy (Grade >1 NCI CTCAE v4.0); however, alopecia, sensory neuropathy (Grade 2 or less), or other (Grade 2 or less) adverse events not constituting a safety risk based on the investigator's judgement are acceptable.
Patients must have recovered from adverse events attributable to previous treatment to =< grade 1, except for alopecia and sensory neuropathy =< grade 2
Resolution of all chemotherapy-related or radiation-related toxicities to Grade 1 severity or lower, except for stable sensory neuropathy (<= Grade 2) and alopecia.
Recovered from any previous therapy related toxicity to <= Grade 1 at study entry (except for stable sensory neuropathy <= Grade 2 and alopecia)
Chemotherapy-related or radiation-related toxicities that have not resolved to grade 1 severity or lower, except for stable sensory neuropathy (=< grade 2) and alopecia
Persisting toxicity related to prior therapy (NCI CTCAE v. 4.03 grade > 1); however, alopecia, sensory neuropathy grade =< 2, or other grade =< 2 not constituting a safety risk based on investigator’s judgment are acceptable
Persisting toxicity related to prior therapy of grade > 1 NCI-CTCAE v 4.03; however, alopecia and sensory neuropathy grade =< 2, or other grade =< 2 not constituting a safety risk based on investigator’s judgment, are acceptable
Ongoing sensory or motor neuropathy Grade ?2.
No grade >= 2 peripheral motor or sensory neuropathy
Neuropathy (sensory and motor) =< CTCAE v 3.0 grade 1
Neuropathy (sensory and motor) less than or equal to CTCAE grade 1
Patients must have < grade 2 neuropathy (sensory/motor) within 7 days prior to registration
Subject has preexisting sensory or motor neuropathy Grade ? 2 at baseline
Participants with grade >= 3 peripheral motor or sensory neuropathy
Neuropathy (sensory and motor) NCI CTCAE grade =< 2
Neuropathy (sensory and motor) less than or equal to CTCAE v4.0, grade 1
Patients who have pre-existing motor or sensory neuropathy of a severity ? grade 1 by CTCAE v4.0 criteria
Nervous system disorder (paresthesias, peripheral motor neuropathy, or peripheral sensory neuropathy) ? Grade 2, per the CTCAE v4.0.
Grade ? 3 sensory or motor neuropathy.
Has not recovered from adverse reactions to prior myeloma treatment or procedures (chemotherapy, immunotherapy, radiation therapy) to NCI CTCAE less than or equal to (<=) Grade 1 or baseline, except for sensory or motor neuropathy which should have recovered to <=Grade 2 or baseline.
Sensory or motor neuropathy ? grade 2
Preexisting motor neuropathy Grade ? 2
Neuropathy (sensory and motor) less than or equal to CTCAE v4.03 grade 1
Sensory or motor neuropathy >= grade 2
Ongoing sensory or motor neuropathy Grade 2 or higher.
Sensory or motor neuropathy >= Grade 2.
Neuropathy (sensory and motor) =< to CTCAE grade 1
Patients with symptomatic peripheral motor or sensory neuropathy >= grade 2 at baseline will receive radiation therapy alone
Neuropathy (sensory and motor) less than or equal to grade 1 per Common Toxicity Criteria (CTC) version 4
Grade 3 sensory neuropathy or motor neuropathy with pain
Sensory/motor neuropathy >= grade 2
Sensory/motor neuropathy >= grade 2
Patients with any of the following adverse events at the time of enrollment are not eligible:\r\n* Grade ? 2 motor, sensory or peripheral neuropathy\r\n* Grade ? 3 hyponatremia (serum sodium [Na] ? 130 mmol/L)
Participant must have either no neuropathy (sensory and motor) or neuropathy less than or equal to grade 1
Patients with persistent grade 2 or higher peripheral sensory or motor neuropathy of any cause
Sensory or motor peripheral neuropathy >= grade 2
Sensory or motor neuropathy >= grade 2
Subject has preexisting sensory or motor neuropathy Grade ? 2 at baseline
Pre-existing >= grade 2 sensory or motor peripheral neurotoxicity
Motor peripheral neuropathy = grade 0 (per CTCAE v. 4.0)
Patients must not have a pre-existing > grade 1 motor or sensory neuropathy
PHASE II: Patients must not have a pre-existing > grade 1 motor or sensory neuropathy
Neuropathy (sensory and motor) =< grade 1
Neuropathy (sensory and motor) less than or equal to CTEP CTCAE version 4.0, grade 1
Pre-existing peripheral motor or sensory neuropathy >= grade 2
Neuropathy (sensory and motor) less than or equal to Grade 1.
Preexisting sensory neuropathy Grade ? 2 or motor neuropathy Grade ? 2
Motor neuropathy considered of autoimmune origin
Sensory or motor peripheral neuropathy
Neuropathy (sensory and motor) less than or equal to grade 1
Neuropathy (sensory and motor) less than or equal to grade 1
Preexisting sensory and/or motor neuropathy Grade ? 2
History of severe motor or sensory neuropathy, or any other autoimmune disorder which is deemed to be significant
CTC Grade 1 or greater neuropathy (motor or sensory) from comorbidity other than prior taxane exposure, such as diabetes.
Neuropathy (sensory and motor) less than or equal to CTCAE grade 1
Neuropathy(Both motor and sensory) ? Grade1 (CTCAE Version 4.0)
Neuropathy (sensory and motor) =< grade 1 according to Common Toxicity Criteria for Adverse Events version 3 (CTCAE)
Neuropathy (sensory and motor) less than or equal to grade 1
Neuropathy (sensory and motor) less than or equal to CTCAE v 4.0 grade 1
Patients with pre-existing Grade 2 (or greater) peripheral motor or sensory neurotoxicity per the CTCAE 3.0 as determined by the treating physician or a neurologist.
Evidence of baseline sensory or motor neuropathy
Neuropathy (sensory and motor) =< CTCAE v4.03 grade 1
Significant peripheral sensory or motor neuropathy at the start of the study.
Has sensory or motor neuropathy limiting daily activities.
Neurologic function: neuropathy (sensory and motor) ? CTCAE Grade 1
Current/ongoing Neuropathy (sensory or motor) Grade > 1 or any history of Grade ? 3 neuropathy with prior Vincristine or chemotherapy exposure (documentation by history is adequate to exclude)
Greater than grade 2 motor neuropathy or greater than grade 3 sensory neuropathy at screening
Neuropathy (sensory and motor) less than or equal to CTCAE grade 1
Grade 2 or greater motor or sensory neuropathy
Patient does not have a clinically significant neurologic deficit or objective peripheral neuropathy (greater than or equal to grade 2); peripheral (sensory or motor) neuropathy related to limb sparing procedure or amputation is allowed
Patients with >= grade 2 sensory or motor neuropathy are not eligible
Neuropathy (sensory or motor) less than or equal to grade 1
Able to perform motor/sensory tests
Sensory/motor neuropathy ? Grade 2
Current or prior history of grade ? 2 peripheral sensory and/or motor neuropathy.
Patients with steroid myopathy.
Known myopathy or history of rhabdomyolysis
Women taking drugs associated with a substantial risk of myopathy when co-administered with simvastatin are not eligible
Patients who have a pre-existing myopathy
DONOR: History of myopathy
History of chronic myopathy
History of chronic myopathy
DONOR: History of myopathy
History of chronic myopathy