Subjects who have initiated treatment with bisphosphonates less than 30 days prior to the first administration of MLN0128 (TAK-228); concurrent bisphosphonate use is only allowed if the bisphosphonate was initiated at least 30 days prior to the first administration of MLN0128 (TAK-228)
Prior bisphosphonate use is permitted
Bisphosphonates will not be allowed on the study while the participant is receiving sotatercept; prior bisphosphonate use is allowed
Patients on bisphosphonates may continue receiving bisphosphonate therapy during study treatment
Have initiated treatment with bisphosphonates less than 30 days prior to study registration; concurrent bisphosphonate use is only allowed if the bisphosphonate was initiated at least 30 days prior to study registration
Patients on bisphosphonates may continue receiving bisphosphonate therapy during study; patients wanting to initiate bisphosphonate therapy may do so
Subjects on bisphosphonate therapy must be on a stable dose and must have started therapy > 4 weeks prior to protocol therapy.
Patients on bisphosphonates may continue receiving bisphosphonate therapy during study treatment
Patients who are currently receiving bisphosphonate derivatives are not eligible
Participants on bisphosphonates may continue receiving bisphosphonate therapy during study treatment
Initiating bisphosphonate, or RANKL antibody therapy or adjusting the dose/regimen within 30 days prior to cycle 1 day 1 is prohibited; patients on a stable bisphosphonate regimen are eligible and may continue
Participants on bisphosphonates may continue receiving bisphosphonate therapy during study treatment
Use of bisphosphonate therapy for osteoporosis will be allowed if started prior to study enrollment
Bisphosphonate treatment within 7 days prior to initiating study treatment (while on study, bisphosphonates can be administered only once a month, between Days 18 to 21 of the 28-day treatment cycle)
Has received prior bisphosphonate therapy
Treatment within the past two years with a bisphosphonate or a Rank ligand inhibitor
Concurrent bisphosphonate therapy is not excluded, however patients should not start bisphosphonate therapy while on this study; those patients already receiving bisphosphonate therapy should continue at the same dosing and schedule as prior to study entry
Concurrent bisphosphonate or receptor activator of nuclear factor kappa-B (RANK)-ligand directed therapy for prevention of skeletal related events or treatment of osteoporosis is allowed
Have initiated treatment with bisphosphonates less than 30 days prior to the first administration of MLN0128 (TAK-228); concurrent bisphosphonate use is only allowed if the bisphosphonate was initiated at least 30 days prior to the first administration of MLN0128 (TAK-228)
Initiation or discontinuation of bisphosponate use within past 14 days\r\n* Continuation of use is allowed but patients must continue bisphosphonate throughout the treatment and follow up period until disease progression
Active intravenous (IV) bisphosphonate use in the last 3 months
Co-administration of enzyme-inducing antiepileptic drugs, rifampin, rifabutin, rifapentine, or St. John’s wort is not permitted; concurrent bisphosphonate therapy is allowed if it was started before study entry and is maintained at recommended dosing intervals; bisphosphonate therapy may not be initiated after study entry
Concurrent use of bisphosphonates is not permitted; however, prior bisphosphonates or once-a-year intravenous bisphosphonate given for the treatment of osteoporosis is permitted
Participants receiving bone resorptive therapy (including, but not limited to bisphosphonate or receptor activator of nuclear factor kappa-? ligand inhibitor) must be on stable doses for ?4 weeks prior to first dose of study therapy
Participants receiving bone resorptive therapy (including but not limited to bisphosphonate or RANK-L inhibitor) must have therapy initiated at least 2 weeks prior to treatment allocation.
If receiving bone resorptive therapy (including but not limited to bisphosphonate or RANK-L inhibitor) must have therapy initiated at least 2 weeks prior to randomization.
Prior or ongoing bisphosphonate (e.g,. zoledronic acid) or RANKL inhibitor (e.g. denosumab) use is NOT allowed except when used solely for osteoporosis and strictly per guidelines for that indication. Bisphosphonate or RANKL inhibitor cannot be initiated for any indication during protocol specified therapy without consent of the sponsor-investigator of the study.
No current anti-myeloma bisphosphonate therapy (however, prior bisphosphonates and/or bisphosphonate therapy due to osteoporosis is allowed)
Patients may have initiated bisphosphonate therapy prior to start of protocol therapy; bisphosphonate therapy may continue during protocol treatment; such patients will have bone lesions considered evaluable for progression
Current or previous chemotherapy or bisphosphonate therapy is permissible
Patient can be receiving bisphosphonate therapy per the treating oncologist's discretion.
Patients may have initiated bisphosphonate therapy prior to start of protocol therapy; bisphosphonate therapy may continue during protocol treatment; such patients will have bone lesions considered evaluable for progression
Patients receiving bisphosphonate therapy must have been on stable doses for at least 4 weeks with stable symptoms prior to the first infusion with ipilimumab
Bisphosphonate or receptor activated of nuclear factor kappa-B (RANK) ligand inhibitor therapy for bone metastases is allowed; prophylactic use of bisphosphonates in subjects without bone disease, except for the treatment of osteoporosis, is not permitted
Patients may receive a bisphosphonate.
Patients may not initiate bisphosphonate therapy while receiving treatment on this study; patients who have begun receiving bisphosphonate therapy prior to registration may continue at the same intervals used prior to study registration
Prior or current IV bisphosphonate administration
Bisphosphonate therapy currently or within the past 12 months
Concurrent bisphosphonate treatment
No radiation therapy to targeted (most painful) lesion in the past two weeks Bisphosphonate intake should remain stable throughout the study duration.
Patients undergoing bisphosphonate therapy are allowed
More than 1 previous dose of IV bisphosphonate administration
Patients with current or previous bisphosphonate therapy
Patients who have initiated treatment with bisphosphonates less than 30 days prior to the first administration of MLN0128 (TAK-228) are ineligible; concurrent bisphosphonate use is only allowed if the bisphosphonate was initiated at least 30 days prior to the first administration of MLN0128 (TAK-228)
Patients currently using oral bisphosphonate therapy