Open-label Study Comparing CC-92480 (BMS-986348), Carfilzomib, and Dexamethasone (480Kd) Versus Carfilzomib and Dexamethasone (Kd) in Participants with Relapsed or Refractory Multiple Myeloma (RRMM)
- Conditions
- Health Condition 1: C900- Multiple myeloma
- Registration Number
- CTRI/2023/08/056910
- Lead Sponsor
- BRISTOL MYERS SQUIBB INDIA PRIVATE LIMITED
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
? Participant has documented diagnosis of multiple myeloma (MM) and measurable disease,
defined as any of the following:
? M-protein = 0.5 g/dL by serum protein electrophoresis (sPEP), or
? M-protein = 200 mg/24-hour urine collection by urine protein electrophoresis (uPEP) or,
? For participants without measurable disease in sPEP or uPEP: serum free light chain
(sFLC) levels > 100 mg/L (10 mg/dL) involved light chain and an abnormal ?/? FLC ratio.
? Participant has received at least one prior line of anti-myeloma therapy. Note: One line can
contain several phases (eg, induction, [with or without] hematopoietic stem cell transplant,
(with or without) consolidation, and/or [with or without] maintenance therapy).
? Participant must have received prior treatment with lenalidomide and at least 2 cycles of an
anti-CD38 monoclonal antibody. Note: Patients who were intolerant of an anti-CD38 mAb and
received < 2 cycles are still eligible.
? Participant achieved minimal response [MR] or better to at least 1 prior anti-myeloma therapy.
? Participant must have documented disease progression during or after their last antimyeloma
regimen.
1. Participant who has had prior treatment with CC-92480 or carfilzomib.
2. Participant has previously received allogeneic stem cell transplant at any time or received
autologous stem cell transplant within 12 weeks of initiating study treatment.
3. Participant has any of the following laboratory values at screening:
i. Absolute neutrophil count (ANC) < 1.0 × 109 /L ( < 1,000/ µL) without growth factor
support within 7 days prior to screening complete blood count (CBC) (14 days if
pegfilgrastim is used)
ii. Platelets < 75 × 109 /L ( < 75,000/µL) and no platelet transfusions within the 7-day period
leading up to screening CBC ? Hemoglobin < 8 g/dL ( < 4.9 mmol/L)
iii. Corrected serum calcium > 13.5 mg/dL ( > 3.4 mmol/L)
iv. Estimated glomerular filtration rate (eGFR) < 30 mL/min or requiring dialysis.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the progression free survival of <br/ ><br>CC92480, carfilzomib & dexamethasone to that of carfilzomib and dexamethasone <br/ ><br>in participants with relapsed or refractory multiple myelomaTimepoint: at baseline, 8 Months and until Progression free survival up to 5 years or study achieves endpoints
- Secondary Outcome Measures
Name Time Method