A trial to determine the safety and effectiveness of CC-92480 in combination with bortezomib and dexamethasone as compared to pomalidomide in combination with bortezomib and dexamethasone in people who have Multiple Myeloma that is not responsive after treatment or has returned after a period of treatment.
- Conditions
- Relapsed or Refractory Multiple Myeloma (RRMM)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2021-001957-30-IE
- Lead Sponsor
- Celgene Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 950
•Subject has documented diagnosis of MM and measurable disease, defined as:
—M-protein = 0.5 g/dL by serum protein electrophoresis (sPEP), or = 200 mg/24-hour urine collection by urine protein electrophoresis (uPEP) or,
—For subjects 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 kappa/lambda FLC ratio
•Subject has received 1 to 3 prior anti-myeloma lines of therapy
•Subject must have received prior treatment with a lenalidomide containing regimen. For country-specific requirements, see APPENDIX I
•Subject achieved a minimal response [MR] or better to at least 1 prior antimyeloma therapy
•Subject must have documented disease progression during or after their last antimyeloma regimen
•Subject has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 418
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 532
•Subject has had prior treatment with mezigdomideor pomalidomide
•Subject has had progression during treatment or within 60 days of the last dose of a proteasome inhibitor , except as noted below:
a. Subjects who progressed while being treated with, or within 60 days of last dose of bortezomib maintenance given once every 2 weeks or less are not excluded.
•Subject discontinued prior treatment with bortezomib due to toxicity
•Any of the following laboratory abnormalities:
—ANC < 1,000/µL (no GCSF allowed within 7 days prior to the CBC which will be used to determine eligibility or within 14 prior days for pegfilgrastim)
—Platelet : < 75,000/µL for subjects in whom < 50% of bone marrow nucleated cells are plasma cells; or a platelet count < 50,000/µL for subjects in whom = 50% of bone marrow nucleated cells are plasma cells (transfusions are not permitted within 7 days prior to the CBC which will be used to determine eligibility)
—Hemoglobin < 8 g/dL (< 4.9 mmol/L). Not applicable for Protocol Amendment 4 and later.
—eGFR < 30 mL/min/1.73m2 or requiring dialysis
—Corrected serum calcium > 13.5 mg/dL (> 3.4 mmol/L)
—AST or ALT > 2.5 × ULN
—Serum total bilirubin > 1.5 × ULN, or for subjects with documented Gilbert’s syndrome > 3.0 mg/dL
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method