A clinical study that compares a treatment with Iberdomide, Daratumumab and Dexamethasone against a treatment with Daratumumab, Bortezomib, and Dexamethasone in patients with a non-responsive or progressive blood cancer called Multiple Myeloma
- Conditions
- Relapsed or Refractory Multiple Myeloma (RRMM)MedDRA version: 21.0Level: LLTClassification code: 10028228Term: Multiple myeloma Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2024-510800-35-00
- Lead Sponsor
- Celgene Corp.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 864
1.Subject is = 18 years of age at the time of signing the ICF. 2.Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted. 3.Subject is willing and able to adhere to the study visit schedule and other protocol requirements. 4.Subject has documented diagnosis of MM and measurable disease, defined as any of the following: a.M-protein quantities = 1 g/dL by sPEP or = 200 mg/24-hour urine collection by uPEP; or b.Light chain MM without measurable disease in serum or urine: serum FLC levels > 100 mg/L (10 mg/dL) involved light chain and an abnormal kappa/lambda FLC ratio 5.Subject has received one to 2 prior lines of anti-myeloma therapy. 6.Subject achieved a response (PR or better) to at least 1 prior anti-myeloma regimen. 7.Subject must have documented disease progression during or after their last anti-myeloma regimen. 8.Prior treatment with CD38-directed therapy: In Stage 1, subjects with prior CD38-directed- containing therapy are not eligible. In Stage 2, prior treatment with CD38-directed therapy is permitted only if all the following are fulfilled: a.Best response achieved during CD38-directed therapy was > PR. b.Subject did not progress while receiving CD38-directed therapy or within 60 days of last dose of therapy. c.Subject did not discontinue CD38-directed therapy due to a related AE. d.Last dose of daratumumab was = 3 months prior to randomization. 9.Prior treatment with bortezomib therapy is permitted, if all the following are fulfilled: a.Best response achieved during bortezomib- containing therapy was at least a minimal response (MR). b.Subject did not progress while receiving bortezomib therapy or within 60 days of last dose of therapy. 10.Subject has an ECOG performance status score of 0, 1 or 2. 11.FCBP must: a.Have two negative pregnancy tests as verified by the Investigator prior to starting study treatment. She must agree to ongoing pregnancy testing during the course of the study, and after end of study treatment. This applies even if the subject practices true abstinence from heterosexual contact. b.Either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use, and be able to comply with, 2 forms of contraception: one highly effective, and one additional effective (barrier) measure of contraception without interruption 28 days prior to starting study treatment, during the study treatment (including dose interruptions), and for at least 28 days after the last dose of iberdomide, 3 months after the last dose of daratumumab or 7 months after the last dose of bortezomib, whichever is longest. 12.Male subjects must: a.Practice true abstinence (which must be reviewed on a monthly basis and source documented) or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 90 days after the last dose of iberdomide, 3 months after the last dose of daratumumab, or 4 months after the last dose of bortezomib, whichever is longer even if he has undergone a successful vasectomy. Contraception requirements are detailed in APPENDIX E and local PI of bortezomib and daratumumab 13.Male subjects must agree to refrain from donating sperm while on study treatment, during dose interruptions and for at least 90 days following last dose of study treatment. 14.Subjects must
1.Subject has any significant medical condition 2.SARS-CoV-2 infection within 14 days for mild or asymptomatic infections or within 28 days for severe/critical illness prior to randomization 3.Subject has any condition that confounds the ability to interpret data from the study. 4.Subject has any of the following laboratory abnormalities: a.ANC <1,000 cells/µL. It is not permissible to administer GCSF to achieve minimum ANC levels. b.Platelet count: <75,000 cells/µL for subjects in whom <50% of bone marrow nucleated cells are plasma cells; or a platelet count <50,000 cells/µL for subjects in whom =50% of bone marrow nucleated cells are plasma cells. It is not permissible to transfuse subjects to achieve minimum platelet counts c.Hemoglobin <8 g/dL (<4.9 mmol/L) d.eGFR <30 mL/min or requiring dialysis. e.Corrected serum calcium >13.5 mg/dL (>3.4 mmol/L). f.Serum AST or ALT >2.5 × ULN g.Serum total bilirubin >1.5 × ULN or >3.0 mg/dL for subjects with documented Gilbert's syndrome. 5.Subject has plasma cell leukemia, Waldenstrom's macroglobulinemia or POEMS syndrome, or clinically significant amyloidosis 6.Subject has peripheral neuropathy Grade 3, 4 or 2 with pain. 7.Subject has gastrointestinal disease that may significantly alter the absorption of iberdomide and/or other oral study treatment. 8.Subject has prior history of malignancies, other than MM, unless the subject has been free of the disease for =5 years with the exception of some noninvasive malignancies. 9.Subject with known central nervous system involvement with MM. 10.Subject has received immunosuppressive medication within the last 14 days of initiating study treatment (IST). 11.Subject has impaired cardiac function or clinically significant cardiac disease. 12.Subject received prior therapy with iberdomide. 13.Subject received any of the following from IST a.Plasmapheresis within the last 28 days b.Major surgery within 28 days c.Radiation therapy, other than local palliative therapy, for myeloma associated bone lesions within 14 days d.Use of any systemic anti-myeloma drug therapy within 14 days 14.Subject received any investigational agent within 28 days. 15.Subject has previously received a live vaccine within 3 months of IST. 16.Concurrent administration of a strong inhibitor or inducer of CYP450 (including within 14 days of IST). 17.Subject is unable or unwilling to undergo protocol required thromboembolism or herpes zoster prophylaxis. 18.Subject has previously received allogeneic stem cell transplantation at any time during prior therapy or received autologous stem cell transplantation within 12 weeks of IST. 19.Subject has known COPD with a FEV1 <50% of predicted normal. 20.Subject has known moderate or severe persistent asthma within the last 2 years, or currently has uncontrolled asthma of any classification. 21.Subject is a female who is pregnant, nursing or breastfeeding, or who intends to become pregnant during participation in the study. 22.Subject is positive for human immunodeficiency virus, chronic or active hepatitis B, A or C. 23.Subject has known allergies, hypersensitivity, or intolerance to boron or mannitol, hyaluronidase, sorbitol, corticosteroids, monoclonal antibodies or human proteins, cereblon modulating agents or their excipients or known sensitivity to mammalian-derived products. 24.Subject has any contraindications to daratumumab, bortezomib or dexamethasone, per local PI. 25. Vulnerable, under judicial protection, people without freedom by
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