Multiple Myeloma Clinical Trial
Official title:
A Phase 1, Multicenter, Open-Label Study of CC-95266 in Subjects With Relapsed and/or Refractory Multiple Myeloma
| Verified date | January 2024 |
| Source | Juno Therapeutics, a Subsidiary of Celgene |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to evaluate the safety and preliminary efficacy of CC-95266 in participants with relapsed and/or refractory multiple myeloma (R/R MM).
| Status | Active, not recruiting |
| Enrollment | 180 |
| Est. completion date | June 7, 2025 |
| Est. primary completion date | June 7, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Age = 18 years - Participant has a diagnosis of multiple myeloma (MM) with relapsed and/or refractory disease. Participants must have confirmed progressive disease (as per IMWG criteria) on or within 12 months of completing treatment with the last anti-myeloma treatment regimen before study entry or have confirmed progressive disease within 6 months prior to screening and who are subsequently determined to be refractory or non-responsive to their most recent anti-myeloma treatment regimen, except for participants with cellular therapy (e.g., Chimeric antigen receptor (CAR) T-cell therapy) as their last treatment, who may enroll beyond 12 months. - Participants in Part A, and Part B Cohort A, and Part B Cohort B must have received at least 3 prior anti-myeloma treatment regimens (note: induction with or without hematopoietic stem cell transplant (HSCT) and with or without maintenance therapy is considered one regimen).Subjects in Part B Cohort C only must have received at least 1 but not greater than 3 prior anti-myeloma treatment regimens, including a proteasome inhibitor and immunomodulatory agent including: - Autologous HSCT, unless the subject was ineligible - A regimen that included an immunomodulatory agent (e.g., thalidomide, lenalidomide, pomalidomide) and a proteasome inhibitor (e.g., bortezomib, carfilzomib, ixazomib), either alone or combination - Anti-CD38 (e.g., daratumumab), either alone or combination. Subjects in Cohort C do not require prior anti-CD38 antibody therapy. - Measurable disease - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Adequate organ function Exclusion Criteria: - Known active or history of central nervous system (CNS) involvement of MM - Active or history of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) syndrome, or clinically significant amyloidosis - Active autoimmune disease requiring immunosuppressive therapy - History or presence of clinically significant CNS pathology such as seizure disorder, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, or psychosis Other protocol-defined inclusion/exclusion criteria apply. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Local Institution - 008 | Baltimore | Maryland |
| United States | Local Institution - 005 | Birmingham | Alabama |
| United States | Local Institution - 010 | Boston | Massachusetts |
| United States | Local Institution - 006 | Dallas | Texas |
| United States | Local Institution - 002 | Denver | Colorado |
| United States | Local Institution - 009 | Duarte | California |
| United States | Local Institution - 001 | Nashville | Tennessee |
| United States | Local Institution - 011 | New York | New York |
| United States | Local Institution - 012 | San Francisco | California |
| United States | Local Institution - 003 | Seattle | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| Juno Therapeutics, a Subsidiary of Celgene |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of participants with Adverse Events (AEs) | Up to 2 years after CC-95266 infusion | ||
| Primary | Number of participants with significant laboratory abnormalities | Up to 2 years after CC-95266 infusion | ||
| Primary | Number of participants with Dose Limiting Toxicities (DLTs) | Up to 2 years after CC-95266 infusion | ||
| Primary | Maximum Tolerated Dose (MTD) | Up to 2 years after CC-95266 infusion | ||
| Primary | Recommended Phase 2 Dose (RP2D) | Up to 2 years after CC-95266 infusion | ||
| Secondary | Pharmacokinetics - Maximum plasma concentration of drug (Cmax) | Up to 2 years after CC-95266 infusion | ||
| Secondary | Pharmacokinetics - Time to peak (maximum) serum concentration (tmax) | Up to 2 years after CC-95266 infusion | ||
| Secondary | Pharmacokinetics - Area under the curve for days 1-29 after CC-95266 infusion (AUC1-29) | Up to 2 years after CC-95266 infusion | ||
| Secondary | Overall response rate (ORR) | Up to 2 years after CC-95266 infusion | ||
| Secondary | Complete response rate (CRR) | Up to 2 years after CC-95266 infusion | ||
| Secondary | Very good partial response (VGPR) or better | Up to 2 years after CC-95266 infusion | ||
| Secondary | Duration of response (DOR) | Up to 2 years after CC-95266 infusion | ||
| Secondary | Duration of complete response (DOCR) | Up to 2 years after CC-95266 infusion | ||
| Secondary | Time to response (TTR) | Up to 2 years after CC-95266 infusion | ||
| Secondary | Time to complete response (TTCR) | Up to 2 years after CC-95266 infusion | ||
| Secondary | Progression-free survival (PFS) | Up to 2 years after CC-95266 infusion | ||
| Secondary | Overall survival (OS) | Up to 2 years after CC-95266 infusion |
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