A Study of CC-95266 in Participants With Relapsed and/or Refractory Multiple Myeloma
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Administration of CC-95266
|
Drug: CC-95266
Specified dose on specified days
Drug: Fludarabine
Specified dose on specified days
Drug: Cyclophosphamide
Specified dose on specified days
|
Outcome Measures
Primary Outcome Measures
- Number of participants with Adverse Events (AEs) [Up to 2 years after CC-95266 infusion]
- Number of participants with significant laboratory abnormalities [Up to 2 years after CC-95266 infusion]
- Number of participants with Dose Limiting Toxicities (DLTs) [Up to 2 years after CC-95266 infusion]
- Maximum Tolerated Dose (MTD) [Up to 2 years after CC-95266 infusion]
- Recommended Phase 2 Dose (RP2D) [Up to 2 years after CC-95266 infusion]
Secondary Outcome Measures
- Pharmacokinetics - Maximum plasma concentration of drug (Cmax) [Up to 2 years after CC-95266 infusion]
- Pharmacokinetics - Time to peak (maximum) serum concentration (tmax) [Up to 2 years after CC-95266 infusion]
- Pharmacokinetics - Area under the curve for days 1-29 after CC-95266 infusion (AUC1-29) [Up to 2 years after CC-95266 infusion]
- Overall response rate (ORR) [Up to 2 years after CC-95266 infusion]
- Complete response rate (CRR) [Up to 2 years after CC-95266 infusion]
- Very good partial response (VGPR) or better [Up to 2 years after CC-95266 infusion]
- Duration of response (DOR) [Up to 2 years after CC-95266 infusion]
- Duration of complete response (DOCR) [Up to 2 years after CC-95266 infusion]
- Time to response (TTR) [Up to 2 years after CC-95266 infusion]
- Time to complete response (TTCR) [Up to 2 years after CC-95266 infusion]
- Progression-free survival (PFS) [Up to 2 years after CC-95266 infusion]
- Overall survival (OS) [Up to 2 years after CC-95266 infusion]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age ≥ 18 years
-
Participant has a diagnosis of multiple myeloma (MM) with relapsed and/or refractory disease Participants must have documented progressive disease on or within 12 months of completing treatment with the last anti-myeloma treatment regimen, except for participants with cellular therapy (eg, Chimeric antigen receptor (CAR) T-cell therapy) as their last treatment, who may enroll beyond 12 months
-
Participants 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), including:
-
Autologous stem cell transplant
-
A regimen that included an immunomodulatory agent (eg, thalidomide, lenalidomide, pomalidomide) and a proteasome inhibitor (eg, bortezomib, carfilzomib, ixazomib), either alone or combination
-
Anti-CD38 (eg, daratumumab), either alone or combination
-
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, organic brain syndrome, or psychosis
Other protocol-defined inclusion/exclusion criteria apply
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama Birmingham | Birmingham | Alabama | United States | 10016 |
| 2 | City of Hope | Duarte | California | United States | 91010-301 |
| 3 | University of California, San Francisco Comprehensive Cancer Center | San Francisco | California | United States | 94143 |
| 4 | Colorado Blood Cancer Institute | Denver | Colorado | United States | 80218 |
| 5 | Colorado Blood Cancer Institute | Denver | Colorado | United States | 80218 |
| 6 | University of Maryland - Greenebaum Comprehensive Cancer Center | Baltimore | Maryland | United States | 21201 |
| 7 | University of Maryland - Greenebaum Comprehensive Cancer Center | Baltimore | Maryland | United States | 21201 |
| 8 | Dana Farber Cancer Institute | Boston | Massachusetts | United States | 02115 |
| 9 | Dana Farber Cancer Institute | Boston | Massachusetts | United States | 02115 |
| 10 | Mount Sinai Medical Center | New York | New York | United States | 10029 |
| 11 | Sarah Cannon Research Institute Center for Blood Cancers | Nashville | Tennessee | United States | 37203 |
| 12 | Southwestern Medical Center- Harold C Simmons Comprehensive Cancer Center | Dallas | Texas | United States | 75390 |
| 13 | Southwestern Medical Center- Harold C Simmons Comprehensive Cancer Center | Dallas | Texas | United States | 75390 |
| 14 | Swedish Cancer Institute | Seattle | Washington | United States | 98104 |
Sponsors and Collaborators
- Juno Therapeutics, a Subsidiary of Celgene
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- BMS Clinical Trial Information
- BMS Clinical Trial Patient Recruiting
- FDA Safety Alerts and Recalls
- Investigator Inquiry Form
Publications
None provided.- CC-95266-MM-001
- U1111-1260-4921