Multiple Myeloma
Conditions
Keywords
CC-95266, Multiple Myeloma, Relapsed and/or Refractory
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).
Interventions
DRUGCC-95266
Specified dose on specified days
DRUGFludarabine
Specified dose on specified days
DRUGCyclophosphamide
Specified dose on specified days
DRUGBendamustine
Specified dose on specified days
Sponsors
Juno Therapeutics, a Subsidiary of Celgene
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| Number of participants with Adverse Events (AEs) | Up to 2 years after CC-95266 infusion |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) | Up to 2 years after CC-95266 infusion |
| Overall survival (OS) | 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 |
| Pharmacokinetics - Maximum plasma concentration of drug (Cmax) | 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 |
Countries
United States
Contacts
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed