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A Study of CC-95266 in Participants With Relapsed and/or Refractory Multiple Myeloma

  • Clinicaltrials.gov identifier

    NCT04674813

  • Recruitment Status

    Recruiting

  • First Posted

    December 19, 2020

  • Last update posted

    March 2, 2022

Save Trial
Clinical Trial Information for Patients Visit BMS Study Connect

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:Multiple Myeloma
  • Intervention/Treatment: Drug: CC-95266
    Drug: Fludarabine
    Drug: Cyclophosphamide
  • Phase: Phase 1

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 75 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Study of CC-95266 in Participants With Relapsed and/or Refractory Multiple Myeloma
  • Actual Study Start Date: February 2021
  • Estimated Primary Completion Date: December 2025
  • Estimated Study Completion Date: December 2025

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: 1. Number of participants with Adverse Events (AEs) [ Time Frame: Up to 2 years after CC-95266 infusion ]
  • 2. Number of participants with significant laboratory abnormalities [ Time Frame: Up to 2 years after CC-95266 infusion ]
  • 3. Number of participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Up to 2 years after CC-95266 infusion ]
  • 4. Maximum Tolerated Dose (MTD) [ Time Frame: Up to 2 years after CC-95266 infusion ]
  • 5. Recommended Phase 2 Dose (RP2D) [ Time Frame: Up to 2 years after CC-95266 infusion ]
  • Secondary Outcome Measures: 1. Pharmacokinetics - Maximum plasma concentration of drug (Cmax) [ Time Frame: Up to 2 years after CC-95266 infusion ]
  • 2. Pharmacokinetics - Time to peak (maximum) serum concentration (tmax) [ Time Frame: Up to 2 years after CC-95266 infusion ]
  • 3. Pharmacokinetics - Area under the curve for days 1-29 after CC-95266 infusion (AUC1-29) [ Time Frame: Up to 2 years after CC-95266 infusion ]
  • 4. Overall response rate (ORR) [ Time Frame: Up to 2 years after CC-95266 infusion ]
  • 5. Complete response rate (CRR) [ Time Frame: Up to 2 years after CC-95266 infusion ]
  • 6. Very good partial response (VGPR) or better [ Time Frame: Up to 2 years after CC-95266 infusion ]
  • 7. Duration of response (DOR) [ Time Frame: Up to 2 years after CC-95266 infusion ]
  • 8. Duration of complete response (DOCR) [ Time Frame: Up to 2 years after CC-95266 infusion ]
  • 9. Time to response (TTR) [ Time Frame: Up to 2 years after CC-95266 infusion ]
  • 10. Time to complete response (TTCR) [ Time Frame: Up to 2 years after CC-95266 infusion ]
  • 11. Progression-free survival (PFS) [ Time Frame: Up to 2 years after CC-95266 infusion ]
  • 12. Overall survival (OS) [ Time Frame: Up to 2 years after CC-95266 infusion ]

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

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

Contacts

Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com

Contact: First line of the email MUST contain the NCT# and Site #.

Locations

United States, Alabama
University of Alabama Birmingham
Birmingham

United States, California
City of Hope
Duarte

United States, California
University of California, San Francisco Comprehensive Cancer Center
San Francisco

United States, Colorado
Colorado Blood Cancer Institute
Denver

United States, Maryland
University of Maryland - Greenebaum Comprehensive Cancer Center
Baltimore

United States, Massachusetts
Dana Farber Cancer Institute
Boston

United States, New York
Mount Sinai Medical Center
New York

United States, Tennessee
Sarah Cannon Research Institute Center for Blood Cancers
Nashville

United States, Texas
Southwestern Medical Center- Harold C Simmons Comprehensive Cancer Center
Dallas

United States, Washington
Swedish Cancer Institute
Seattle

Sponsors and Collaborators

Juno Therapeutics, a Subsidiary of Celgene

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Juno Therapeutics, a Subsidiary of Celgene
  • ClinicalTrials.gov Identifier: NCT04674813 History of Changes
  • Other Study ID Numbers: CC-95266-MM-001, U1111-1260-4921
  • First Posted: December 19, 2020 Key Record Dates
  • Last Update Posted: March 2, 2022
  • Last Verified: February 2022

  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: Yes
  • Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
  • Supporting Materials: Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR), Analytic Code
  • Time Frame: See Plan Description
  • Access Criteria: See Plan Description
  • URL: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Juno Therapeutics, a Subsidiary of Celgene: CC-95266
    Multiple Myeloma     Relapsed and/or Refractory
  • Additional relevant MeSH terms: Multiple Myeloma
    Neoplasms, Plasma Cell
    Neoplasms by Histologic Type
    Neoplasms
    Hemostatic Disorders
    Vascular Diseases
    Cardiovascular Diseases     Paraproteinemias
    Blood Protein Disorders
    Hematologic Diseases
    Hemorrhagic Disorders
    Lymphoproliferative Disorders
    Immunoproliferative Disorders
    Immune System Diseases