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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04674813
Recruitment Status : Active, not recruiting
First Posted : December 19, 2020
Last Update Posted : January 26, 2024
Sponsor:
Information provided by (Responsible Party):
Juno Therapeutics, a Subsidiary of Celgene

Study Description
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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
Multiple Myeloma Drug: CC-95266 Drug: Fludarabine Drug: Cyclophosphamide Drug: Bendamustine Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Multicenter, Open-Label Study of CC-95266 in Subjects With Relapsed and/or Refractory Multiple Myeloma
Actual Study Start Date : February 24, 2021
Estimated Primary Completion Date : June 7, 2025
Estimated Study Completion Date : June 7, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
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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

Drug: Bendamustine
Specified dose on specified days


Outcome Measures
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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
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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 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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04674813


Locations
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United States, Alabama
Local Institution - 005
Birmingham, Alabama, United States, 10016
United States, California
Local Institution - 009
Duarte, California, United States, 91010-301
Local Institution - 012
San Francisco, California, United States, 94143
United States, Colorado
Local Institution - 002
Denver, Colorado, United States, 80218
United States, Maryland
Local Institution - 008
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Local Institution - 010
Boston, Massachusetts, United States, 02115
United States, New York
Local Institution - 011
New York, New York, United States, 10029
United States, Tennessee
Local Institution - 001
Nashville, Tennessee, United States, 37203
United States, Texas
Local Institution - 006
Dallas, Texas, United States, 75390
United States, Washington
Local Institution - 003
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Juno Therapeutics, a Subsidiary of Celgene
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Juno Therapeutics, a Subsidiary of Celgene
ClinicalTrials.gov Identifier: NCT04674813    
Other Study ID Numbers: CC-95266-MM-001
U1111-1260-4921 ( Registry Identifier: WHO )
First Posted: December 19, 2020    Key Record Dates
Last Update Posted: January 26, 2024
Last Verified: January 2024
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/

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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:
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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
Cyclophosphamide
Bendamustine Hydrochloride
Fludarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists