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

A Phase 1, Multicenter, Open-Label Study of CC-95266 in Subjects With Relapsed and/or Refractory Multiple Myeloma

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: Cyclophosphamide; Drug: Fludarabine; Drug: CC-95266; Drug: Bendamustine

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: BMS Study Connect Contact Center www.BMSStudyConnect.com; Phone Number: 855-907-3286; Email: Clinical.Trials@bms.com
• Study Contact Backup: Name: First line of the email MUST contain the NCT# and Site #.

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 10016
      • Local Institution - 005
  • California
    • Duarte, California, United States, 91010-301
      • Local Institution - 009
    • San Francisco, California, United States, 94143
      • Local Institution - 012
  • Colorado
    • Denver, Colorado, United States, 80218
      • Local Institution - 002
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Local Institution - 008
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Local Institution - 010
  • New York
    • New York, New York, United States, 10029
      • Local Institution - 011
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Local Institution - 001
  • Texas
    • Dallas, Texas, United States, 75390
      • Local Institution - 006
  • Washington
    • Seattle, Washington, United States, 98104
      • Local Institution - 003

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Administration of CC-95266	Drug: Cyclophosphamide; Specified dose on specified days; Drug: Fludarabine; Specified dose on specified days; Drug: CC-95266; Specified dose on specified days; Drug: Bendamustine; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Juno Therapeutics, a Subsidiary of Celgene
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2021
• Primary Completion (Estimated): June 7, 2025
• Study Completion (Estimated): June 7, 2025

Study Registration Dates

• First Submitted: December 14, 2020
• First Submitted That Met QC Criteria: December 14, 2020
• First Posted (Actual): December 19, 2020

Study Record Updates

• Last Update Posted (Actual): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Multiple Myeloma; Relapsed and/or Refractory; CC-95266
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Cyclophosphamide; Bendamustine Hydrochloride; Fludarabine
• Other Study ID Numbers: CC-95266-MM-001; U1111-1260-4921 (Registry Identifier: WHO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD 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/

• IPD Sharing Time Frame: See Plan Description
• IPD Sharing Access Criteria: See Plan Description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No