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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

Tracking Information
First Submitted Date  ICMJE December 14, 2020
First Posted Date  ICMJE December 19, 2020
Last Update Posted Date January 26, 2024
Actual Study Start Date  ICMJE February 24, 2021
Estimated Primary Completion Date June 7, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 10, 2022)
  • Number of participants with Adverse Events (AEs) [ Time Frame: Up to 2 years after CC-95266 infusion ]
  • Number of participants with significant laboratory abnormalities [ Time Frame: Up to 2 years after CC-95266 infusion ]
  • Number of participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Up to 2 years after CC-95266 infusion ]
  • Maximum Tolerated Dose (MTD) [ Time Frame: Up to 2 years after CC-95266 infusion ]
  • Recommended Phase 2 Dose (RP2D) [ Time Frame: Up to 2 years after CC-95266 infusion ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 14, 2020)
  • Adverse Events (AEs) [ Time Frame: Up to 2 years after CC-95266 infusion ]
    An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.
  • Maximum Tolerated Dose (MTD) [ Time Frame: Up to 2 years after CC-95266 infusion ]
    MTD is defined as the dose level that can be given such that the estimated DLT probability is closest to approximately 30%
  • Recommended Phase 2 Dose (RP2D) [ Time Frame: Up to 2 years after CC-95266 infusion ]
    RP2D is defined as the dose recommended for further investigation in a Phase 2 study
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2022)
  • Pharmacokinetics - Maximum plasma concentration of drug (Cmax) [ Time Frame: Up to 2 years after CC-95266 infusion ]
  • Pharmacokinetics - Time to peak (maximum) serum concentration (tmax) [ Time Frame: Up to 2 years after CC-95266 infusion ]
  • 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 ]
  • Overall response rate (ORR) [ Time Frame: Up to 2 years after CC-95266 infusion ]
  • Complete response rate (CRR) [ Time Frame: Up to 2 years after CC-95266 infusion ]
  • Very good partial response (VGPR) or better [ Time Frame: Up to 2 years after CC-95266 infusion ]
  • Duration of response (DOR) [ Time Frame: Up to 2 years after CC-95266 infusion ]
  • Duration of complete response (DOCR) [ Time Frame: Up to 2 years after CC-95266 infusion ]
  • Time to response (TTR) [ Time Frame: Up to 2 years after CC-95266 infusion ]
  • Time to complete response (TTCR) [ Time Frame: Up to 2 years after CC-95266 infusion ]
  • Progression-free survival (PFS) [ Time Frame: Up to 2 years after CC-95266 infusion ]
  • Overall survival (OS) [ Time Frame: Up to 2 years after CC-95266 infusion ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2020)
  • Pharmacokinetics - Cmax [ Time Frame: Up to 2 years after CC-95266 infusion ]
    Cmax is defined as maximum plasma concentration of drug
  • Pharmacokinetics - tmax [ Time Frame: Up to 2 years after CC-95266 infusion ]
    tmax is defined as time to peak (maximum) serum concentration
  • Pharmacokinetics - AUC(1-29) [ Time Frame: Up to 2 years after CC-95266 infusion ]
    AUC(1-29) is defined as area under the curve for days 1-29 after CC-95266 infusion
  • Overall response rate (ORR) [ Time Frame: Up to 2 years after CC-95266 infusion ]
    ORR is defined as proportion of subjects achieving sCR, CR, VGPR, or PR
  • Complete response rate (CRR) [ Time Frame: Up to 2 years after CC-95266 infusion ]
    CRR is defined as proportion of subjects with sCR or CR
  • Duration of response (DOR) [ Time Frame: Up to 2 years after CC-95266 infusion ]
    DOR is defined as the time from first response (sCR, CR, VGPR, or PR) to PD or death
  • Duration of complete response (DOCR) [ Time Frame: Up to 2 years after CC-95266 infusion ]
    DOCR is defined as a best overall response of sCR or CR, time from first response (sCR, CR, VGPR, or PR) to the first documentation of PD or death
  • Time to response (TTR) [ Time Frame: Up to 2 years after CC-95266 infusion ]
    TTR is defined as time from CC-95266 infusion to the first documentation of response (sCR, CR, VGPR, or PR)
  • Time to complete response (TTCR) [ Time Frame: Up to 2 years after CC-95266 infusion ]
    TTCR is defined as time from CC-95266 infusion to the first documentation of sCR or CR
  • Progression-free survival (PFS) [ Time Frame: Up to 2 years after CC-95266 infusion ]
    PFS is defined as time from CC-95266 infusion to the first documentation of PD, or death from any cause, whichever occurs first
  • Overall survival (OS) [ Time Frame: Up to 2 years after CC-95266 infusion ]
    OS is defined as time from CC-95266 infusion to death
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of CC-95266 in Participants With Relapsed and/or Refractory Multiple Myeloma
Official Title  ICMJE A Phase 1, Multicenter, Open-Label Study of CC-95266 in Subjects With Relapsed and/or Refractory Multiple Myeloma
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: Administration of CC-95266
Interventions:
  • Drug: CC-95266
  • Drug: Fludarabine
  • Drug: Cyclophosphamide
  • Drug: Bendamustine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: February 8, 2023)		 180
Original Estimated Enrollment  ICMJE
 (submitted: December 14, 2020)		 75
Estimated Study Completion Date  ICMJE June 7, 2025
Estimated Primary Completion Date June 7, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04674813
Other Study ID Numbers  ICMJE CC-95266-MM-001
U1111-1260-4921 ( Registry Identifier: WHO )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: 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/
Current Responsible Party Juno Therapeutics, a Subsidiary of Celgene
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Juno Therapeutics, a Subsidiary of Celgene
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Juno Therapeutics, a Subsidiary of Celgene
Verification Date January 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP