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An Investigational Immuno-therapy Study of Nivolumab, Pomalidomide and Dexamethasone Combinations in Patients With Multiple Myeloma (CheckMate 602)

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: NCT02726581
Recruitment Status : Active, not recruiting
First Posted : April 1, 2016
Last Update Posted : August 29, 2019
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE March 23, 2016
First Posted Date  ICMJE April 1, 2016
Last Update Posted Date August 29, 2019
Actual Study Start Date  ICMJE April 21, 2016
Estimated Primary Completion Date March 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2018)
Progression free survival (PFS) by investigator [ Time Frame: Approximately 47 months from the time of 1st patient randomization ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 29, 2016)
  • Objective response rate (ORR) by Independent Review Committee (IRC) [ Time Frame: Approximately 18 months from the time of 1st patient randomization ]
  • Progression free survival (PFS) by IRC [ Time Frame: Approximately 23 months from the time of 1st patient randomization ]
Change History Complete list of historical versions of study NCT02726581 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2018)
  • Overall Survival (OS) [ Time Frame: Approximately 47 months from the time of 1st patient randomization ]
  • Time to objective response (TTR) by investigator [ Time Frame: Approximately 47 months from the time of 1st patient randomization ]
  • Duration of objective response (DOR) by investigator [ Time Frame: Approximately 47 months from the time of 1st patient randomization ]
  • Objective response rate (ORR) by investigator [ Time Frame: Approximately 47 months from the time of 1st patient randomization ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2016)
  • Time to objective response (TTR) [ Time Frame: Approximately 23 months from the time of 1st patient randomization ]
  • Duration of objective response (DOR) [ Time Frame: Approximately 23 months from the time of 1st patient randomization ]
  • Investigator-assessed PFS [ Time Frame: Approximately 23 months from the time of 1st patient randomization ]
  • Investigator-assessed ORR [ Time Frame: Approximately 23 months from the time of 1st patient randomization ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Investigational Immuno-therapy Study of Nivolumab, Pomalidomide and Dexamethasone Combinations in Patients With Multiple Myeloma
Official Title  ICMJE An Open-Label, Randomized Phase 3 Trial of Combinations of Nivolumab, Pomalidomide and Dexamethasone in Relapsed and Refractory Multiple Myeloma
Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of several combination therapies for Multiple Myeloma. Upon entry into the study, patients will be randomized (assigned by chance) to receive either:

Group 1: nivolumab, pomalidomide and dexamethasone OR Group 2: pomalidomide and dexamethasone OR Group 3: nivolumab, elotuzumab, pomalidomide and dexamethasone.

Enrollment is closed for all groups.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE
  • Biological: Nivolumab
    Specified dose on specified days, IV (intravenous)
    Other Name: BMS-936558
  • Biological: Elotuzumab
    Specified dose on specified days, IV
    Other Name: BMS-901608
  • Drug: Pomalidomide
    Specified dose on specified days, PO (by mouth)
  • Drug: Dexamethasone
    Specified dose on specified days, PO
Study Arms  ICMJE
  • Experimental: Investigational Arm

    Nivolumab, Pomalidomide and Dexamethasone

    Enrollment is closed for this arm

    Interventions:
    • Biological: Nivolumab
    • Drug: Pomalidomide
    • Drug: Dexamethasone
  • Active Comparator: Control Arm

    Pomalidomide and Dexamethasone

    Enrollment is closed for this arm

    Interventions:
    • Drug: Pomalidomide
    • Drug: Dexamethasone
  • Experimental: Exploratory Arm

    Nivolumab, Elotuzumab, Pomalidomide and Dexamethasone

    Enrollment is closed for this arm

    Interventions:
    • Biological: Nivolumab
    • Biological: Elotuzumab
    • Drug: Pomalidomide
    • Drug: Dexamethasone
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: May 24, 2018)
348
Original Estimated Enrollment  ICMJE
 (submitted: March 29, 2016)
406
Estimated Study Completion Date  ICMJE December 8, 2022
Estimated Primary Completion Date March 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Refractory or relapsed and refractory multiple myeloma
  • Measurable disease
  • Have received ≥ 2 lines of prior therapy which must have included an immune modulatory drug (IMiD) and a proteasome inhibitor alone or in combination

Exclusion Criteria:

  • Solitary bone or extramedullary plasmacytoma disease only
  • Active plasma cell leukemia

Other protocol defined inclusion/exclusion criteria could 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 Austria,   Canada,   Czechia,   Denmark,   Germany,   Greece,   Israel,   Italy,   Norway,   Portugal,   Puerto Rico,   Spain,   Sweden,   Switzerland,   United States
Removed Location Countries Czech Republic,   Hungary,   Mexico,   Poland,   Turkey
 
Administrative Information
NCT Number  ICMJE NCT02726581
Other Study ID Numbers  ICMJE CA209-602
2015-005699-21 ( EudraCT Number )
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 Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE AbbVie
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date August 2019

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