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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02726581
First Posted: April 1, 2016
Last Update Posted: October 4, 2017
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.
Collaborator:
AbbVie
Information provided by (Responsible Party):
Bristol-Myers Squibb
  Purpose

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

There is an equal chance to be assigned to either Group 1 or Group 2. There is a lesser chance you will be assigned to Group 3. If you are assigned to receive pomalidomide and dexamethasone only (Group 2) and your disease worsens, you may be eligible to switch to treatment Group 3.


Condition Intervention Phase
Multiple Myeloma Biological: Nivolumab Biological: Elotuzumab Drug: Pomalidomide Drug: Dexamethasone Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Randomized Phase 3 Trial of Combinations of Nivolumab, Elotuzumab, Pomalidomide and Dexamethasone in Relapsed and Refractory Multiple Myeloma- CheckMate 602: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 602

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 406
Actual Study Start Date: April 21, 2016
Estimated Study Completion Date: August 12, 2020
Estimated Primary Completion Date: November 12, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Investigational Arm
Nivolumab, Pomalidomide and Dexamethasone
Biological: Nivolumab
Specified dose on specified days, IV (intravenous)
Other Name: BMS-936558
Drug: Pomalidomide
Specified dose on specified days, PO (by mouth)
Drug: Dexamethasone
Specified dose on specified days, PO
Active Comparator: Control Arm
Pomalidomide and Dexamethasone
Drug: Pomalidomide
Specified dose on specified days, PO (by mouth)
Drug: Dexamethasone
Specified dose on specified days, PO
Experimental: Exploratory Arm
Nivolumab, Elotuzumab, Pomalidomide and Dexamethasone
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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

  Contacts and Locations
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): NCT02726581


  Show 152 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
AbbVie
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02726581     History of Changes
Other Study ID Numbers: CA209-602
2015-005699-21 ( EudraCT Number )
First Submitted: March 23, 2016
First Posted: April 1, 2016
Last Update Posted: October 4, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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
Dexamethasone acetate
Dexamethasone
Nivolumab
Pomalidomide
Thalidomide
BB 1101
Antibodies, Monoclonal
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists