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

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ClinicalTrials.gov Identifier: NCT02726581
Recruitment Status : Active, not recruiting
First Posted : April 1, 2016
Last Update Posted : October 9, 2018
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Bristol-Myers Squibb

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 Group 3.

There is an equal chance to be assigned to either Group 1 or Group 2. Group 3 is no longer open for enrollment.


Condition or disease Intervention/treatment Phase
Multiple Myeloma Biological: Nivolumab Biological: Elotuzumab Drug: Pomalidomide Drug: Dexamethasone Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 348 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Randomized Phase 3 Trial of Combinations of Nivolumab, Pomalidomide and Dexamethasone in Relapsed and Refractory Multiple Myeloma
Actual Study Start Date : April 21, 2016
Estimated Primary Completion Date : March 15, 2020
Estimated Study Completion Date : December 8, 2022


Arm Intervention/treatment
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

Enrollment is closed for this arm

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




Primary Outcome Measures :
  1. Progression free survival (PFS) by Independent Review Committee (IRC) [ Time Frame: Approximately 47 months from the time of 1st patient randomization ]

Secondary Outcome Measures :
  1. Time to objective response (TTR) [ Time Frame: Approximately 47 months from the time of 1st patient randomization ]
  2. Duration of objective response (DOR) [ Time Frame: Approximately 47 months from the time of 1st patient randomization ]
  3. Investigator-assessed PFS [ Time Frame: Approximately 47 months from the time of 1st patient randomization ]
  4. Investigator-assessed ORR [ Time Frame: Approximately 47 months from the time of 1st patient randomization ]
  5. Objective response rate (ORR) by IRC [ Time Frame: Approximately 47 months from the time of 1st patient randomization ]
  6. Overall Survival (OS) [ Time Frame: Approximately 47 months from the time of 1st patient randomization ]


Information from the National Library of Medicine

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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

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


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 117 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
AbbVie
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

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 Posted: April 1, 2016    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018

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