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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Multiple Myeloma

Treatments: Biological: Elotuzumab; Drug: Pomalidomide; Biological: Nivolumab; Drug: Dexamethasone

Study type: Interventional

Funder types: Industry

Identifiers

NCT02726581

2015-005699-21 (EudraCT Number)

CA209-602

Details and patient eligibility

About

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.

Enrollment: 170 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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170 participants in 3 patient groups

Investigational Arm

Experimental group

Description:

Nivolumab, Pomalidomide and Dexamethasone Enrollment is closed for this arm

Treatment:

Drug: Dexamethasone

Drug: Pomalidomide

Biological: Nivolumab

Control Arm

Active Comparator group

Description:

Pomalidomide and Dexamethasone Enrollment is closed for this arm

Treatment:

Drug: Dexamethasone

Drug: Pomalidomide

Exploratory Arm

Experimental group

Description:

Nivolumab, Elotuzumab, Pomalidomide and Dexamethasone Enrollment is closed for this arm

Treatment:

Drug: Dexamethasone

Drug: Pomalidomide

Biological: Nivolumab

Biological: Elotuzumab