An investigational immuno-therapy study of Nivolumab, Pomalidomide and Dexamethasone combinations in patients with Multiple Myeloma

An Open-Label, Randomized Phase 3 Trial of Combinations of Nivolumab, Pomalidomide and Dexamethasone in Relapsed and Refractory Multiple Myeloma

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-005699-21-AT

Enrollment

512

Registered

2016-05-20

Start date

2016-06-21

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

relapsed and refractory Multiple Myeloma MedDRA version: 20.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864

Interventions

Trade Name: Empliciti (400 mg) Product Name: Elotuzumab Product Code: BMS-901608 Pharmaceutical Form: Powder for concentrate for solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 154 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 358

Exclusion criteria

Exclusion criteria: - Solitary bone or extramedullary plasmacytoma disease only - Active plasma cell leukemia

Design outcomes

Primary

Measure	Time frame
Secondary Objective: • To estimate overall survival (OS) within N-Pd and Pd arms • To assess the time to objective response (TTR) within N-Pd and Pd arms by investigator • To assess the duration of objective response (DOR) within N-Pd and Pd arms by investigator • To compare ORR between N-Pd and Pd arms, by investigator. ;Main Objective: The primary objective is to compare progression free survival (PFS) between N-Pd and Pd arms, by investigator;Primary end point(s): 1. Progression free survival (PFS) by investigator;Timepoint(s) of evaluation of this end point: 1. Approximately 47 months from the time of 1st patient randomization	—

Measure

Time frame

Secondary Objective: • To estimate overall survival (OS) within N-Pd and Pd arms • To assess the time to objective response (TTR) within N-Pd and Pd arms by investigator • To assess the duration of objective response (DOR) within N-Pd and Pd arms by investigator • To compare ORR between N-Pd and Pd arms, by investigator. ;Main Objective: The primary objective is to compare progression free survival (PFS) between N-Pd and Pd arms, by investigator;Primary end point(s): 1. Progression free survival (PFS) by investigator;Timepoint(s) of evaluation of this end point: 1. Approximately 47 months from the time of 1st patient randomization

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Secondary

Measure	Time frame
Secondary end point(s): 1.To assess the time to objective response (TTR) by Investigator 2.To assess the duration of objective response (DOR) by investigator 3. Objective response rate (ORR) by investigator 4. Overall Survival (OS) ; Timepoint(s) of evaluation of this end point: 1, Approximately 47 months from the time of 1st patient randomization 2. Approximately 47 months from the time of 1st patient randomization 3. Approximately 47 months from the time of 1st patient randomization 4. Approximately 47 months from the time of 1st patient randomization	—

Measure

Time frame

Secondary end point(s): 1.To assess the time to objective response (TTR) by Investigator 2.To assess the duration of objective response (DOR) by investigator 3. Objective response rate (ORR) by investigator 4. Overall Survival (OS) ; Timepoint(s) of evaluation of this end point: 1, Approximately 47 months from the time of 1st patient randomization 2. Approximately 47 months from the time of 1st patient randomization 3. Approximately 47 months from the time of 1st patient randomization 4. Approximately 47 months from the time of 1st patient randomization

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Countries

Austria, Canada, Czech Republic, Denmark, Germany, Greece, Israel, Italy, Norway, Poland, Portugal, Spain, Sweden, Switzerland, United States

Contacts

Public ContactGCT-SU

Bristol-Myers Squibb International Corporation

clinical.trials@bms.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026