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

NCT02726581 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: CA209-6022015-005699-21
• Study Type: interventional
• Target: 170
• Locations: 16 countries
• Sites: 121

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  Randomization to first documented tumor progression or death due to any cause, whichever occurred first. Participants who die without reported prior progression are considered to have progressed on date of their death. Participants who did not progress or die will be censored at their last efficacy assessment. Participants who did not have on study efficacy assessments and alive will be censored on randomization date. Participants who started subsequent anti-cancer therapy without prior reported progression will be censored at last efficacy assessment prior to subsequent anti-cancer therapy. Progression is 1) increase of 25% from lowest confirmed response value in specific Serum M-protein and Urine M-protein criteria and increase of FLC for patients with no measurable M protein in blood or urine at baseline and/or 2) appearance of a new lesion(s), \>/= 50% increase from nadir in SPD of \> 1 lesion, or \>/= 50% increase in the longest diameter of a previous lesion \> 1 cm in short axis.

  From randomization to the date of the first documented tumor progression or death due to any cause, whichever occurred first (Up to approximately 64 month)

Secondary Outcomes (4)

• Overall Survival (OS)

  From randomization to the date of death due to any cause (up to approximately 64 months)

• Objective Response Rate (ORR)

  From randomization up to approximately 64 months

• Time to Objective Response (TTR)

  From the date of randomization to the date of the first sCR, CR, VGPR, or PR (up to approximately 64 months)

• Duration of Objective Response (DOR)

  From randomization to the date of the first objectively documented tumor progression or death due to any cause prior to subsequent anti-cancer therapy (up to approximately 64 months)

Study Arms (3)

Investigational Arm

EXPERIMENTAL

Nivolumab, Pomalidomide and Dexamethasone Enrollment is closed for this arm

Biological: Nivolumab; Drug: Pomalidomide; Drug: Dexamethasone

Control Arm

ACTIVE COMPARATOR

Pomalidomide and Dexamethasone Enrollment is closed for this arm

Drug: Pomalidomide; Drug: Dexamethasone

Exploratory Arm

EXPERIMENTAL

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

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

Interventions

Nivolumab BIOLOGICAL

Specified dose on specified days, IV (intravenous)

Also known as: BMS-936558

Exploratory Arm; Investigational Arm

Elotuzumab BIOLOGICAL

Specified dose on specified days, IV

Also known as: BMS-901608

Exploratory Arm

Pomalidomide DRUG

Specified dose on specified days, PO (by mouth)

Control Arm; Exploratory Arm; Investigational Arm

Dexamethasone DRUG

Specified dose on specified days, PO

Control Arm; Exploratory Arm; Investigational Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• AbbVie: collaborator

Study Sites (121)

Local Institution - 0020

Birmingham, Alabama, 35294-3300, United States

Location

Local Institution - 0160

Mobile, Alabama, 36608, United States

Location

Local Institution - 0163

Fayetteville, Arkansas, 72703, United States

Location

Local Institution - 0118

Bakersfield, California, 93309, United States

Location

Local Institution - 0093

Corona, California, 92879, United States

Location

Local Institution - 0016

Fountain Valley, California, 92708, United States

Location

Local Institution - 0164

La Jolla, California, 92037, United States

Location

UC San Diego Moores Cancer Ctr

La Jolla, California, 92093-0698, United States

Location

Local Institution - 0138

Los Angeles, California, 90017, United States

Location

Local Institution - 0155

Los Angeles, California, 90095, United States

Location

Local Institution - 0117

Redondo Beach, California, 90277, United States

Location

Local Institution - 0092

Riverside, California, 92501, United States

Location

Coastal Integrative Cancer Care

San Luis Obispo, California, 93401, United States

Location

Local Institution - 0113

Santa Maria, California, 93454, United States

Location

Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States

Location

Poudre Valley Health Care

Fort Collins, Colorado, 80528, United States

Location

Local Institution - 0116

Grand Junction, Colorado, 81501, United States

Location

Yale University School Of Medicine

New Haven, Connecticut, 06520, United States

Location

Local Institution - 0147

Washington D.C., District of Columbia, 20007, United States

Location

Local Institution - 0011

Boynton Beach, Florida, 33426, United States

Location

Florida Cancer Specialists S.

Fort Myers, Florida, 33916, United States

Location

Local Institution - 0114

Hollywood, Florida, 33021, United States

Location

Cancer Specialists of North FL

Jacksonville, Florida, 32256, United States

Location

Local Institution - 0082

Pensacola, Florida, 32504, United States

Location

Local Institution - 0126

St. Petersburg, Florida, 33705, United States

Location

Local Institution - 0130

Tallahassee, Florida, 32308, United States

Location

Local Institution - 0125

West Palm Beach, Florida, 33401, United States

Location

Local Institution - 0119

Athens, Georgia, 30607, United States

Location

Local Institution - 0009

Atlanta, Georgia, 30318, United States

Location

Local Institution - 0024

Atlanta, Georgia, 30322, United States

Location

Augusta University

Augusta, Georgia, 30912, United States

Location

Local Institution - 0035

Chicago, Illinois, 60612, United States

Location

Local Institution - 0111

Fort Wayne, Indiana, 46845, United States

Location

Indiana University Cancer Ctr

Indianapolis, Indiana, 46202, United States

Location

Local Institution - 0018

Bethesda, Maryland, 20817, United States

Location

Local Institution - 0006

Baltimore, Massachusetts, 21229, United States

Location

Local Institution - 0123

Worcester, Massachusetts, 01655, United States

Location

Local Institution - 0150

Ypsilanti, Michigan, 48197, United States

Location

Local Institution - 0137

Hattiesburg, Mississippi, 39401, United States

Location

St. Louis Cancer Care, Llp

Bridgeton, Missouri, 63044, United States

Location

Local Institution - 0128

Kansas City, Missouri, 64132, United States

Location

Local Institution - 0049

Springfield, Missouri, 65806, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Local Institution - 0079

Lincoln, Nebraska, 68510, United States

Location

Local Institution - 0076

Flemington, New Jersey, 08822, United States

Location

Local Institution - 0002

Hackensack, New Jersey, 07601, United States

Location

Local Institution - 0095

New Brunswick, New Jersey, 08903, United States

Location

Local Institution - 0142

Paramus, New Jersey, 07652, United States

Location

Local Institution - 0010

Buffalo, New York, 14263, United States

Location

Broome Oncology LLC

Johnson City, New York, 13790, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Local Institution - 0017

New York, New York, 10065, United States

Location

Local Institution - 0001

Durham, North Carolina, 27710, United States

Location

Local Institution - 0096

Winston-Salem, North Carolina, 27157, United States

Location

Local Institution - 0012

Columbus, Ohio, 43219, United States

Location

University Of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

Location

Local Institution - 0145

Portland, Oregon, 97213, United States

Location

Local Institution - 0136

Lancaster, Pennsylvania, 17604, United States

Location

Local Institution - 0021

Philadelphia, Pennsylvania, 19104, United States

Location

Local Institution - 0036

Sayre, Pennsylvania, 18840, United States

Location

Local Institution - 0152

Greenville, South Carolina, 29605, United States

Location

Local Institution - 0069

Germantown, Tennessee, 38138, United States

Location

Tennessee Oncology, PLLC - SCRI - PPDS

Nashville, Tennessee, 37203, United States

Location

Baylor Research Institute

Dallas, Texas, 75246, United States

Location

Local Institution - 0044

Houston, Texas, 77090, United States

Location

Local Institution - 0037

San Antonio, Texas, 78229, United States

Location

Local Institution - 0046

Temple, Texas, 76508-0001, United States

Location

Local Institution - 0022

Ogden, Utah, 84403, United States

Location

Local Institution - 0153

Salt Lake City, Utah, 84106, United States

Location

Emily Couric Clinical Cancer Center

Charlottesville, Virginia, 22908, United States

Location

Virginia Cancer Institute

Richmond, Virginia, 23230, United States

Location

Local Institution - 0144

Seattle, Washington, 98108, United States

Location

Local Institution - 0029

Linz, 4020, Austria

Location

Universitaetsklinik Salzburg

Salzburg, 5020, Austria

Location

Local Institution - 0026

Vienna, 1090, Austria

Location

Wilhelminenspital

Vienna, 1160, Austria

Location

Klinikum Wels-Grieskirchen Gmbh

Wels, 4600, Austria

Location

Local Institution

Edmonton, Alberta, T6G 1Z2, Canada

Location

Local Institution

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Local Institution - 0074

Toronto, Ontario, M5G 2M9, Canada

Location

Local Institution - 0039

Montreal, Quebec, H2X 3E4, Canada

Location

MUHC - Glen Site

Montreal, Quebec, H4A 3J1, Canada

Location

Local Institution - 0154

Montreal, Quebec, H4J 1C5, Canada

Location

Local Institution

Québec, Quebec, G1R 2J6, Canada

Location

Local Institution - 0157

Rimouski, Quebec, G5L 5T1, Canada

Location

Interni hematologicka a onkologicka klinika

Brno, 625 00, Czechia

Location

Klinika hematoonkologie

Ostrava-Poruba, 708 52, Czechia

Location

I. interni klinika - klinika hematologie 1. LF UK a VFN v Praze

Prague, 128 08, Czechia

Location

Local Institution

Aarhus, 8200, Denmark

Location

Local Institution

Odense, 5000, Denmark

Location

Local Institution - 0050

Berlin, 12200, Germany

Location

Universitaetsklinikum Carl Gustav Carus

Dresden, 01307, Germany

Location

Uniklinikum Duesseldorf

Düsseldorf, 40225, Germany

Location

Local Institution - 0135

Kiel, 24105, Germany

Location

Klinikum Der Johannes Gutenberg Universitaet Mainz

Mainz, 55101, Germany

Location

Local Institution - 0054

Ulm, 89081, Germany

Location

Alexandra General Hospital Of Athens

Athens, 11528, Greece

Location

Local Institution - 0087

Beersheba, 84101, Israel

Location

Local Institution

Jerusalem, 9112001, Israel

Location

Local Institution

Petah Tikva, 4941492, Israel

Location

Local Institution

Ramat Gan, 52621, Israel

Location

Local Institution

Tel Aviv, 64239, Israel

Location

Local Institution - 0042

Turin, Piedmont, 10126, Italy

Location

Azienda Ospedaliero Universitaria Ospedali Riuniti Di Ancona

Ancona, 60126, Italy

Location

Local Institution - 0089

Bergamo, 24127, Italy

Location

A. O. U. Di Bologna, Policlinico S. Orsola Malpighi

Bologna, 40138, Italy

Location

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

Meldola (FC), 47014, Italy

Location

Azienda Ospedaliera Santa Maria Terni

Terni, 05100, Italy

Location

Local Institution

Oslo, 0372, Norway

Location

Local Institution - 0075

Stavanger, 4011, Norway

Location

Local Institution - 0132

Lisbon, Lisbon District, 1400-038, Portugal

Location

Local Institution

Porto, 4200-072, Portugal

Location

Local Institution - 0071

San Juan, 00918, Puerto Rico

Location

Local Institution - 0101

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

Local Institution - 0098

Badalona-Barcelona, 08916, Spain

Location

Local Institution - 0100

Barcelona, 08035, Spain

Location

Local Institution - 0097

Pamplona, 31008, Spain

Location

Local Institution - 0099

Salamanca, 37007, Spain

Location

Local Institution - 0064

Huddinge, 14186, Sweden

Location

Hopitaux Universitaires de Geneve

Geneva, 1211, Switzerland

Location

Local Institution - 0186

Istanbul, 34899, Turkey (Türkiye)

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Nivolumab; elotuzumab; pomalidomide; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Limitations and Caveats

Due to the early enrolment termination to Study CA209602 and the smaller than planned study sample size, the statistical analyses were not sufficiently powered.

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2016
• First Posted: April 1, 2016
• Study Start: August 10, 2016
• Primary Completion: March 9, 2022
• Study Completion: March 9, 2022
• Last Updated: March 27, 2023
• Results First Posted: March 27, 2023

Record last verified: 2023-02

Locations

NO (2); PT (2); PR (1); IL (5); US (72); CZ (3); IT (6); CH (1); ES (5); AU (5); SE (1); DE (6); CA (8); DK (2); TU (1); GR (1)