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Multiple MyelomaPhase 3CheckMate 602NCT02726581

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

A Phase 3 study testing Nivolumab, Elotuzumab and Pomalidomide in people with Multiple Myeloma, run by Bristol-Myers Squibb at 121 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Nivolumab, Elotuzumab and Pomalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
121 sitesin 16 countries
Study dates
10 Aug 2016to 9 Mar 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Solitary bone or extramedullary plasmacytoma disease only
  • Active plasma cell leukemia
  • Other protocol defined inclusion/exclusion criteria apply

Trial locations and contacts

121 sites in 16 countries.

121 sites in 16 countries

United States72 sites

  • Local Institution - 0119

    Athens, Georgia, 30607

  • Local Institution - 0009

    Atlanta, Georgia, 30318

  • Local Institution - 0024

    Atlanta, Georgia, 30322

  • Augusta University

    Augusta, Georgia, 30912

  • Local Institution - 0118

    Bakersfield, California, 93309

  • Local Institution - 0006

    Baltimore, Massachusetts, 21229

  • Local Institution - 0018

    Bethesda, Maryland, 20817

  • Local Institution - 0020

    Birmingham, Alabama, 35294-3300

  • Local Institution - 0011

    Boynton Beach, Florida, 33426

  • St. Louis Cancer Care, Llp

    Bridgeton, Missouri, 63044

  • Local Institution - 0010

    Buffalo, New York, 14263

  • Emily Couric Clinical Cancer Center

    Charlottesville, Virginia, 22908

  • Local Institution - 0035

    Chicago, Illinois, 60612

  • Local Institution - 0012

    Columbus, Ohio, 43219

  • Local Institution - 0093

    Corona, California, 92879

  • Baylor Research Institute

    Dallas, Texas, 75246

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

  • Local Institution - 0001

    Durham, North Carolina, 27710

  • Local Institution - 0163

    Fayetteville, Arkansas, 72703

  • Local Institution - 0076

    Flemington, New Jersey, 08822

  • Poudre Valley Health Care

    Fort Collins, Colorado, 80528

  • Florida Cancer Specialists S.

    Fort Myers, Florida, 33916

  • Local Institution - 0111

    Fort Wayne, Indiana, 46845

  • Local Institution - 0016

    Fountain Valley, California, 92708

  • Local Institution - 0069

    Germantown, Tennessee, 38138

  • Local Institution - 0116

    Grand Junction, Colorado, 81501

  • Local Institution - 0152

    Greenville, South Carolina, 29605

  • Local Institution - 0002

    Hackensack, New Jersey, 07601

  • Local Institution - 0137

    Hattiesburg, Mississippi, 39401

  • Local Institution - 0114

    Hollywood, Florida, 33021

  • Local Institution - 0044

    Houston, Texas, 77090

  • Indiana University Cancer Ctr

    Indianapolis, Indiana, 46202

  • Cancer Specialists of North FL

    Jacksonville, Florida, 32256

  • Broome Oncology LLC

    Johnson City, New York, 13790

  • Local Institution - 0128

    Kansas City, Missouri, 64132

  • Local Institution - 0164

    La Jolla, California, 92037

  • UC San Diego Moores Cancer Ctr

    La Jolla, California, 92093-0698

  • Local Institution - 0136

    Lancaster, Pennsylvania, 17604

  • Local Institution - 0079

    Lincoln, Nebraska, 68510

  • Local Institution - 0138

    Los Angeles, California, 90017

  • Local Institution - 0155

    Los Angeles, California, 90095

  • Local Institution - 0160

    Mobile, Alabama, 36608

  • Tennessee Oncology, PLLC - SCRI - PPDS

    Nashville, Tennessee, 37203

  • Local Institution - 0095

    New Brunswick, New Jersey, 08903

  • Yale University School Of Medicine

    New Haven, Connecticut, 06520

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Local Institution - 0017

    New York, New York, 10065

  • Local Institution - 0022

    Ogden, Utah, 84403

  • University Of Oklahoma

    Oklahoma City, Oklahoma, 73104

  • Local Institution - 0142

    Paramus, New Jersey, 07652

  • Local Institution - 0082

    Pensacola, Florida, 32504

  • Local Institution - 0021

    Philadelphia, Pennsylvania, 19104

  • Local Institution - 0145

    Portland, Oregon, 97213

  • Local Institution - 0117

    Redondo Beach, California, 90277

  • Virginia Cancer Institute

    Richmond, Virginia, 23230

  • Local Institution - 0092

    Riverside, California, 92501

  • Local Institution - 0153

    Salt Lake City, Utah, 84106

  • Local Institution - 0037

    San Antonio, Texas, 78229

  • Coastal Integrative Cancer Care

    San Luis Obispo, California, 93401

  • Local Institution - 0113

    Santa Maria, California, 93454

  • Local Institution - 0036

    Sayre, Pennsylvania, 18840

  • Local Institution - 0144

    Seattle, Washington, 98108

  • Local Institution - 0049

    Springfield, Missouri, 65806

  • Washington University

    St Louis, Missouri, 63110

  • Local Institution - 0126

    St. Petersburg, Florida, 33705

  • Local Institution - 0130

    Tallahassee, Florida, 32308

  • Local Institution - 0046

    Temple, Texas, 76508-0001

  • Local Institution - 0147

    Washington D.C., District of Columbia, 20007

  • Local Institution - 0125

    West Palm Beach, Florida, 33401

  • Local Institution - 0096

    Winston-Salem, North Carolina, 27157

  • Local Institution - 0123

    Worcester, Massachusetts, 01655

  • Local Institution - 0150

    Ypsilanti, Michigan, 48197

Other trials in United States

Canada8 sites

  • Local Institution

    Edmonton, Alberta, T6G 1Z2

  • Local Institution - 0039

    Montreal, Quebec, H2X 3E4

  • MUHC - Glen Site

    Montreal, Quebec, H4A 3J1

  • Local Institution - 0154

    Montreal, Quebec, H4J 1C5

  • Local Institution

    Québec, Quebec, G1R 2J6

  • Local Institution - 0157

    Rimouski, Quebec, G5L 5T1

  • Local Institution - 0074

    Toronto, Ontario, M5G 2M9

  • Local Institution

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Germany6 sites

  • Local Institution - 0050

    Berlin, 12200

  • Universitaetsklinikum Carl Gustav Carus

    Dresden, 01307

  • Uniklinikum Duesseldorf

    Düsseldorf, 40225

  • Local Institution - 0135

    Kiel, 24105

  • Klinikum Der Johannes Gutenberg Universitaet Mainz

    Mainz, 55101

  • Local Institution - 0054

    Ulm, 89081

Other trials in Germany

Italy6 sites

  • Azienda Ospedaliero Universitaria Ospedali Riuniti Di Ancona

    Ancona, 60126

  • Local Institution - 0089

    Bergamo, 24127

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

    Bologna, 40138

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

    Meldola (FC), 47014

  • Azienda Ospedaliera Santa Maria Terni

    Terni, 05100

  • Local Institution - 0042

    Turin, Piedmont, 10126

Other trials in Italy

Austria5 sites

  • Local Institution - 0029

    Linz, 4020

  • Universitaetsklinik Salzburg

    Salzburg, 5020

  • Local Institution - 0026

    Vienna, 1090

  • Wilhelminenspital

    Vienna, 1160

  • Klinikum Wels-Grieskirchen Gmbh

    Wels, 4600

Other trials in Austria

Israel5 sites

  • Local Institution - 0087

    Beersheba, 84101

  • Local Institution

    Jerusalem, 9112001

  • Local Institution

    Petah Tikva, 4941492

  • Local Institution

    Ramat Gan, 52621

  • Local Institution

    Tel Aviv, 64239

Other trials in Israel

Spain5 sites

  • Local Institution - 0098

    Badalona-Barcelona, 08916

  • Local Institution - 0100

    Barcelona, 08035

  • Local Institution - 0097

    Pamplona, 31008

  • Local Institution - 0101

    Pozuelo de Alarcón, Madrid, 28223

  • Local Institution - 0099

    Salamanca, 37007

Other trials in Spain

Czechia3 sites

  • Interni hematologicka a onkologicka klinika

    Brno, 625 00

  • Klinika hematoonkologie

    Ostrava-Poruba, 708 52

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

    Prague, 128 08

Other trials in Czechia

Denmark2 sites

  • Local Institution

    Aarhus, 8200

  • Local Institution

    Odense, 5000

Other trials in Denmark

Norway2 sites

  • Local Institution

    Oslo, 0372

  • Local Institution - 0075

    Stavanger, 4011

Other trials in Norway

Portugal2 sites

  • Local Institution - 0132

    Lisbon, Lisbon District, 1400-038

  • Local Institution

    Porto, 4200-072

Other trials in Portugal

Greece1 site

  • Alexandra General Hospital Of Athens

    Athens, 11528

Other trials in Greece

Puerto Rico1 site

  • Local Institution - 0071

    San Juan, 00918

Other trials in Puerto Rico

Sweden1 site

  • Local Institution - 0064

    Huddinge, 14186

Other trials in Sweden

Switzerland1 site

  • Hopitaux Universitaires de Geneve

    Geneva, 1211

Other trials in Switzerland

Turkey (Türkiye)1 site

  • Local Institution - 0186

    Istanbul, 34899

Other trials in Turkey (Türkiye)

About this study

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

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.

Being tested
Nivolumab, Elotuzumab, Pomalidomide, Dexamethasone
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NivolumabBiological

    Also called BMS-936558

    Specified dose on specified days, IV (intravenous)

  • ElotuzumabBiological

    Also called BMS-901608

    Specified dose on specified days, IV

  • PomalidomideDrug

    Specified dose on specified days, PO (by mouth)

  • DexamethasoneDrug

    Specified dose on specified days, PO

Study groups in NCT02726581
Study groupRoleWhat they receive
Investigational ArmExperimentalNivolumab, Pomalidomide and Dexamethasone Enrollment is closed for this arm
Receives: Biological: Nivolumab; Drug: Pomalidomide; Drug: Dexamethasone
Control ArmActive comparatorPomalidomide and Dexamethasone Enrollment is closed for this arm
Receives: Drug: Pomalidomide; Drug: Dexamethasone
Exploratory ArmExperimentalNivolumab, Elotuzumab, Pomalidomide and Dexamethasone Enrollment is closed for this arm
Receives: Biological: Nivolumab; Biological: Elotuzumab; Drug: Pomalidomide; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. Overall Survival (OS)

    The time between the date of randomization and the date of death due to any cause. OS will be censored on the last date a participant was known to be alive.

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

  2. Objective Response Rate (ORR)

    The percentage of randomized participants who achieved a best overall response (BOR) of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) using International Myeloma Working Group (IMWG) criteria.

    sCR= Complete response as defined below plus normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry.

    CR = Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow aspirates.

    VGPR = Serum and urine M-protein detectable by immunofixation but not on electrophoresis or >/= 90% reduction in serum M-protein plus urine M-protein level < 100 mg per 24 h.

    PR = >/= 50% reduction of serum M-protein plus reduction in 24 h urinary M-protein by >/= 90% or to < 200 mg per 24 h.

    Measured: From randomization up to approximately 64 months

  3. Time to Objective Response (TTR)

    The time from the date of randomization to the date of the first stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR).

    sCR= Complete response as defined below plus normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry.

    CR = Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow aspirates.

    VGPR = Serum and urine M-protein detectable by immunofixation but not on electrophoresis or >/= 90% reduction in serum M-protein plus urine M-protein level < 100 mg per 24 h.

    PR = >/= 50% reduction of serum M-protein plus reduction in 24 h urinary M-protein by >/= 90% or to < 200 mg per 24 h.

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

  4. Duration of Objective Response (DOR)

    The time between the date of first response to the date of the first objectively documented tumor progression as assessed by the investigator according to International Myeloma Working Group (IMWG) criteria or death due to any cause prior to subsequent anti-cancer therapy. Participants who neither progress nor die will be censored on the date of their last tumor 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.

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2016 (estimated)
  2. Study start10 Aug 2016
  3. Primary completion9 Mar 2022
  4. Study completion9 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02726581
Sponsor's protocol ID
CA209-602
Other IDs
2015-005699-21, 2015
Acronym
CheckMate 602
Status last verified
Feb 2023
First submitted
23 Mar 2016
Last updated
27 Mar 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nivolumab, Elotuzumab and Pomalidomide in people with Multiple Myeloma, run by Bristol-Myers Squibb at 121 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 121 sites in United States, Canada, Germany, Italy, Austria and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02726581.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2023.

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