Multiple Myeloma Clinical Trial
— CheckMate 602Official title:
An Open-Label, Randomized Phase 3 Trial of Combinations of Nivolumab, Pomalidomide and Dexamethasone in Relapsed and Refractory Multiple Myeloma
| Verified date | February 2023 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 170 |
| Est. completion date | March 9, 2022 |
| Est. primary completion date | March 9, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Local Institution - 0029 | Linz | |
| Austria | Universitaetsklinik Salzburg | Salzburg | |
| Austria | Local Institution - 0026 | Vienna | |
| Austria | Klinikum Wels-Grieskirchen Gmbh | Wels | |
| Austria | Wilhelminenspital | Wien | |
| Canada | Local Institution | Edmonton | Alberta |
| Canada | Local Institution - 0039 | Montreal | Quebec |
| Canada | Local Institution - 0154 | Montreal | Quebec |
| Canada | MUHC - Glen Site | Montreal | Quebec |
| Canada | Local Institution | Quebec | |
| Canada | Local Institution - 0157 | Rimouski | Quebec |
| Canada | Local Institution - 0074 | Toronto | Ontario |
| Canada | Local Institution | Vancouver | British Columbia |
| Czechia | Interni hematologicka a onkologicka klinika | Brno | |
| Czechia | Klinika hematoonkologie | Ostrava-Poruba | |
| Czechia | I. interni klinika - klinika hematologie 1. LF UK a VFN v Praze | Praha 2 | |
| Denmark | Local Institution | Aarhus | |
| Denmark | Local Institution | Odense | |
| Germany | Local Institution - 0050 | Berlin | |
| Germany | Universitaetsklinikum Carl Gustav Carus | Dresden | |
| Germany | Uniklinikum Duesseldorf | Duesseldorf | |
| Germany | Local Institution - 0135 | Kiel | |
| Germany | Klinikum Der Johannes Gutenberg Universitaet Mainz | Mainz | |
| Germany | Local Institution - 0054 | Ulm | |
| Greece | Alexandra General Hospital Of Athens | Athens | |
| Israel | Local Institution - 0087 | Beer Sheva | |
| Israel | Local Institution | Jerusalem | |
| Israel | Local Institution | Petah Tikva | |
| Israel | Local Institution | Ramat-gan | |
| Israel | Local Institution | Tel Aviv | |
| Italy | Azienda Ospedaliero Universitaria Ospedali Riuniti Di Ancona | Ancona | |
| Italy | Local Institution - 0089 | Bergamo | |
| Italy | A. O. U. Di Bologna, Policlinico S. Orsola Malpighi | Bologna | |
| Italy | Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) | Meldola (FC) | |
| Italy | Azienda Ospedaliera Santa Maria Terni | Terni | |
| Italy | Local Institution - 0042 | Torino | Piemonte |
| Norway | Local Institution | Oslo | |
| Norway | Local Institution - 0075 | Stavanger | |
| Portugal | Local Institution - 0132 | Lisbon | Lisboa |
| Portugal | Local Institution | Porto | |
| Puerto Rico | Local Institution - 0071 | San Juan | |
| Spain | Local Institution - 0098 | Badalona-Barcelona | |
| Spain | Local Institution - 0100 | Barcelona | |
| Spain | Local Institution - 0097 | Pamplona | |
| Spain | Local Institution - 0101 | Pozuelo De Alarcon | Madrid |
| Spain | Local Institution - 0099 | Salamanca | |
| Sweden | Local Institution - 0064 | Huddinge | |
| Switzerland | Hopitaux Universitaires de Geneve | Geneve | |
| Turkey | Local Institution - 0186 | Istanbul | |
| United States | Local Institution - 0119 | Athens | Georgia |
| United States | Local Institution - 0009 | Atlanta | Georgia |
| United States | Local Institution - 0024 | Atlanta | Georgia |
| United States | Augusta University | Augusta | Georgia |
| United States | Local Institution - 0118 | Bakersfield | California |
| United States | Local Institution - 0006 | Baltimore | Massachusetts |
| United States | Local Institution - 0018 | Bethesda | Maryland |
| United States | Local Institution - 0020 | Birmingham | Alabama |
| United States | Local Institution - 0011 | Boynton Beach | Florida |
| United States | St. Louis Cancer Care, Llp | Bridgeton | Missouri |
| United States | Local Institution - 0010 | Buffalo | New York |
| United States | Emily Couric Clinical Cancer Center | Charlottesville | Virginia |
| United States | Local Institution - 0035 | Chicago | Illinois |
| United States | Local Institution - 0012 | Columbus | Ohio |
| United States | Local Institution - 0093 | Corona | California |
| United States | Baylor Research Institute | Dallas | Texas |
| United States | Colorado Blood Cancer Institute | Denver | Colorado |
| United States | Local Institution - 0001 | Durham | North Carolina |
| United States | Local Institution - 0163 | Fayetteville | Arkansas |
| United States | Local Institution - 0076 | Flemington | New Jersey |
| United States | Poudre Valley Health Care | Fort Collins | Colorado |
| United States | Florida Cancer Specialists S. | Fort Myers | Florida |
| United States | Local Institution - 0111 | Fort Wayne | Indiana |
| United States | Local Institution - 0016 | Fountain Valley | California |
| United States | Local Institution - 0069 | Germantown | Tennessee |
| United States | Local Institution - 0116 | Grand Junction | Colorado |
| United States | Local Institution - 0152 | Greenville | South Carolina |
| United States | Local Institution - 0002 | Hackensack | New Jersey |
| United States | Local Institution - 0137 | Hattiesburg | Mississippi |
| United States | Local Institution - 0114 | Hollywood | Florida |
| United States | Local Institution - 0044 | Houston | Texas |
| United States | Indiana University Cancer Ctr | Indianapolis | Indiana |
| United States | Cancer Specialists of North FL | Jacksonville | Florida |
| United States | Broome Oncology LLC | Johnson City | New York |
| United States | Local Institution - 0128 | Kansas City | Missouri |
| United States | Local Institution - 0164 | La Jolla | California |
| United States | UC San Diego Moores Cancer Ctr | La Jolla | California |
| United States | Local Institution - 0136 | Lancaster | Pennsylvania |
| United States | Local Institution - 0079 | Lincoln | Nebraska |
| United States | Local Institution - 0138 | Los Angeles | California |
| United States | Local Institution - 0155 | Los Angeles | California |
| United States | Local Institution - 0160 | Mobile | Alabama |
| United States | Tennessee Oncology, PLLC - SCRI - PPDS | Nashville | Tennessee |
| United States | Local Institution - 0095 | New Brunswick | New Jersey |
| United States | Yale University School Of Medicine | New Haven | Connecticut |
| United States | Local Institution - 0017 | New York | New York |
| United States | Mount Sinai Medical Center | New York | New York |
| United States | Local Institution - 0022 | Ogden | Utah |
| United States | University Of Oklahoma | Oklahoma City | Oklahoma |
| United States | Local Institution - 0142 | Paramus | New Jersey |
| United States | Local Institution - 0082 | Pensacola | Florida |
| United States | Local Institution - 0021 | Philadelphia | Pennsylvania |
| United States | Local Institution - 0145 | Portland | Oregon |
| United States | Local Institution - 0117 | Redondo Beach | California |
| United States | Virginia Cancer Institute | Richmond | Virginia |
| United States | Local Institution - 0092 | Riverside | California |
| United States | Washington University | Saint Louis | Missouri |
| United States | Local Institution - 0126 | Saint Petersburg | Florida |
| United States | Local Institution - 0153 | Salt Lake City | Utah |
| United States | Local Institution - 0037 | San Antonio | Texas |
| United States | Coastal Integrative Cancer Care | San Luis Obispo | California |
| United States | Local Institution - 0113 | Santa Maria | California |
| United States | Local Institution - 0036 | Sayre | Pennsylvania |
| United States | Local Institution - 0144 | Seattle | Washington |
| United States | Local Institution - 0049 | Springfield | Missouri |
| United States | Local Institution - 0130 | Tallahassee | Florida |
| United States | Local Institution - 0046 | Temple | Texas |
| United States | Local Institution - 0147 | Washington | District of Columbia |
| United States | Local Institution - 0125 | West Palm Beach | Florida |
| United States | Local Institution - 0096 | Winston-Salem | North Carolina |
| United States | Local Institution - 0123 | Worcester | Massachusetts |
| United States | Local Institution - 0150 | Ypsilanti | Michigan |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb | AbbVie |
United States, Austria, Canada, Czechia, Denmark, Germany, Greece, Israel, Italy, Norway, Portugal, Puerto Rico, Spain, Sweden, Switzerland, Turkey,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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. | From randomization to the date of death due to any cause (up to approximately 64 months) | |
| Secondary | 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. |
From randomization up to approximately 64 months | |
| Secondary | 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. |
From the date of randomization to the date of the first sCR, CR, VGPR, or PR (up to approximately 64 months) | |
| Secondary | 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. | 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) |
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