Safety and Efficacy of Pomalidomide, Bortezomib and Low-dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

Multiple Myeloma Clinical Trial

— OPTIMISMM  

Official title:

A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide, Bortezomib and Low-Dose Dexamethasone Versus Bortezomib and Low-Dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01734928
• Other study ID #: CC-4047-MM-007
• Status: Completed
• Phase: Phase 3
• Start date: January 7, 2013
• Est. completion date: May 13, 2022

Study information

• Verified date: May 2023
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the efficacy of the combination of pomalidomide, bortezomib and low dose dexamethasone to the combination of bortezomib and low dose dexamethasone in participants with relapsed/refractory multiple myeloma. This study will also assess how safe the combination of pomalidomide, bortezomib and low dose dexamethasone is compared to the combination of bortezomib and low dose dexamethasone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 559
• Est. completion date: May 13, 2022
• Est. primary completion date: May 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must be = 18 years at the time of signing informed consent.
• Must have documented diagnosis of multiple myeloma and have measureable disease by serum and urine protein electrophoresis.
• Must have had at least 1 but no greater than 3 prior anti-myeloma regimens.
• Must have documented disease progression during or after their last anti-myeloma therapy.
• All subjects must have received prior treatment with a lenalidomide containing regimen for at least 2 consecutive cycles.

Exclusion Criteria:

• Documented progressive disease during therapy or within 60 days of the last dose of a bortezomib-containing therapy under the 1.3 mg/m^2 dose twice weekly dosing schedule.
• Peripheral neuropathy Grade 3, Grade 4 or Grade 2 with pain within 14 days prior to randomization.
• Non-secretory multiple myeloma.
• Subjects with severe renal impairment requiring dialysis.
• Previous therapy with pomalidomide.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Pomalidomide
Pomalidomide 4 mg will be taken orally on Days 1-14 of a 21-day cycle.
• Bortezomib
Bortezomib 1.3 mg/m2 will be administered subcutaneously on Days 1, 4, 8 and 11 of 21 days for cycles 1 -8 and on Days 1, 8 of 21 days for cycle 9 and onward until disease progression.
• Dexamethasone
Dexamethasone 20 mg/day [= 75 years old] or 10 mg/day [>75 years old] will be taken orally on Days 1, 2, 4, 5, 8, 9, 11, 12 of 21 days for cycles 1-8 and on Days 1, 2, 8, 9 of 21 days for cycles 9 and onward until disease progression.

Locations

Country	Name	City	State
Austria	Hospital St. Polten	St. Pölten
Austria	Local Institution - 523	St. Pölten
Austria	Local Institution - 480	Vienna
Austria	Local Institution - 481	Vienna
Austria	Medical University of Vienna	Vienna
Austria	Wilhelminenspital-Center for Hematology and Oncology	Vienna
Canada	CSSS Champlain Charles LeMoyne	Greenfield Park	Quebec
Canada	Local Institution - 301	Greenfield Park	Quebec
Canada	Local Institution - 304	Halifax
Canada	Queen Elizabeth II Health Sciences Centre	Halifax
Canada	Local Institution - 308	Oshawa	Ontario
Canada	RSM Durham Regional Cancer Center - Lakeridge Health Oshawa	Oshawa	Ontario
Canada	Centre De Sante Et De Services Sociaux De Rimouski-Neigette	Rimouski	Quebec
Canada	Centre Hospitalier Universitaire de Sherbrooke-Hospital Fleurimont	Sherbrooke	Quebec
Canada	Local Institution - 307	Sherbrooke	Quebec
Denmark	Aarhus University Hospital	Aarhus
Denmark	Local Institution - 447	Aarhus
Denmark	Copenhagen University Hospital Rigshosptalet	Copenhagen
Denmark	Local Institution - 506	Copenhagen
Denmark	Local Institution - 400	Odense
Denmark	Odense University Hospital	Odense
Denmark	Local Institution - 499	Vejle
Denmark	Vejle Hospital	Vejle
Finland	Helsinki University Central Hospital	Helsinki
Finland	Local Institution - 455	Helsinki
Finland	Hyvinkaa Hospital	Hyvinkaa
Finland	Local Institution - 510	Hyvinkaa
France	Centre Hospitalier de la cote basque	Bayonne
France	Local Institution - 469	Bayonne
France	Centre Hospitalier William Morey	Chalon sur Saone
France	Local Institution - 498	Chalon sur Saone
France	CHU Hotel	Grenoble Cedex 09
France	Local Institution - 483	Grenoble Cedex 09
France	CHRU de Lille-Hopital Claude Huriez	Lille
France	GH Institut Catholique St Vincent	Lille
France	Local Institution - 476	Lille
France	CHRU Hotel Dieu	Nantes
France	Local Institution - 486	Nantes
France	Groupement Hospitalier Universitaire Est - Hopital Saint-Antoine	Paris
France	Centre Hospitalier Lyon Sud	Pierre-Bénite Cedex
France	Local Institution - 497	Pierre-Bénite Cedex
France	CHU La Miletrie	Poitiers Cedex
France	Local Institution - 516	Poitiers Cedex
France	CHRU Rennes	Rennes
France	Local Institution - 504	Rennes
France	Institut Universitaire du Cancer de Toulouse (IUCT) - Oncopole	Toulouse Cedex
France	CHRU Hopital Bretonneau	Tours cedex
France	Local Institution - 468	Tours cedex
Germany	ChariteUniversitatsmedizinCampus Benjamin Franklin	Berlin
Germany	Local Institution - 442	Berlin
Germany	Local Institution - 417	Dresden
Germany	Universitaetsklinikum Carl Gustav Carus	Dresden
Germany	Local Institution - 475	Essen
Germany	Universitaetsklinikum EssenInnere Klinik und Poliklinik	Essen
Germany	Local Institution - 496	Freiburg
Germany	Universitatsklinikum Freiburg	Freiburg
Germany	Local Institution - 430	Heidelberg
Germany	University of Heidelberg	Heidelberg
Germany	Local Institution - 410	Tuebingen
Germany	UKT Universitaetsklinikum Tuebingen	Tuebingen
Greece	General Hospital of Athens Evangelismos	Athens
Greece	Local Institution - 422	Athens
Greece	Local Institution - 484	Athens
Greece	University of Athens Medical school - Regional General Hospital	Athens
Greece	Local Institution - 487	Mezourlo
Greece	University General Hospital of Larissa	Mezourlo
Greece	George Papanikolaou General Hospital of Thessaloniki	Thessloniki
Greece	Local Institution - 465	Thessloniki
Ireland	Local Institution - 431	Dublin
Ireland	Local Institution - 462	Dublin
Ireland	Mater Misericordiae University Hospital	Dublin
Ireland	St James Hospital	Dublin
Ireland	Local Institution - 413	Galway
Ireland	University College Hospital Galway	Galway
Israel	Rambam Health Care Campus	Haifa
Israel	Hadassah Medical Center	Jerusalem
Israel	Local Institution - 457	Jerusalem
Israel	Local Institution - 433	Kfar-Saba
Israel	Meir Medical Center	Kfar-Saba
Israel	Chaim Sheba Medical Center	Ramat Gan
Israel	Tel Aviv Sourasky Medical Center Department of Hematology	Tel Aviv
Italy	Local Institution - 449	Bergamo
Italy	USC Ematologia, Azienda Ospedaliera Papa Giovanni XXIII	Bergamo
Italy	Local Institution - 456	Bologna
Italy	Policlinico S. Orsola - Malpighi	Bologna
Italy	Local Institution - 415	Catania
Italy	Ospedale Ferrarotto	Catania
Italy	Local Institution - 403	Modena
Italy	University of Modena	Modena
Italy	IRCCS Policlinico San Matteo	Pavia
Italy	Local Institution - 451	Pavia
Italy	Azienda Unita Sanitaria Locale (Ausl) Pescara - Presidio Ospedaliero Di Pescara	Pescara
Italy	Local Institution - 441	Pescara
Italy	Azienda Ospedaliera di Reggio Emilia - Arcispedale Santa Maria Nuova	Reggio Emilia
Italy	Local Institution - 414	Reggio Emilia
Italy	La Sapienza, University of Rome	Rome
Italy	Local Institution - 460	Rome
Italy	A.O.U.S. Giovanni e Ruggi d'Aragona UOC UTIC	Salerno
Italy	Local Institution - 459	Salerno
Italy	IRCCS Casa Sollievo della Sofferenza	San Giovanni Rotondo
Italy	Local Institution - 453	San Giovanni Rotondo
Italy	Azienda Ospedaliera S Maria di Terni	Terni
Italy	Local Institution - 402	Terni
Italy	Azienda Ospedaliera San Giovanni Battista	Torino
Italy	Local Institution - 401	Torino
Japan	Hitachi General Hospital	Hitachi, Ibaraki
Japan	Local Institution - 620	Hitachi, Ibaraki
Japan	Kameda Medical Center	Kamogawa
Japan	Local Institution - 625	Kamogawa
Japan	Local Institution - 626	Okayama
Japan	Okayama Medical Center	Okayama
Japan	Japan Red Cross Medical Center	Shibuya-ku
Japan	Local Institution - 623	Shibuya-ku
Japan	Local Institution - 622	Tachikawa
Japan	National Hospital Organization Disaster Medical Center	Tachikawa
Netherlands	Local Institution - 514	Groningen
Netherlands	Universitair Medisch Centrum Groningen	Groningen
Netherlands	Medisch Centrum Leeuwarden	Leeuwarden
Netherlands	Erasmus Medical Center	Rotterdam
Netherlands	Local Institution - 494	Rotterdam
Norway	Local Institution - 412	Oslo
Norway	Oslo universitetssykehus, Rikshospitalet	Oslo
Norway	St Olavs Hospital	Trondheim
Poland	Local Institution - 411	Brzozow
Poland	Szpital Specjalistyczny w Brzozowie	Brzozow
Poland	Szpital Uniwersytecki nr 2 im dr. Jana Biziela	Bydgoszcz
Poland	Local Institution - 407	Chorzow
Poland	Zespol Szpitali Miejskich	Chorzow
Poland	Klinika Hematologii Akademii Medycznej w Gdansku	Gdansk
Poland	Local Institution - 463	Gdansk
Poland	Local Institution - 440	Krakow
Poland	Oddzial Kliniczny Kliniki Hematologii	Krakow
Poland	Kopernik Memorial Hospital	Lodz
Poland	Local Institution - 418	Lodz
Poland	Klinika Hematoonkologii i Transplantacji Szpiku	Lublin
Poland	Local Institution - 439	Lublin
Poland	Local Institution - 437	Poznan
Poland	Oddzial Hematologii i Chorob Rozrostowych Ukladu Krwiotworczego	Poznan
Poland	Centrum Onkologii-Instytut im.Marii Sklodowskiej-Curie	Warszawa
Poland	Local Institution - 448	Warszawa
Portugal	Hospital de Braga	Braga
Portugal	Local Institution - 450	Braga
Portugal	Hospital de Santa Maria	Lisboa
Portugal	Instituto Portugues de Oncologia de Lisboa, Francisco Gentil	Lisboa
Portugal	Local Institution - 454	Lisboa
Portugal	Local Institution - 466	Lisboa
Portugal	Fundacao Champalimaud	Lisbon
Portugal	Local Institution - 473	Lisbon
Portugal	Hospital de Santo Antonio- Porto	Porto
Portugal	Instituto Portugues de Oncologia do Porto, Francisco Gentil	Porto
Portugal	Local Institution - 425	Porto
Portugal	Local Institution - 464	Porto
Puerto Rico	Ad-Vance Medical Research, LLC	Ponce
Russian Federation	City Clinical Hospital 52	Moscow
Russian Federation	Local Institution - 517	Moscow
Russian Federation	Local Institution - 521	Moscow
Russian Federation	Moscow State Healthcare Institution City clinical hospital n.a. S.P.Botkin	Moscow
Russian Federation	Local Institution - 520	Nizhny Novgorod
Russian Federation	State Budgetary Healthcare Institution of Nizhniy Novgorod Region	Nizhny Novgorod
Russian Federation	Russian Research Institute of Hematology and Transfusiology of the Federal Biomedical Agency	Saint Petersburg
Spain	Hospital Universitari Germans Trias i Pujol Can Ruti	Badalona (Barcelona)
Spain	Local Institution - 423	Badalona (Barcelona)
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Local Institution - 424	Barcelona
Spain	Hospital de Basurto-Osakidetza	Bilbao
Spain	Hospital 12 de Octubre	Madrid
Spain	Local Institution - 452	Madrid
Spain	Hospital Morales Meseguer	Murcia
Spain	Local Institution - 502	Murcia
Spain	Complejo Hospitalario De Orense	Orense
Spain	Local Institution - 526	Orense
Spain	Clinica Universidad de Navarra	Pamplona
Spain	Local Institution - 434	Pamplona
Spain	Complejo Hospitalario Nuestra Senora de Valme	Sevilla
Spain	Local Institution - 492	Sevilla
Spain	Hospital Universitario y Politecnico La Fe	Valencia
Sweden	Falu lasarett	Falun
Sweden	Local Institution - 426	Falun
Sweden	Local Institution - 478	Gothenburg
Sweden	Sahlgrenska University Hospital	Gothenburg
Sweden	Local Institution - 429	Luleå
Sweden	Sunderby Sjukhus	Luleå
Sweden	Karolinska University	Stockholm
Sweden	Local Institution - 471	Stockholm
Sweden	Sundsvalls sjukhus- Medicinkliniken	Sundsvall
Turkey	Ankara Universitesi Tip Fakultesi	Ankara
Turkey	Ankara University Medical Faculty Cebeci Hospital	Ankara
Turkey	Gazi Universitesi Tip Fakultesi Hastanesi	Ankara
Turkey	Local Institution - 408	Ankara
Turkey	Local Institution - 409	Ankara
Turkey	Local Institution - 428	Ankara
Turkey	Local Institution - 488	Antalya
Turkey	Medstar Antalya Hospital	Antalya
Turkey	Eskisehir Osmangazi University	Eskisehir
Turkey	Local Institution - 420	Eskisehir
Turkey	Gaziantep University	Gaziantep
Turkey	Local Institution - 421	Gaziantep
Turkey	Istanbul Universitesi Cerrahpasa Tip Fakultesi	Istanbul
Turkey	Istanbul University Faculty of Medicine	Istanbul
Turkey	Local Institution - 445	Istanbul
Turkey	Local Institution - 474	Istanbul
Turkey	Ege University Medical School	Izmir
Turkey	Local Institution - 419	Izmir
Turkey	Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi	Trabzon
Turkey	Local Institution - 404	Trabzon
United Kingdom	The Royal Bournemouth Hospital	Bournemouth
United Kingdom	Kent and Canterbury Hospital	Canterbury Kent
United Kingdom	Local Institution - 479	Canterbury Kent
United Kingdom	Local Institution - 406	Edinburgh Scotland
United Kingdom	Western General Hospital	Edinburgh Scotland
United Kingdom	Kings College Hospital	London
United Kingdom	Local Institution - 461	London
United Kingdom	Local Institution - 490	London
United Kingdom	University College London Hospitals	London
United Kingdom	Local Institution - 512	Oxford
United Kingdom	University of Oxford	Oxford
United Kingdom	Derriford Hospital Plymouth Oncology Centre Clinical Trials Unit	Plymouth
United Kingdom	Local Institution - 515	Plymouth
United Kingdom	Local Institution - 500	Sheffield
United Kingdom	Sheffield Teaching Hospitals NHS Foundation Trust - Royal Hallamshire Hospital	Sheffield
United Kingdom	Local Institution - 493	Southampton
United Kingdom	Southampton General Hospital	Southampton
United Kingdom	University Hospital of North Staffordshire Nhs Trust - City General Hospital	Stoke-On-Trent
United Kingdom	Local Institution - 405	Swansea
United Kingdom	Singleton Hospital	Swansea
United Kingdom	Local Institution - 482	Wolverhampton
United Kingdom	New Cross Hospital	Wolverhampton
United Kingdom	Local Institution - 436	Worcester
United Kingdom	Worcestershire Acute Hospitals NHS Trust	Worcester
United States	University of Colorado Cancer Center	Aurora	Colorado
United States	St. Agnes - Medical Center	Baltimore	Maryland
United States	Cancer Care of Maine	Bangor	Maine
United States	Local Institution - 132	Bangor	Maine
United States	Alta Bates Comprehensive Cancer Center	Berkeley	California
United States	Center for Cancer and Blood Disorders	Bethesda	Maryland
United States	Local Institution - 125	Bethesda	Maryland
United States	Billings Clinic	Billings	Montana
United States	Lynn Cancer Institute	Boca Raton	Florida
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Local Institution - 100	Boston	Massachusetts
United States	Local Institution - 298	Boston	Massachusetts
United States	Local Institution - 299	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University Cancer Institute	Boynton Beach	Florida
United States	Local Institution - 186	Bronx	New York
United States	Montefiore Medical Center	Bronx	New York
United States	Gabrail Cancer Center Research	Canton	Ohio
United States	Local Institution - 111	Canton	Ohio
United States	Med Univ of South Carolina	Charleston	South Carolina
United States	University of Chicago	Chicago	Illinois
United States	MetroHealth Medical Systems	Cleveland	Ohio
United States	Mid Ohio Oncology Hematology Inc	Columbus	Ohio
United States	Local Institution - 114	Dallas	Texas
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Henry Ford Medical Center - New Center One	Detroit	Michigan
United States	Local Institution - 178	Detroit	Michigan
United States	Essentia Health Duluth CCOP	Duluth	Minnesota
United States	Broward Oncology Assoc.	Fort Lauderdale	Florida
United States	Broward Oncology Associates PA	Fort Lauderdale	Florida
United States	Brooke Army Medical Center Francis Street Medical Center	Fort Sam Houston	Texas
United States	Local Institution - 103	Fort Sam Houston	Texas
United States	University of California San Francisco Fresno Campus	Fresno	California
United States	University of Florida	Gainesville	Florida
United States	Cancer and Hematology Centers of Western Michigan	Grand Rapids	Michigan
United States	Marin Oncology Associates	Greenbrae	California
United States	Eastern Institute of Medical Sciences	Greenville	North Carolina
United States	Alves Domenech Oncology and Hematology Clinic	Hollywood	Florida
United States	Local Institution - 130	Houston	Texas
United States	Northwest Cancer Center	Houston	Texas
United States	Medstar Health Research Institute	Hyattsville	Maryland
United States	Investigative Clinical Research of Indiana, LLC	Indianapolis	Indiana
United States	University of Iowa	Iowa City	Iowa
United States	Columbia Comprehensive	Jefferson City	Missouri
United States	CarePoint Health Research Institute	Jersey City	New Jersey
United States	Kansas City VA Medical Center University of Kansas Medical Center	Kansas City	Missouri
United States	University of Tennessee Medical Center - Cancer Institute	Knoxville	Tennessee
United States	Moore UCSD Cancer Center	La Jolla	California
United States	Detroit Clinical Research Center	Lansing	Michigan
United States	Southeast Nebraska Cancer Center	Lincoln	Nebraska
United States	USC Norris Comprehensive Cancer Center	Los Angeles	California
United States	Joe Arrington Cancer Research and Treatment Center	Lubbock	Texas
United States	University of Wisconsin	Madison	Wisconsin
United States	Local Institution - 135	Marietta	Georgia
United States	Northwest Georgia Oncology Centers, PCWilliam S. Gibbons Center Research Institute	Marietta	Georgia
United States	Local Institution - 136	Milwaukee	Wisconsin
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Southern Cancer Center	Mobile	Alabama
United States	Local Institution - 139	Morgantown	West Virginia
United States	West Virginia University CTRU	Morgantown	West Virginia
United States	Hematology-Oncology Associates of NNJ, P	Morristown	New Jersey
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Tulane University Medical Center	New Orleans	Louisiana
United States	Mount Sinai Hospital	New York	New York
United States	Western Kentucky Hematology and Oncology Group, PSC	Paducah	Kentucky
United States	Providence Portland Medical Center	Portland	Oregon
United States	Boice-Willis Clinic P.A.	Rocky Mount	North Carolina
United States	Beaumont Cancer Center	Royal Oak	Michigan
United States	St John's Mercy Medical Center	Saint Louis	Missouri
United States	Metro MN CCOP	Saint Louis Park	Minnesota
United States	Huntsman Cancer Institute at the University of Utah	Salt Lake City	Utah
United States	Utah Cancer Specialist	Salt Lake City	Utah
United States	Sutter Pacific Medical Foundation	Santa Rosa	California
United States	Swedish Cancer Inst	Seattle	Washington
United States	Avera Research Institute	Sioux Falls	South Dakota
United States	Somerset Hematology-Oncology Associates	Somerville	New Jersey
United States	Cancer Center of Central Connecticut	Southington	Connecticut
United States	Local Institution - 153	Southington	Connecticut
United States	Spartanburg Regional Healthcare System - Gibbs Cancer Center & Research Institute	Spartanburg	South Carolina
United States	Medical Oncology Associates	Spokane	Washington
United States	St. John's Clinic Cancerand Hematology - Springfield	Springfield	Missouri
United States	Stony Brook University	Stony Brook	New York
United States	University of Toledo Medical Center	Toledo	Ohio
United States	Arizona Oncology	Tucson	Arizona
United States	University of Arizona Cancer Center	Tucson	Arizona
United States	New York Medical College	Valhalla	New York
United States	George Washington Medical Center	Washington	District of Columbia
United States	Local Institution - 167	Watertown	South Dakota
United States	Prairie Lakes Health Care System	Watertown	South Dakota
United States	Wenatchee Valley Hospital and Clinics	Wenatchee	Washington
United States	Palm Beach Cancer Institute, LLC	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Countries where clinical trial is conducted

United States,  Austria,  Canada,  Denmark,  Finland,  France,  Germany,  Greece,  Ireland,  Israel,  Italy,  Japan,  Netherlands,  Norway,  Poland,  Portugal,  Puerto Rico,  Russian Federation,  Spain,  Sweden,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival by Independent Response Adjudication Committee (IRAC)	Progression free survival (PFS) will be calculated as the time between the randomization and progressive disease (PD) or death.; Progressive Disease is defined as an Increase of = 25% from nadir in: Serum M-component and/or (the absolute increase must be = 0.5 g/dL)g; Urine M-component and/or (the absolute increase must be = 200 mg/24 hours); In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels, the absolute increase must be > 100 mg/dL.; Bone marrow plasma cell percentage, the absolute % must be = 10%h; Definite development of new bone lesions or soft tissue plasmacytomas increase in the size of existing bone lesions or soft tissue plasmacytomas. -Development of hypercalcemia (corrected serum calcium > 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder.	From randomization to progressive disease or death during the IRAC assessment period, up to approximately 42 months
Secondary	Overall Survival (OS)	Overall survival (OS) is calculated as the time from randomization to death from any cause.	From randomization to date of death, up to approximately 65 months
Secondary	Overall Response Rate by Independent Response Adjudication Committee (IRAC)	The ORR together with the relative proportions in each response category (ie, stringent CR [sCR], CR, very good PR [VGPR], PR, SD, and PD) by treatment using the IMWG criteria will be examined.; Complete Response: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and = 5% plasma cells in bone marrow; SCR: CR+ Normal FLC ratio and Absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine Mprotein level < 100 mg per 24 hours; PR: = 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by = 90% or to < 200 mg per 24 hours; Progressive Disease: Please refer to Primary outcome measure for definition; SD: Not meeting criteria for CR, VGPR, PR, or progressive disease	From randomization to progressive disease or death during the IRAC assessment period, up to approximately 42 months
Secondary	Duration of Response by Independent Response Adjudication Committee (IRAC)	Duration of myeloma response is defined as the duration from the time when the IMWG response criteria are first met for sCR or CR or VGPR or PR until the first date the response criteria are met for PD or until the subject died from any cause, whichever occurs first.; Complete Response: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and = 5% plasma cells in bone marrow; SCR: CR+ Normal FLC ratio and Absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine Mprotein level < 100 mg per 24 hours; PR: = 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by = 90% or to < 200 mg per 24 hours; Progressive Disease: Please refer to Primary outcome measure for definition; SD: Not meeting criteria for CR, VGPR, PR, or progressive disease	From randomization to progressive disease or death during the IRAC assessment period, up to approximately 42 months
Secondary	Number of Participants With Grade 3-4 Treatment Emergent Adverse Events (TEAE)	Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first dose date of the study treatment and within 28 days after the last dose date.	From first dose to 28 days after the last dose (up to approximately 44 months
Secondary	Number of Participants With Grade 5 Treatment Emergent Adverse Events (TEAE)	Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first dose date of the study treatment and within 28 days after the last dose date.	From first dose to 28 days after the last dose (up to approximately 44 months

External Links

•   BMS Clinical Trial Information
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