Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant

Multiple Myeloma Clinical Trial

— MagnetisMM-7  

Official title:

A RANDOMIZED, 2-ARM, PHASE 3 STUDY OF ELRANATAMAB (PF-06863135) VERSUS LENALIDOMIDE IN PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA AFTER UNDERGOING AUTOLOGOUS STEM-CELL TRANSPLANTATION

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05317416
• Other study ID #: C1071007
• Secondary ID: 2021-006052-14Ma
• Status: Recruiting
• Phase: Phase 3
• Start date: March 25, 2022
• Est. completion date: October 31, 2029

Study information

• Verified date: May 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate whether elranatamab monotherapy can provide clinical benefit compared to lenalidomide monotherapy (control) in participants with newly diagnosed multiple myeloma after undergoing autologous stem cell transplant. In Part 1 and Part 2 of the study, participants in the study will either receive elranatamab (arm A and C) as an injection under the skin at the study clinic or lenalidomide orally once daily at home (arm B). Participation in the study will be approximately five years

Description:

Elranatamab is a bispecific antibody: binding of elranatamab to CD3-expressing T-cells and BCMA-expressing multiple myeloma cells causes targeted T-cell-mediated cytotoxicity.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 760
• Est. completion date: October 31, 2029
• Est. primary completion date: August 4, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of MM as defined according to IMWG criteria (Rajkumar, 2014) with measurable disease at diagnosis

• Part 1 patients must be MRD positive, Part 2 patients can be MRD negative or MRD positive

• History of induction therapy for newly diagnosed MM, followed by high dose therapy and autologous stem cell transplant. Randomization must occur within 120 days from the stem cell transplant. For participants who receive consolidation therapy after ASCT, randomization must occur within 60 days of consolidation and within 7 months from ASCT.

• Partial Response or better according to IMWG criteria at the time of randomization

• Must have an archival bone marrow aspirate sample(s) to identify the dominant malignant (index) clone by central laboratory NGS test (ClonoSEQ assay) that is used to track MRD status. This sample should preferably be collected before induction treatment (eg, at diagnosis) or before transplant.

• ECOG performance status =1

• Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade = 1

• Not pregnant and willing to use contraception

Exclusion Criteria:

• Plasma cell leukemia

• Amyloidosis, Waldenström's macroglobulinemia

• POEMS syndrome

• Known active CNS involvement or clinical signs of myelomatous meningeal involvement

• Previous MM maintenance treatment

• Prior treatment with BCMA targeted therapy

• Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ

• Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) HBV, HCV, and known HIV or AIDS-related illness

• Previous administration with an investigational drug or vaccine within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Elranatamab
BCMA-CD3 bispecific antibody
• Lenalidomide
Immunomodulatory drug
• Lenalidomide
Immunomodulatory drug
• Elranatamab
BCMA-CD3 bispecific antibody

Locations

Country	Name	City	State
Australia	Pindara Private Hospital	Benowa	Queensland
Australia	QScan Radiology Clinics	Clayfield	Queensland
Australia	Epworth Healthcare	East Melbourne	Victoria
Australia	Precision Haematology	East Melbourne	Victoria
Australia	St Vincent's Hospital (Melbourne)	Fitzroy	Victoria
Australia	Slade Pharmacy	Richmond
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland
Austria	Hanusch-Krankenhaus	Vienna
Austria	Medizinische Universität Wien	Vienna	Wien
Austria	Medizinische Universität Wien	Wien
Belgium	Institut Jules Bordet	Anderlecht	Bruxelles-capitale, Région DE
Belgium	Zna Cadix	Antwerpen
Belgium	Zna Cadix	Antwerpen
Belgium	ZNA Middelheim	Antwerpen
Belgium	ZNA Stuivenberg	Antwerpen
Belgium	ZNA Stuivenberg	Antwerpen
Belgium	UZ Brussel	Brussel
Belgium	Grand Hôpital de Charleroi	Charleroi	Hainaut
Belgium	Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godi	Yvoir	Namur
Brazil	Ambulatório de QT Convênio	Jaú	SÃO Paulo
Brazil	Fundação Doutor Amaral Carvalho	Jaú
Brazil	Hospital Amaral Carvalho	Jaú	SÃO Paulo
Brazil	Centro de Pesquisa Clínica - Área Administrativa	Porto Alegre	RIO Grande DO SUL
Brazil	Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa	Porto Alegre	RIO Grande DO SUL
Brazil	Hospital Mae de Deus	Porto Alegre	RIO Grande DO SUL
Brazil	Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP	Ribeirão Preto	SÃO Paulo
Brazil	Américas Medical City	Rio de Janeiro
Brazil	Instituto de Educação, Pesquisa e Gestão em Saúde	Rio de Janeiro
Brazil	Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Salvador	Salvador,	Bahia
Brazil	BP - A Beneficencia Portuguesa de São Paulo	Sao Paulo	SÃO Paulo
Brazil	Clínica Médica São Germano S/S Ltda	São Paulo
Brazil	ESHO Empresa de Serviços Hospitalares S.A/ Hospital Samaritano de Higienópolis	São Paulo
Brazil	Hospital Japonês Santa Cruz	São Paulo
Brazil	HU UNIFESP / SPDM - Hospital São Paulo	São Paulo
Brazil	Universidade Federal de Sao Paulo	São Paulo
Brazil	Clínica Médica São Germano LTDA	SP	SÃO Paulo
Canada	Tom Baker Cancer Center	Calgary	Alberta
Canada	Dr. Everett Chalmers Regional Hospital	Fredericton	New Brunswick
Canada	Hamilton Health Sciences Corporation	Hamilton	Ontario
Canada	Centre Integre Universitaire de la Santé et de Services Sociaux de l'Est-de-l'ile-de-Montreal,	Montreal	Quebec
Canada	Centre intégré universitaire de santé et de services sociaux du Nord-de-l'Île-de-Montréal (CIUSS	Montreal	Quebec
Canada	McGill University Health Centre	Montreal	Quebec
Canada	Saint John Regional Hospital	Saint John	New Brunswick
Canada	Princess Margaret Cancer Centre	Toronto	Ontario
Canada	Windsor Regional Hospital Cancer Program	Windsor	Ontario
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	Shanghai Fourth People's Hospital	Shanghai
China	Institute of hematology&blood disease hospital	Tianjin	Tianjin
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
China	Tongji Hospital; Tongji Medical college; Huazhong University of Science and Technonogy	Wuhan	Hubei
Czechia	Fakultní nemocnice Brno Bohunice	Brno	Brno-mesto
Czechia	Fakultni nemocnice Hradec Kralove	Hradec Kralove	Hradec Králové
Czechia	Fakultni nemocnice Olomouc	Olomouc
Czechia	Fakultni nemocnice Ostrava	Ostrava	Moravskoslezský KRAJ
Czechia	Fakultni nemocnice Ostrava	Ostrava-Poruba	Moravskoslezský KRAJ
Czechia	Vseobecna fakultni nemocnice v Praze	Praha 2
Finland	Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)	Helsinki	Uusimaa
Finland	Oulun yliopistollinen sairaala	Oulu	Pohjois-pohjanmaa
Finland	Turku University Hospital	Turku	Varsinais-suomi
France	Chu Grenoble Alpes	La Tronche
France	Hopital Claude Huriez - CHU de Lille	Lille
France	Hopital Claude Huriez - CHU de Lille	Lille	Nord
France	Hôpital Saint Antoine	Paris	Île-de-france
France	Pitie Salpetriere University Hospital	Paris	Orne
France	Hôpital Saint Antoine	Paris Cedex 12
France	Hopital Lyon Sud	Pierre Benite
France	Centre Hospitalier Universitaire de Poitiers	Poitiers	Vienne
France	Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE	Toulouse	Haute-garonne
France	Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau	Tours
France	Gustave Roussy	Villejuif	Val-de-marne
Germany	Charite Universitätsmedizin Berlin Campus Benjamin Franklin	Berlin
Germany	Charite Universitätsmedizin Berlin Campus Benjamin Franklin	Berlin
Germany	Klinikum Chemnitz gGMbH	Chemnitz
Germany	Universitätsklinikum Essen	Essen
Germany	Universitaetsklinikum Schleswig-Holstein Campus Kiel	Kiel	Schleswig-holstein
Germany	Universitaetsklinikum Koeln	Köln	Nordrhein-westfalen
Germany	Universitätsklinikum Leipzig	Leipzig	Sachsen
Germany	Universitätsmedizin Johannes Gutenberg Universität Mainz	Mainz	Rheinland-pfalz
Germany	Klinikum rechts der Isar der Technischen Universität München	München
Germany	Universitätsklinikum Würzburg	Würzburg	Bayern
Greece	Alexandra General Hospital of Athens	Athens	Attikí
Greece	Evangelismos General Hospital of Athens	Athens	Attikí
Greece	Evangelismos Hospital	Athens
Greece	University Hospital of Ioannina	Ioannina	Ípeiros
Greece	Theageneio Cancer Hospital of Thessaloniki	Thessaloniki	Kentrikí Makedonía
Hungary	Dél-Pesti Centrumkórház	Budapest
Hungary	Semmelweis University	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont	Debrecen
Hungary	Somogy Megyei Kaposi Mór Oktató Kórház	Kaposvár	Somogy
Hungary	Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház, Jósa András Oktatókórház	Nyíregyháza
India	Himalayan Institute Hospital Trust University	Dehradun	Uttarakhand
India	Rajiv Gandhi Cancer Institute And Research Centre	Delhi
India	Artemis hospital	Gurugram	Haryana
India	Fortis Memorial Research Institute	Gurugram	Haryana
India	Medanta-The Medicity	Gurugram	Haryana
India	Tata Medical Center	Kolkata	WEST Bengal
India	Christian Medical College Vellore	Ranipet	Tamil NADU
Israel	Soroka Medical Center	Be'er Sheva	Hadarom
Israel	Rambam Health Care Campus	Haifa	Hatsafon
Israel	Hadassah Medical Center	Jerusalem	Yerushalayim
Israel	Hadassah Mount Scopus Medical Center	Jerusalem	Yerushalayim
Israel	Shaare Zedek Medical Center	Jerusalem
Israel	Shaare Zedek Medical Center	Jerusalem
Israel	Shaare Zedek Medical Center	Jerusalem	Yerushalayim
Israel	Rabin Medical Center	Petah-Tikva	Hamerkaz
Israel	Sheba Medical Center	Ramat Gan	Hamerkaz
Israel	Tel-Aviv Sourasky Medical Center Dana-Dwek Children's Hospital	Tel Aviv	Tell Abib
Italy	Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi	Ancona
Italy	IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola	Bologna
Italy	Policlinico "G. Rodolico"	Catania	Sicilia
Italy	IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"	Meldola	Emilia-romagna
Italy	Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico	Milano	Lombardia
Italy	AOU Policlinico Umberto I	Roma
Italy	Fondazione Policlinico Universitario Agostino Gemelli	Roma	Lazio
Italy	Azienda Ospedaliero Universitaria Senese	Siena	Toscana
Italy	Universita di Siena -Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle Scotte	Siena	Toscana
Japan	Hamamatsu University Hospital	Hamamatsu-shi	Shizuoka
Japan	National Hospital Organization Kumamoto Medical Center	Kumamoto
Japan	University Hospital,Kyoto Prefectural University of Medicine	Kyoto
Japan	University Hospital,Kyoto Prefectural University of Medicine	Kyoto-shi	Kyoto
Japan	Gunma University Hospital	Maebashi	Gunma
Japan	Nagoya City University Hospital	Nagoya	Aichi
Japan	National Hospital Organization Okayama Medical Center	Okayama
Japan	Osaka Metropolitan University Hospital	Osaka
Japan	Tohoku University Hospital	Sendai	Miyagi
Japan	Shizuoka Cancer Center	Sunto-gun	Shizuoka
Japan	Japanese Red Cross Medical Center	Tokyo
Japan	Iwate Medical University Hospital	Yahaba-cho, Shiwa-gun	Iwate
Japan	Yamagata University Hospital	Yamagata
Korea, Republic of	Pusan National University Hospital	Busan	Pusan-kwangyokshi
Korea, Republic of	Kyungpook National University	Daegu	Taegu-kwangyokshi
Korea, Republic of	Chonnam National University Hwasun Hospital	Hwasun Gun	Jeonranamdo
Korea, Republic of	Kyungpook National University Hospital	Jung-gu	Taegu-kwangyokshi
Korea, Republic of	Gachon University Gil Medical Center	Namdong-gu	Incheon-gwangyeoksi [incheon]
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Kyonggi-do
Korea, Republic of	Samsung Medical Center	Seoul	Seoul-teukbyeolsi [seoul]
Korea, Republic of	Seoul National University Hospital	Seoul	Seoul-teukbyeolsi [seoul]
Korea, Republic of	The Catholic Univ. of Korea Seoul St. Mary's Hospital	Seoul	Seoul-teukbyeolsi [seoul]
Korea, Republic of	The Catholic Univ. of Korea Seoul St. Mary's Hospital(Seoul St. Mary's Hospital)	Seoul	Seoul-teukbyeolsi [seoul]
Netherlands	HagaZiekenhuis	Den Haag	Zuid-holland
Netherlands	Maastricht Universitair Medisch Centrum	Maastricht
Netherlands	Isala	Zwolle
Norway	Haukeland Universitetssjukehus	Bergen	Hordaland
Norway	Oslo Universitetssykehus Ullevål	Oslo
Norway	Stavanger Universitetssykehus	Stavanger
Poland	Uniwersyteckie Centrum Kliniczne,	Gdansk
Poland	Pratia Onkologia Katowice	Katowice	Slaskie
Poland	Uniwersytecki Szpital Kliniczny w Poznaniu	Poznan
Poland	Centrum Medyczne Pratia Poznan	Skorzewo	Wielkopolskie
Poland	Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy	Warszawa
Poland	Uniwersyteckie Centrum Kliniczne WUM Centralny Szpital Kliniczny	Warszawa
Poland	Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku	Wroclaw
Spain	Institut Catala d' Oncologia. Hospital Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital Clínic de Barcelona	Barcelona	Catalunya [cataluña]
Spain	Hospital Universitari Vall d'Hebron	Barcelona	Barcelona [barcelona]
Spain	Institut Catala Oncologia - Hospital Universitari de Girona Dr Josep Trueta	Gerona
Spain	Institut Català d'Oncologia - L'Hospitalet	L'Hospitalet Del Llobregat	Barcelona [barcelona]
Spain	Clinica Universidad de Navarra	Madrid	Madrid, Comunidad DE
Spain	Hospital General Universitario Gregorio Marañon	Madrid
Spain	Hospital La Princesa	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario HM Sanchinarro	Madrid
Spain	Clinica Universidad de Navarra	Pamplona	Navarra
Spain	Hospital Universitario Quironsalud Madrid	Pozuelo de Alarcon	Madrid
Spain	Hospital Universitario de Salamanca	Salamanca	Castilla Y LEÓN
Spain	Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca	Salamanca
Spain	Complejo Hospitalario Universitario de Santiago	Santiago de Compostela	A Coruna
Spain	Hospital Universitari Mutua Terrassa	Terrassa	Barcelona [barcelona]
Spain	Hospital Universitari Mutua Terrassa	Terrassa	Barcelona
Spain	Hospital Universitari i Politecnic La Fe	València
Sweden	Södra Älvsborgs Sjukhus Borås	Borås	Västra Götalands LÄN [se-14]
Sweden	Falu Lasarett	Falun
Sweden	Helsingborgs Lasarett	Helsingborg	Skåne LÄN [se-12]
Sweden	Universitetssjukhuset i Linköping	Linköping	Östergötlands LÄN [se-05]
Sweden	Universitetssjukhuset Örebro	Örebro	Örebro LÄN [se-18]
Sweden	Karolinska Universitetssjukhuset Huddinge	Stockholm	Stockholms LÄN [se-01]
Taiwan	China Medical University Hospital	Taichung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Chang Gung Medical Foundation-Linkou Branch	Taoyuan
Turkey	Ankara Universitesi Tip Fakultesi Hastanesi	Ankara
Turkey	Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi	Ankara
Turkey	Gazi Universitesi	Ankara
Turkey	Akdeniz Universitesi Hastanesi	Antalya
Turkey	Aydin Adnan Menderes Universitesi Hastanesi	Aydin
Turkey	Medipol Mega Universite Hastanesi	Istanbul	I?stanbul
Turkey	Sisli Florence Nightingale Hastanesi	Istanbul	I?stanbul
Turkey	Dokuz Eylul Universitesi Hastanesi	Izmir	I?zmir
Turkey	Dokuz Eylul Universitesi Hastanesi	Izmir	I?zmir
Turkey	Ege Universitesi Hastanesi	Izmir	I?zmir
Turkey	Erciyes Universitesi Tip Fakultesi Hastaneleri	Kayseri
Turkey	Özel Anadolu Saglik Merkezi	Kocaeli
United Kingdom	The Beatson West of Scotland Cancer Centre	Glasgow
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University Hospital	Atlanta	Georgia
United States	Emory University Hospital Midtown	Atlanta	Georgia
United States	Investigational Drug Service, Emory University Clinic	Atlanta	Georgia
United States	Winship Cancer Institute, Emory University	Atlanta	Georgia
United States	Cleveland Clinic	Cleveland	Ohio
United States	OhioHealth Arthur G.H. Bing, MD, Cancer Center	Columbus	Ohio
United States	OhioHealth Research Institute	Columbus	Ohio
United States	OhioHealth Riverside Methodist Hospital	Columbus	Ohio
United States	OhioHealth Riverside Methodist Hospital	Columbus	Ohio
United States	Baylor University Medical Center	Dallas	Texas
United States	Banner Gateway Medical Center	Gilbert	Arizona
United States	Banner MD Anderson Cancer Center	Gilbert	Arizona
United States	University Of Mississippi Medical Center	Jackson	Mississippi
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Ronald Reagan UCLA Medical Center	Los Angeles	California
United States	UCLA Hematology/Oncology - Westwood (Building 200 Suite 120)	Los Angeles	California
United States	Alliance for Multispecialty Research, LLC	Merriam	Kansas
United States	Miami Cancer Institute at Baptist Health, Inc.	Miami	Florida
United States	Baylor Scott & White Medical Center - Temple	Temple	Texas
United States	Georgetown University Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Brazil,  Canada,  China,  Czechia,  Finland,  France,  Germany,  Greece,  Hungary,  India,  Israel,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Norway,  Poland,  Spain,  Sweden,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival	Progression Free Survival assessed by Blinded Independent Central review per IMWG response criteria	Assessed for up to approximately 5 years
Secondary	Overall Survival	Defined as the time from randomization until death due to any cause	Assessed for up to approximately 5 years
Secondary	Minimal Residual Disease negativity rate	Minimal Residual Disease negativity rate per IMWG criteria as assessed via Next Generation Sequencing	12 months after randomization
Secondary	Sustained MRD negativity rate	Sustained Minimal Residual Disease negativity rate per IMWG criteria as assessed via Next Generation Sequencing	24 months after randomization
Secondary	Progression Free Survival	Progression Free Survival by investigator per IMWG response criteria	Assessed for up to approximately 5 years
Secondary	Overall minimal residual disease negativity rate	Minimal residual disease negativity rate per IMWG criteria	Assessed for up to approximately 5 years
Secondary	Duration of minimal residual disease negativity	Minimal residual disease negativity per IMWG criteria	Assessed for up to approximately 5 years
Secondary	Sustained minimal residual disease negativity rate	Minimal residual disease negativity per IMWG criteria that has lasted a minimum of 12 months	Assessed for up to approximately 5 years
Secondary	Complete response rate	Complete response rate by blinded independent central review and by investigator per IMWG criteria	Assessed for up to approximately 5 years
Secondary	Duration of complete response	Duration of complete response by blinded independent central review and by investigator per IMWG criteria	Assessed for up to approximately 5 years
Secondary	Frequency of adverse events	Adverse event as characterized by type, frequency, severity per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5, seriousness and relationship to the study intervention	Up to 90 days after last dose
Secondary	Frequency of laboratory abnormalities		Assessed for up to approximately 5 years
Secondary	Pre-dose concentrations of elranatamab	Pharmacokinetics of elranatamab (trough concentrations of elranatamab)	Assessed for up to approximately 5 years
Secondary	Post-dose concentrations of elranatamab	Pharmacokinetics of elranatamab (Post-dose serum concentrations of elranatamab)"	Assessed for up to approximately 5 years
Secondary	Incidence and titers of Anti-Drug Antibody and Neutralizing Antibody against elranatamab	Immunogenicity of elranatamab	Assessed for up to approximately 5 years
Secondary	Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30	Higher scores on the functional scales represent higher levels of functioning. Higher scores on the global health status/quality of life scale represent higher health status/quality of life. Higher scores on symptom scales/items represent a greater presence of symptoms	Assessed for up to approximately 5 years
Secondary	Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Myeloma 20	Higher scores on the functioning subscales (body image, future perspective) represent higher levels of functioning, whereas higher scores on the symptom subscales (disease symptoms, side effects) represent a greater presence of symptoms	Assessed for up to approximately 5 years
Secondary	Progression Free Survival 2	Progression Free Survival to the date of second objective disease progression by investigator per IMWG response criteria	Assessed for up to approximately 5 years

External Links

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