Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant
Launched by PFIZER · Mar 30, 2022
Trial Information
Current as of August 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment called elranatamab to see if it is more effective than a standard treatment called lenalidomide for patients with newly diagnosed multiple myeloma who have recently had a stem cell transplant. The goal is to find out if elranatamab, given as an injection under the skin, can help patients more than taking lenalidomide as a pill at home. The trial will last about five years and involves two parts where participants will be randomly assigned to receive either treatment.
To be eligible for this study, participants must have been diagnosed with multiple myeloma and have measurable disease after their stem cell transplant. They should also have had prior treatment for their condition and be in good overall health. Importantly, those who join the trial will need to provide a bone marrow sample to help track their disease. Throughout the study, participants will be monitored closely for their health and response to treatment. This trial is currently recruiting and welcomes patients aged 65 to 74, regardless of gender.
Gender
ALL
Eligibility criteria
- 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)
About Pfizer
Pfizer Inc. is a global leader in biopharmaceutical innovation, dedicated to discovering, developing, and delivering advanced therapies that enhance patient outcomes across a wide range of medical conditions. With a rich history of scientific research and a commitment to quality, Pfizer focuses on areas such as oncology, immunology, cardiology, and rare diseases. The company leverages cutting-edge technology and collaborates with healthcare professionals, regulatory bodies, and academic institutions to conduct rigorous clinical trials that ensure the safety and efficacy of its products. Pfizer's mission is to bring breakthroughs that change patients' lives, exemplifying its commitment to health and wellness worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Ann Arbor, Michigan, United States
Saint John, New Brunswick, Canada
Calgary, Alberta, Canada
Westmead, New South Wales, Australia
Athens, , Greece
Madrid, , Spain
Madrid, , Spain
Dallas, Texas, United States
Wollongong, New South Wales, Australia
Washington, District Of Columbia, United States
Valhalla, New York, United States
Cleveland, Ohio, United States
Wakefield, , United Kingdom
Lebanon, New Hampshire, United States
Atlanta, Georgia, United States
Salamanca, , Spain
Camperdown, New South Wales, Australia
Woolloongabba, Queensland, Australia
Atlanta, Georgia, United States
Antwerpen, , Belgium
Madrid, , Spain
Belfast, , United Kingdom
Barcelona, , Spain
Taipei, , Taiwan
Barcelona, , Spain
Budapest, , Hungary
Essen, , Germany
Cambridge, Cambridgeshire, United Kingdom
Sendai, Miyagi, Japan
Glasgow, , United Kingdom
Taipei, , Taiwan
Hamamatsu, Shizuoka, Japan
Taichung, , Taiwan
Los Angeles, California, United States
Yamagata, , Japan
Taichung, , Taiwan
Wolverhampton, , United Kingdom
Zürich, , Switzerland
Stockholm, , Sweden
Atlanta, Georgia, United States
Leipzig, Sachsen, Germany
Seoul, , Korea, Republic Of
Jackson, Mississippi, United States
Madrid, , Spain
Sunto Gun, Shizuoka, Japan
Tokyo, , Japan
Maywood, Illinois, United States
Barcelona, , Spain
Brussel, , Belgium
Antwerpen, , Belgium
Guangzhou, Guangdong, China
Calgary, Alberta, Canada
Bunkyo Ku, Tokyo, Japan
Delhi, , India
Reading, , United Kingdom
Winterthur, , Switzerland
Nagoya, Aichi, Japan
Okayama, , Japan
Madrid, , Spain
Taoyuan, , Taiwan
München, , Germany
Hradec Kralove, , Czechia
Jerusalem, , Israel
Toronto, Ontario, Canada
Kyoto, , Japan
Chemnitz, , Germany
Budapest, , Hungary
Taipei, , Taiwan
örebro, , Sweden
Baden, , Switzerland
Pamplona, Navarra, Spain
Ostrava, , Czechia
Seongnam, , Korea, Republic Of
Montreal, Quebec, Canada
Wien, , Austria
Würzburg, Bayern, Germany
Charleroi, Hainaut, Belgium
Cáceres, , Spain
Maastricht, , Netherlands
Gilbert, Arizona, United States
Paris Cedex 12, , France
Wroclaw, , Poland
Columbus, Ohio, United States
Anderlecht, , Belgium
Glasgow, , United Kingdom
Fitzroy, Victoria, Australia
Hamilton, Ontario, Canada
Birmingham, , United Kingdom
Debrecen, , Hungary
Maebashi, Gunma, Japan
Nagaizumi, Shizuoka, Japan
Atlanta, Georgia, United States
Busan, , Korea, Republic Of
Daegu, , Korea, Republic Of
Meldola, Emilia Romagna, Italy
Wenzhou, Zhejiang, China
Hamamatsu Shi, Shizuoka, Japan
Kaposvár, Somogy, Hungary
Kobe City, Hyogo, Japan
Kumamoto, , Japan
Gent, Oost Vlaanderen, Belgium
Olomouc, , Czechia
Helsingborg, , Sweden
Linköping, , Sweden
Lausanne, Vaud, Switzerland
Madrid, , Spain
Zwolle, , Netherlands
Salamanca, Castilla Y León, Spain
Shibuya Ku, Tokyo, Japan
Stavanger, , Norway
Gerona, , Spain
Columbus, Ohio, United States
Praha 2, , Czechia
Katowice, , Poland
Ioannina, , Greece
Warszawa, , Poland
Kagoshima, , Japan
Pozuelo De Alarcon, Madrid, Spain
Osaka, , Japan
Ankara, , Turkey
Terrassa, Barcelona, Spain
Birmingham, England, United Kingdom
La Tronche, , France
Turku, Varsinais Suomi, Finland
Santiago De Compostela, A Coruna, Spain
Nyíregyháza, , Hungary
Vienna, , Austria
Seoul, Gangnam Gu, Korea, Republic Of
Roma, , Italy
East Melbourne, Victoria, Australia
Gilbert, Arizona, United States
Roma, Lazio, Italy
Fredericton, New Brunswick, Canada
Gurugram, Haryana, India
Benowa, Queensland, Australia
Miami, Florida, United States
Seongnam, Kyǒnggi Do, Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Kolkata, West Bengal, India
Milano, Lombardia, Italy
Wroclaw, , Poland
València, , Spain
Temple, Texas, United States
Berne, , Switzerland
Haifa, North, Israel
Madrid, , Spain
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Gurugram, Haryana, India
Jaú, São Paulo, Brazil
Jaú, São Paulo, Brazil
Salamanca, , Spain
Jerusalem, , Israel
Mainz, Rheinland Pfalz, Germany
Den Haag, Zuid Holland, Netherlands
Ramat Gan, Hamerkaz, Israel
Athens, , Greece
Bologna, , Italy
Busan, Pusan Kwangyǒkshi, Korea, Republic Of
Nowra, New South Wales, Australia
Siena, Toscana, Italy
Berlin, , Germany
Vienna, Wien, Austria
Katowice, śląskie, Poland
Brno, Brno Město, Czechia
Hradec Kralove, Hradec Králové, Czechia
Oslo, , Norway
Yahaba Cho, Shiwa Gun, Iwate, Japan
Terrassa, , Spain
Budapest, , Hungary
Charleroi, Hainaut, Belgium
Porto Alegre, Rio Grande Do Sul, Brazil
Haifa, Hatsafon, Israel
Jerusalem, Yerushalayim, Israel
Siena, Toscana, Italy
Kiel, Schleswig Holstein, Germany
Namdong Gu, , Korea, Republic Of
Barcelona, Barcelona [Barcelona], Spain
Tianjin, Tianjin, China
Oulu, Pohjois Pohjanmaa, Finland
Lille, Nord, France
Poitiers, Vienne, France
Athens, Attikí, Greece
Athens, Attikí, Greece
Thessaloniki, Kentrikí Makedonía, Greece
Catania, Sicilia, Italy
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
L'hospitalet Del Llobregat, Barcelona [Barcelona], Spain
Helsingborg, , Sweden
örebro, , Sweden
Linköping, , Sweden
İstanbul, İ̇stanbul, Turkey
İzmir, İ̇zmir, Turkey
Ankara, , Turkey
Antalya, , Turkey
Aydin, , Turkey
Kocaeli, , Turkey
Ancona, , Italy
Skorzewo, Wielkopolskie, Poland
Tel Aviv, Tell Abīb, Israel
Barcelona, Catalunya [Cataluña], Spain
Be'er Sheva, Hadarom, Israel
Los Angeles, California, United States
Richmond, , Australia
Yvoir, Namur, Belgium
Helsinki, Uusimaa, Finland
Toulouse, Haute Garonne, France
Pierre Benite, , France
Paris, île De France, France
Ioannina, ípeiros, Greece
Gurugram, Haryana, India
Gurugram, Haryana, India
Siena, Toscana, Italy
Kyoto Shi, Kyoto, Japan
Hwasun Gun, Jeonranamdo, Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Daegu, Taegu Kwangyǒkshi, Korea, Republic Of
Jung Gu, Taegu Kwangyǒkshi, Korea, Republic Of
Gdansk, , Poland
Terrassa, Barcelona [Barcelona], Spain
Badalona, Barcelona, Spain
İstanbul, İ̇stanbul, Turkey
Izmir, İ̇zmir, Turkey
Kayseri, , Turkey
Madrid, Madrid, Comunidad De, Spain
Ankara, , Turkey
Anderlecht, Bruxelles Capitale, Région De, Belgium
Porto Alegre, Rio Grande Do Sul, Brazil
Warszawa, , Poland
Villejuif, Val De Marne, France
Calgary, Alberta, Canada
Bergen, Hordaland, Norway
Stockholm, , Sweden
Borås, , Sweden
Ostrava, Moravskoslezský Kraj, Czechia
Vienna, Wien, Austria
Köln, Nordrhein Westfalen, Germany
East Melbourne, Victoria, Australia
Falun, , Sweden
Sao Paulo, São Paulo, Brazil
São Paulo, , Brazil
Montreal, Quebec, Canada
Salvador,, Bahia, Brazil
São Paulo, , Brazil
São Paulo, , Brazil
Nyíregyháza, , Hungary
Ostrava Poruba, Moravskoslezský Kraj, Czechia
Los Angeles, California, United States
Poznan, , Poland
São Paulo, , Brazil
São Paulo, , Brazil
Berlin, , Germany
Merriam, Kansas, United States
Tel Aviv, Tell Abīb, Israel
Madrid, Madrid, Comunidad De, Spain
Lille, , France
Haifa, Hatsafon, Israel
Tours, , France
Bologna, , Italy
Jerusalem, Yerushalayim, Israel
Shanghai, , China
Yvoir, Namur, Belgium
Namdong Gu, , Korea, Republic Of
Meldola, Emilia Romagna, Italy
Jaú, São Paulo, Brazil
Jaú, , Brazil
Rio De Janeiro, , Brazil
Rio De Janeiro, , Brazil
Ranipet, Tamil Nadu, India
Dehradun, Uttarakhand, India
Ribeirão Preto, São Paulo, Brazil
Montreal, Quebec, Canada
Columbus, Ohio, United States
Clayfield, Queensland, Australia
Porto Alegre, Rio Grande Do Sul, Brazil
Paris, Orne, France
Seoul, , Korea, Republic Of
Wuhan, Hubei, China
Toronto, Ontario, Canada
Izmir, , Turkey
Antwerpen, , Belgium
Antwerpen, , Belgium
Windsor, Ontario, Canada
Petah Tikva, Hamerkaz, Israel
Sp, São Paulo, Brazil
Salvador, Bahia, Brazil
Thessaloniki, , Greece
Ribeirão Preto, São Paulo, Brazil
Montreal, Quebec, Canada
İzmir, , Turkey
Sao Paulo, , Brazil
Leawood, Kansas, United States
Mission, Kansas, United States
Ribeirão Preto, São Paulo, Brazil
Montreal, Quebec, Canada
Jung Gu, , Korea, Republic Of
Tokyo, , Japan
Zürich, Zürich (De), Switzerland
Hawthorne, New York, United States
Calgary, Alberta, Canada
Merriam, Kansas, United States
Dewsbury, Wakefield, United Kingdom
Pontefract, Wakefield, United Kingdom
Ankara, , Turkey
Yahaba Cho, Iwate, Japan
Gilbert, Arizona, United States
Merriam, Kansas, United States
Kansas City, Missouri, United States
Kansas City, Missouri, United States
Brno, , Czechia
İstanbul, , Turkey
Sp, , Brazil
L'hospitalet Del Llobregat, , Spain
İstanbul, , Turkey
Jaú, , Brazil
Ribeirão Preto, , Brazil
Tel Aviv, , Israel
Seoul, , Korea, Republic Of
Borås, , Sweden
Merriam, Kansas, United States
Patients applied
Trial Officials
Pfizer CT.gov Call Center
Study Director
Pfizer
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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