Multiple Myeloma Clinical Trial
Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant
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
Full 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.
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 treatment-for-multiple-myeloma-induction-therapy/" >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)
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There are 184 Locations for this study
Gilbert Arizona, 85234, United States
Gilbert Arizona, 85234, United States
Los Angeles California, 90095, United States
Los Angeles California, 90095, United States
Washington District of Columbia, 20007, United States
Miami Florida, 33176, United States
Atlanta Georgia, 30308, United States
Atlanta Georgia, 30322, United States
Atlanta Georgia, 30322, United States
Atlanta Georgia, 30322, United States
Merriam Kansas, 66204, United States
Ann Arbor Michigan, 48109, United States
Jackson Mississippi, 39213, United States
Jackson Mississippi, 39216, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43214, United States
Columbus Ohio, 43214, United States
Columbus Ohio, 43214, United States
Columbus Ohio, 43214, United States
Dallas Texas, 75246, United States
Temple Texas, 76508, United States
Benowa Queensland, 4217, Australia
Clayfield Queensland, 4011, Australia
Woolloongabba Queensland, 4102, Australia
East Melbourne Victoria, 3002, Australia
East Melbourne Victoria, 3002, Australia
Fitzroy Victoria, 3065, Australia
Richmond , 3121, Australia
Vienna Wien, 1090, Austria
Vienna , 1140, Austria
Wien , 1090, Austria
Anderlecht Bruxelles-capitale, Région DE, 1070, Belgium
Charleroi Hainaut, 6000, Belgium
Yvoir Namur, 5530, Belgium
Antwerpen , 2020, Belgium
Antwerpen , 2030, Belgium
Antwerpen , 2030, Belgium
Antwerpen , 2060, Belgium
Antwerpen , 2060, Belgium
Brussel , 1090, Belgium
Salvador, Bahia, 41253, Brazil
Porto Alegre RIO Grande DO SUL, 90110, Brazil
Porto Alegre RIO Grande DO SUL, 90850, Brazil
Porto Alegre RIO Grande DO SUL, 90880, Brazil
Jaú SÃO Paulo, 17210, Brazil
Jaú SÃO Paulo, 17210, Brazil
Ribeirão Preto SÃO Paulo, 14051, Brazil
Sao Paulo SÃO Paulo, 01321, Brazil
SP SÃO Paulo, 04537, Brazil
Jaú , 17210, Brazil
Rio de Janeiro , 22775, Brazil
Rio de Janeiro , 22775, Brazil
São Paulo , 01232, Brazil
São Paulo , 04024, Brazil
São Paulo , 04024, Brazil
São Paulo , 04122, Brazil
São Paulo , 04537, Brazil
Calgary Alberta, T2N4N, Canada
Fredericton New Brunswick, E3B 5, Canada
Saint John New Brunswick, E2L 4, Canada
Hamilton Ontario, L8L 8, Canada
Toronto Ontario, M5G 2, Canada
Windsor Ontario, N8W 1, Canada
Montreal Quebec, H1T 2, Canada
Montreal Quebec, H4A 3, Canada
Montreal Quebec, H4J 1, Canada
Guangzhou Guangdong, 51006, China
Wuhan Hubei, 43003, China
Tianjin Tianjin, 30002, China
Wenzhou Zhejiang, 32500, China
Shanghai , 20043, China
Brno Brno-město, 625 0, Czechia
Hradec Kralove Hradec Králové, 500 0, Czechia
Ostrava-Poruba Moravskoslezský KRAJ, 708 5, Czechia
Ostrava Moravskoslezský KRAJ, 708 5, Czechia
Olomouc , 779 0, Czechia
Praha 2 , 12808, Czechia
Oulu Pohjois-pohjanmaa, 90220, Finland
Helsinki Uusimaa, 00029, Finland
Turku Varsinais-suomi, 20520, Finland
Toulouse Haute-garonne, 31100, France
Lille Nord, 59000, France
Paris Orne, 75013, France
Villejuif Val-de-marne, 94800, France
Poitiers Vienne, 86021, France
La Tronche , 38700, France
Lille , 59037, France
Paris Cedex 12 , 75571, France
Pierre Benite , 69495, France
Tours , 37032, France
Paris Île-de-france, 75571, France
Würzburg Bayern, 97080, Germany
Köln Nordrhein-westfalen, 50937, Germany
Mainz Rheinland-pfalz, 55131, Germany
Leipzig Sachsen, 04103, Germany
Kiel Schleswig-holstein, 24105, Germany
Berlin , 12200, Germany
Berlin , 12203, Germany
Chemnitz , 09116, Germany
Essen , 45147, Germany
München , 81675, Germany
Athens Attikí, 106 7, Greece
Athens Attikí, 115 2, Greece
Thessaloniki Kentrikí Makedonía, 546 3, Greece
Athens , 10676, Greece
Ioannina Ípeiros, 455 0, Greece
Kaposvár Somogy, 7400, Hungary
Budapest , 1088, Hungary
Budapest , 1097, Hungary
Debrecen , 4032, Hungary
Nyíregyháza , 4400, Hungary
Gurugram Haryana, 12200, India
Gurugram Haryana, 12200, India
Gurugram Haryana, 12200, India
Ranipet Tamil NADU, 63251, India
Dehradun Uttarakhand, 24814, India
Kolkata WEST Bengal, 70016, India
Delhi , 11008, India
Be'er Sheva Hadarom, 84101, Israel
Petah-Tikva Hamerkaz, 49100, Israel
Ramat Gan Hamerkaz, 52621, Israel
Haifa Hatsafon, 31096, Israel
Tel Aviv Tell Abīb, 64239, Israel
Jerusalem Yerushalayim, 90131, Israel
Jerusalem Yerushalayim, 91120, Israel
Jerusalem Yerushalayim, 91240, Israel
Jerusalem , 90131, Israel
Jerusalem , 91031, Israel
Meldola Emilia-romagna, 47014, Italy
Roma Lazio, 00168, Italy
Milano Lombardia, 20122, Italy
Catania Sicilia, 95123, Italy
Siena Toscana, 53100, Italy
Siena Toscana, 53100, Italy
Ancona , 60126, Italy
Bologna , 40138, Italy
Roma , 00161, Italy
Nagoya Aichi, 467-8, Japan
Maebashi Gunma, 371-8, Japan
Yahaba-cho, Shiwa-gun Iwate, 028-3, Japan
Kyoto-shi Kyoto, 602-8, Japan
Sendai Miyagi, 980-8, Japan
Hamamatsu-shi Shizuoka, 431-3, Japan
Sunto-gun Shizuoka, 411-8, Japan
Kumamoto , 860-0, Japan
Kyoto , 602-8, Japan
Okayama , 701-1, Japan
Osaka , 545-8, Japan
Tokyo , 150-8, Japan
Yamagata , 990-9, Japan
Namdong-gu Incheon-gwangyeoksi [incheon], 21565, Korea, Republic of
Hwasun Gun Jeonranamdo, 58128, Korea, Republic of
Seongnam Kyǒnggi-do, 13620, Korea, Republic of
Busan Pusan-kwangyǒkshi, 49241, Korea, Republic of
Seoul Seoul-teukbyeolsi [seoul], 03080, Korea, Republic of
Seoul Seoul-teukbyeolsi [seoul], 06351, Korea, Republic of
Seoul Seoul-teukbyeolsi [seoul], 06591, Korea, Republic of
Seoul Seoul-teukbyeolsi [seoul], 06591, Korea, Republic of
Daegu Taegu-kwangyǒkshi, 41944, Korea, Republic of
Jung-gu Taegu-kwangyǒkshi, 41944, Korea, Republic of
Den Haag Zuid-holland, 2545 , Netherlands
Maastricht , 6229 , Netherlands
Zwolle , 8025 , Netherlands
Bergen Hordaland, 5021, Norway
Oslo , 0450, Norway
Stavanger , 4011, Norway
Skorzewo Wielkopolskie, 60-18, Poland
Gdansk , 80-21, Poland
Poznan , 60-56, Poland
Warszawa , 02-09, Poland
Warszawa , 02-78, Poland
Wroclaw , 50-36, Poland
Katowice Śląskie, 40-51, Poland
Santiago de Compostela A Coruna, 15706, Spain
Barcelona Barcelona [barcelona], 08035, Spain
L'Hospitalet Del Llobregat Barcelona [barcelona], 08908, Spain
Terrassa Barcelona [barcelona], 08221, Spain
Badalona Barcelona, 08916, Spain
Terrassa Barcelona, 08221, Spain
Salamanca Castilla Y LEÓN, 37007, Spain
Barcelona Catalunya [cataluña], 08036, Spain
Madrid Madrid, Comunidad DE, 28027, Spain
Pozuelo de Alarcon Madrid, 28223, Spain
Pamplona Navarra, 31008, Spain
Gerona , 17007, Spain
Madrid , 28006, Spain
Madrid , 28007, Spain
Madrid , 28041, Spain
Madrid , 28050, Spain
Salamanca , 37007, Spain
València , 46026, Spain
Helsingborg Skåne LÄN [se-12], 251 8, Sweden
Stockholm Stockholms LÄN [se-01], 141 8, Sweden
Borås Västra Götalands LÄN [se-14], 501 8, Sweden
Falun , 791 3, Sweden
Örebro Örebro LÄN [se-18], 701 8, Sweden
Linköping Östergötlands LÄN [se-05], 581 8, Sweden
Taichung , 40447, Taiwan
Taichung , 407, Taiwan
Taipei , 10002, Taiwan
Taipei , 11217, Taiwan
Taoyuan , 333, Taiwan
İstanbul İ̇stanbul, 34214, Turkey
İstanbul İ̇stanbul, 34381, Turkey
Izmir İ̇zmir, 35100, Turkey
İzmir İ̇zmir, 35340, Turkey
İzmir İ̇zmir, 35340, Turkey
Ankara , 06100, Turkey
Ankara , 06200, Turkey
Ankara , 06560, Turkey
Antalya , 07070, Turkey
Aydin , 09100, Turkey
Kayseri , 38030, Turkey
Kocaeli , 41400, Turkey
Glasgow , G12 0, United Kingdom
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