AN OPEN-LABEL, 2-ARM, MULTICENTER, RANDOMIZED PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ELRANATAMAB (PF-06863135) + DARATUMUMAB + LENALIDOMIDE VERSUS DARATUMUMAB + BORTEZOMIB + LENALIDOMIDE + DEXAMETHASONE IN TRANSPLANT-INELIGIBLE PARTICIPANTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA
AN OPEN-LABEL, 2-ARM, MULTICENTER, RANDOMIZED PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ELRANATAMAB (PF-06863135) + DARATUMUMAB + LENALIDOMIDE VERSUS DARATUMUMAB + BORTEZOMIB + LENALIDOMIDE + DEXAMETHASONE IN TRANSPLANT-INELIGIBLE PARTICIPANTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA
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. The main purpose of the study is to evaluate if the combination of Elranatamab, Daratumumab and Lenalidomide offers superior clinical benefit compared with the combination of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in people with newly diagnosed multiple myeloma.
There are 2 parts to this study. Part 1 will characterize the safety and tolerability of elranatamab in combination with daratumumab and lenalidomide or in combination with lenalidomide and will identify the optimal dose(s) of the combination regimen. Part 2 of the study will evaluate the rate of minimal residual disease (MRD) negative CR and the progression free survival (PFS) of the combination of elranatamab, daratumumab, and lenalidomide compared with the combination of daratumumab, bortezomib, lenalidomide, and dexamethasone in participants with newly diagnosed multiple myeloma.
Inclusion Criteria:
Diagnosis of multiple myeloma (MM) as defined by IMWG criteria (Rajkumar et al., 2014)
Measurable disease based on IMWG criteria as defined by at least 1 of the following:
Part 1: Participants with relapsed/refractory multiple myeloma (RRMM) who have received 1-2 prior lines of therapy including at least one immunomodulatory drug and one proteasome inhibitor: or participants with newly-diagnosed multiple myeloma (NDMM) that are transplant-ineligible as defined by age ≥65 years or transplant-ineligible as defined by age <65 years with comorbidities impacting the possibility of transplant.
Part 2: participants with newly-diagnosed multiple myeloma that are transplant-ineligible defined as:
ECOG performance status ≤2.
Not pregnant and willing to use contraception
For participants with RRMM: Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1.
Exclusion Criteria:
ClinicalTrials.gov_Inquiries@pfizer.com1-800-718-1021
Jupiter, Florida 33458, United States
New York, New York 10021, United States
Yvoir, Namur 5530, Belgium
Ribeirão Preto, São Paulo 14051-140, Brazil
Wuhan, Hubei 430030, China
Shanghai, Shanghai Municipality 200434, China
Hangzhou, Zhejiang 310003, China
Wenzhou, Zhejiang 325000, China
Helsinki, 00029, Finland
Nice, Alpes-maritimes 06200, France
Toulouse, Haute-garonne 31100, France
Nantes, 44093 Cedex 1, France
Mainz, Rhineland-Palatinate 55131, Germany
Thessaloniki, Kentrikí Makedonía 540 07, Greece
Ramat Gan, Central District 5265601, Israel
Meldola (Fc), Emilia-Romagna 47014, Italy
Turin, Piedmont 10126, Italy
Yoshida-gun, Fukui 910-1193, Japan
Yahaba-cho, Iwate 028-3695, Japan
Nagaizumi-cho, Shizuoka 411-8777, Japan
Shibuya-ku, Tokyo 150-8935, Japan
Dordrecht, South Holland 3318 AT, Netherlands
Wroclaw, Lower Silesian Voivodeship 50-367, Poland
Hwasun-gun, Jeonranamdo 58128, South Korea
Seoul, Seoul-teukbyeolsi [seoul] 06591, South Korea
Seoul, Seoul-teukbyeolsi [seoul] 06591, South Korea
Santiago de Compostela, A Coruña [LA Coruña] 15706, Spain
L'Hospitalet Del Llobregat, Barcelona [barcelona] 08908, Spain