AN OPEN-LABEL, 3-ARM, MULTICENTER, RANDOMIZED PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ELRANATAMAB (PF-06863135) MONOTHERAPY AND ELRANATAMAB + DARATUMUMAB VERSUS DARATUMUMAB + POMALIDOMIDE + DEXAMETHASONE IN PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST 1 PRIOR LINE OF THERAPY INCLUDING LENALIDOMIDE AND A PROTEASOME INHIBITOR
AN OPEN-LABEL, 3-ARM, MULTICENTER, RANDOMIZED PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ELRANATAMAB (PF-06863135) MONOTHERAPY AND ELRANATAMAB + DARATUMUMAB VERSUS DARATUMUMAB + POMALIDOMIDE + DEXAMETHASONE IN PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST 1 PRIOR LINE OF THERAPY INCLUDING LENALIDOMIDE AND A PROTEASOME INHIBITOR
The purpose of this clinical trial is to (1) learn whether the BCMA-CD3 bispecific antibody elranatamab can provide more benefit to people with multiple myeloma compared to a combination therapy including daratumumab, pomalidomide, and dexamethasone, and (2) learn about the safety and activity of elranatamab in combination with the anti-CD38 monoclonal antibody daratumumab. People with multiple myeloma who have received previous treatment including lenalidomide will be enrolled in the study.
Part 1 of the study will assess the safety and activity of different doses of elranatamab in combination with daratumumab.
People participating in Part 2 of the study will be randomly assigned to receive either elranatamab alone, elranatamab plus daratumumab, or daratumumab, pomalidomide, and dexamethasone. Part 2 will evaluate the safety and activity of (1) elranatamab alone compared to daratumumab, pomalidomide, and dexamethasone, and (2) elranatamab plus daratumumab.
Part 3 will assess the effect of increased measures to protect against infection in people treated with either elranatamab alone or together with daratumumab.
All people participating in the study will receive study treatment until their disease progresses, they experience unacceptable side effects, or they choose to no longer participate in the study.
Inclusion Criteria:
Prior diagnosis of multiple myeloma as defined by IMWG criteria (Rajkumar et al, 2014).
Measurable disease based on IMWG criteria as defined by at least 1 of the following:
Prior anti-multiple myeloma therapy including treatment with lenalidomide.
ECOG performance status ≤2.
Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1.
Not pregnant and willing to use contraception.
Exclusion Criteria:
ClinicalTrials.gov_Inquiries@pfizer.com1-800-718-1021
Loveland, Colorado 80538, United States
Coral Gables, Florida 33146, United States
Coral Springs, Florida 33065, United States
Deerfield Beach, Florida 33442, United States
Plantation, Florida 33324, United States
New York, New York 10021, United States
New York, New York 10065, United States
Ciudad Autonoma de Buenos Aires, Buenos Aires 1426, Argentina
Ciudad Autonoma de Buenos Aires, Buenos Aires C1114AAN, Argentina
Ciudad Autónoma de Buenos Aires, Buenos Aires C1114AAP, Argentina
Ciudad Autónoma de Buenos Aires, Buenos Aires C1114AAP, Argentina
Presidente Derqui, Buenos Aires B1629AHJ, Argentina
Salvador, Estado de Bahia 41253-190, Brazil
Porto Alegre, Rio Grande do Sul 90110-270, Brazil
Porto Alegre, Rio Grande do Sul 90850-170, Brazil
São Paulo, São Paulo 01321-001, Brazil
SP, São Paulo 04537-080, Brazil
Rio de Janeiro, 22793-080, Brazil
São Paulo, 01232-010, Brazil
Hamilton, Ontario L8V5C2, Canada
Shijiazhuang, Hebei 050000, China
Wuhan, Hubei 430030, China
Nanjing, Jiangsu 210008, China
Xuzhou, Jiangsu 221006, China
Nanchang, Jiangxi 330006, China
Wenzhou, Zhejiang 325000, China
Beijing, 100730, China
Plzen - Lochotin, Plzeň Region 304 60, Czechia
Ostrava-Poruba, 708 52, Czechia
Helsinki, 00029, Finland
Limoges, Limousin 87042, France
Nantes, 44093, France
Pierre-Bénite, 69495, France
Poitiers, 86021, France
Toulouse, 31059, France
München, 81675, Germany
Thessaloniki, Kentrikí Makedonía 546 39, Greece
Meldola, Emilia-Romagna 47014, Italy
Milan, Milan 20153, Italy
Bologna, 40138, Italy
Yoshida-gun, Fukui 910-1193, Japan
Shibukawa, Gunma 377-0280, Japan
Yahaba-cho, Iwate 028-3695, Japan
Sunto-gun, Shizuoka 411-8777, Japan
Shibuya-ku, Tokyo 150-8935, Japan
Colonia Valle de Las Palmas, México 52787, Mexico
Monterrey, Nuevo León 66460, Mexico
Rotterdam, South Holland 3015 GD, Netherlands
Wellington, 6021, New Zealand
Bydgoszcz, 85-168, Poland
Warsaw, 02-097, Poland
Wroclaw, 50-367, Poland
Seongnam-si, Gyeonggi-do 13620, South Korea
Hwasun-gun, Jeonranamdo 58128, South Korea
Seoul, Seoul-teukbyeolsi [seoul] 03080, South Korea
Seoul, Seoul-teukbyeolsi [seoul] 06591, South Korea
Daegu, Taegu-kwangyǒkshi 41944, South Korea
Santiago de Compostela, A Coruna 15706, Spain
L'Hospitalet Del Llobregat, Barcelona [barcelona] 08908, Spain
Istanbul, İ̇stanbul 34093, Turkey (Türkiye)
Istanbul, İ̇stanbul 34303, Turkey (Türkiye)
Adana, 01240, Turkey (Türkiye)
Ankara, 06100, Turkey (Türkiye)
Ankara, 06200, Turkey (Türkiye)
Gaziantep, 27310, Turkey (Türkiye)
Kayseri, 38030, Turkey (Türkiye)
Oxford, Oxfordshire OX3 7LE, United Kingdom