Multiple Myeloma Clinical Trial
A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma
Summary
The purpose of this study is to compare the efficacy of teclistamab-daratumumab (Tec-Dara) with daratumumab subcutaneously (SC) in combination with pomalidomide and dexamethasone (DPd) or daratumumab SC in combination with bortezomib and dexamethasone (DVd) in Part 1 and to evaluate the pharmacokinetics (PK), safety, and efficacy of the Tec-Dara regimen when teclistamab is administered using a alternative dosing schedule in Part 2.
Full Description
Teclistamab is a novel B-cell maturation antigen (BCMA) bispecific antibody that is being evaluated to treat participants with multiple myeloma, an incurable malignant plasma cell disorder. The primary hypothesis of this study is that Tec-Dara will significantly improve progression free survival (PFS) compared with investigator's choice of DPd/DVd in participants with relapsed refractory multiple myeloma. Approximately 560 participants will be randomly assigned in a 1:1 ratio to receive either Tec-Dara (Arm A) or investigator's choice of DPd/DVd (Arm B). The study will be conducted in 3 phases: Screening Phase, Treatment Phase, and Follow-up Phase. Participants will be treated until disease progression, unacceptable toxicity, or other reasons to discontinue the study. Disease evaluation will occur every cycle. Safety will be assessed throughout the study. Efficacy will be assessed using International Myeloma Working Group (IMWG) criteria. The overall duration of the study will be approximately 5 years.
Eligibility Criteria
Inclusion Criteria:
Documented multiple myeloma as defined by the criteria: a. multiple myeloma diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria, b. measurable disease at screening as defined by any of the following: 1) serum M-protein level greater than or equal to (>=) 0.5 gram per deciliter (g/dL); or 2) urine M-protein level >=200 milligrams (mg)/24 hours; or 3) serum immunoglobulin free light chain >=10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio
Received 1 to 3 prior line(s) of antimyeloma therapy including a proteasome inhibitor (PI) and lenalidomide; a. participants who have received only 1 line of prior line of antimyeloma therapy must be lenalidomide refractory. Stable disease or progression on or within 60 days of the last dose of lenalidomide given as maintenance will meet this criterion
Documented evidence of progressive disease based on investigator's determination of response by IMWG criteria on or after their last regimen
Have an eastern cooperative oncology group (ECOG) performance status score of 0, 1, or 2 at screening and prior to the start of administration of study treatment
Have clinical laboratory values within the specified range
Exclusion Criteria:
Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients. Additional exclusion criteria pertaining to specific study drugs include:
A participant is not eligible to receive daratumumab subcutaneous (SC) in combination with pomalidomide and dexamethasone (DPd) as control therapy if any of the following are present: 1) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to pomalidomide, 2) Disease that is considered refractory to pomalidomide per IMWG,
A participant is not eligible to receive daratumumab SC in combination with bortezomib and dexamethasone (DVd) as control therapy if any of the following are present: 1) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to bortezomib, 2) Grade 1 peripheral neuropathy with pain or Grade >= 2 peripheral neuropathy as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0, 3) Disease that is considered refractory to bortezomib per IMWG, 4) Received a strong cytochromes P450 (CYP3A4) inducer within 5 half-lives prior to randomization
Received any prior B cell maturation antigen (BCMA)-directed therapy
Has disease that is considered refractory to an anti-cluster of differentiation 38 (CD38) monoclonal antibody per IMWG
Received a cumulative dose of corticosteroids equivalent to >=140 mg of prednisone within 14 days before randomization
Received a live, attenuated vaccine within 4 weeks before randomization
Plasma cell leukemia at the time of screening, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary amyloid light chain amyloidosis
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There are 174 Locations for this study
Birmingham Alabama, 35294, United States
Duarte California, 91010, United States
Stanford California, 94305, United States
New Haven Connecticut, 06510, United States
Atlanta Georgia, 30322, United States
Boston Massachusetts, 02111, United States
Detroit Michigan, 48202, United States
Southfield Michigan, 48075, United States
Cleveland Ohio, 44195, United States
Pittsburgh Pennsylvania, 15224, United States
Pittsburgh Pennsylvania, 15232, United States
Charleston South Carolina, 29425, United States
Memphis Tennessee, 38120, United States
Nashville Tennessee, 37232, United States
Dallas Texas, 75235, United States
Salt Lake City Utah, 84112, United States
Seattle Washington, 98109, United States
Madison Wisconsin, 53792, United States
Buenos Aires , C1118, Argentina
Buenos Aires , C1199, Argentina
Cordoba , X5016, Argentina
Antwerpen , 2060, Belgium
Brugge , 8000, Belgium
Gent , 9000, Belgium
Haine-saint-paul, LA Louviere , 7100, Belgium
Kortrijk , 8500, Belgium
Leuven , 3000, Belgium
Roeselare , 8800, Belgium
Brasilia , 70390, Brazil
Curitiba , 81520, Brazil
Florianopolis , 88034, Brazil
Natal , 59062, Brazil
Porto Alegre , 90050, Brazil
Rio de Janeiro , 22775, Brazil
Salvador , 41253, Brazil
Sao Paulo , 01455, Brazil
São Paulo , 01321, Brazil
São Paulo , 01323, Brazil
São Paulo , 45010, Brazil
Calgary Alberta, T2N 4, Canada
Edmonton Alberta, T6G 1, Canada
Vancouver British Columbia, V5Z 4, Canada
Halifax Nova Scotia, B3H 2, Canada
Toronto Ontario, M5G 1, Canada
Beijing , 10002, China
Beijing , 10003, China
Beijing , 10004, China
Beijing , 10019, China
Changchun , 13002, China
Changshashi , 41001, China
Chengdu , 61004, China
Fuzhou , 35000, China
Guangzhou , 51006, China
Hangzhou , 31000, China
Hangzhou , 31000, China
Nanjing , 21000, China
Nanning , 53002, China
Shanghai , 20003, China
Shenyang , 11002, China
Shenzhen , 51803, China
Tianjin , 30001, China
Tianjin , 30006, China
Xi'an , 71000, China
Xuzhou , 22100, China
Zhengzhou , 45000, China
Aalborg , DK-90, Denmark
Aarhus N , DK-82, Denmark
Copenhagen , 2100, Denmark
Odense , 5000, Denmark
Vejle , DK-71, Denmark
Creteil , 94000, France
LILLE Cedex , 59037, France
Limoges , 87042, France
Nantes , 44093, France
Pierre Benite cedex , 69495, France
Poitiers , 86021, France
Strasbourg , 67200, France
Toulouse cedex 9 , 31059, France
Tours , 37044, France
Dresden , 01307, Germany
Düsseldorf , 40225, Germany
Essen , 45239, Germany
Freiburg , 79106, Germany
Hamburg , 20246, Germany
Hamm , 59073, Germany
Heidelberg , 69120, Germany
Kiel , 24105, Germany
Leipzig , 04103, Germany
Tübingen , 72076, Germany
Athens Attica , 115 2, Greece
Thessaloniki , 546 3, Greece
Thessaloniki , 57010, Greece
Bari , 70124, Italy
Bergamo , 24127, Italy
Bologna , 40138, Italy
Firenze , 50134, Italy
Meldola , 47014, Italy
Pavia , 27100, Italy
Roma , 00161, Italy
Turin , 10126, Italy
Fukuoka , 814-0, Japan
Gifu , 503-8, Japan
Higashiibaraki-gun , 311-3, Japan
Hyôgo , 663-8, Japan
Isehara , 259-1, Japan
Kamakura-shi , 247-8, Japan
Kashiwa , 277-8, Japan
Koshigaya , 343-8, Japan
Kumamoto , 860-8, Japan
Kurume , 830-0, Japan
Matsumoto , 399-8, Japan
Nagoya , 467-8, Japan
Okayama , 701-1, Japan
Otake , 739-0, Japan
Sapporo-shi , 060-8, Japan
Sendai-City , 983-8, Japan
Sendai , 980-8, Japan
Shibuya-ku , 150-8, Japan
Shiwa-gun , 028-3, Japan
Daegu , 41944, Korea, Republic of
Incheon , 21565, Korea, Republic of
Jeollanam-do , 58128, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 06591, Korea, Republic of
Amsterdam , 1081 , Netherlands
Groningen , 9713 , Netherlands
Nieuwegein , 3435 , Netherlands
Nijmegen , 6525G, Netherlands
Zwolle , 8025 , Netherlands
Gdansk , 80-21, Poland
Katowice , 40-51, Poland
Kielce , 25-73, Poland
Lublin , 20-09, Poland
Warszawa , 02-78, Poland
Wałbrzych , 58-30, Poland
Wroclaw , 50-36, Poland
Moscow , 12528, Russian Federation
Moscow , 12528, Russian Federation
St-Petersburg , 19102, Russian Federation
Barcelona , 08908, Spain
Barcelona , 8035, Spain
Gijón , 33394, Spain
Las Palmas de Gran Canaria , 35010, Spain
Madrid , 28007, Spain
Madrid , 28034, Spain
Madrid , 28041, Spain
Palma , 7120, Spain
Pamplona , 31008, Spain
Pozuelo de Alarcon , 28223, Spain
Salamanca , 37007, Spain
Santander , 39008, Spain
Santiago de Compostela , 15706, Spain
Sevilla , 41013, Spain
Valencia , 46026, Spain
Falun , 791 8, Sweden
Göteborg , 413 4, Sweden
Helsingborg , 25187, Sweden
Luleå , 971 8, Sweden
Lund , 221 8, Sweden
Umea , 901 8, Sweden
Uppsala , 75185, Sweden
Taichung , 40447, Taiwan
Tainan , 704, Taiwan
Taoyuan , 333, Taiwan
Ankara , 06590, Turkey
Atakum , 55280, Turkey
Istanbul , 34214, Turkey
Izmir , 35340, Turkey
Blackpool , FY3 8, United Kingdom
Dundee , DD1 9, United Kingdom
London , SE5 9, United Kingdom
Oxford , OX3 7, United Kingdom
Plymouth , PL6 8, United Kingdom
Sutton , SM2 5, United Kingdom
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