Spots Global Cancer Trial Database for A Study of Modakafusp Alfa Together With Daratumumab Adults With Relapsed or Refractory Multiple Myeloma
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Trial Identification
Brief Title: A Study of Modakafusp Alfa Together With Daratumumab Adults With Relapsed or Refractory Multiple Myeloma
Official Title: A Phase 1/2a Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Modakafusp Alfa in Combination With Daratumumab Subcutaneous in Patients With Relapsed or Refractory Multiple Myeloma
Study ID: NCT05590377
Conditions
Study Description
Brief Summary: The main aim of this study is to determine safety and tolerability of modakafusp alfa given together with daratumumab to find out the best treatment dose. Another aim of this study is to learn more about the characteristics of modakafusp alfa.
Detailed Description: The drug being tested in this study is called modakafusp alfa (TAK-573). Modakafusp alfa is being tested to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy in combination with daratumumab in participants with relapsed or refractory multiple myeloma (RRMM). The study will consist of 2 phases: Phase 1 Dose Escalation and a Phase 2a Dose Finding. The study will enroll approximately 58 patients. Approximately 18 participants will be enrolled in the Phase 1 Dose Escalation/De-escalation and two dose levels of modakafusp alfa in combination with daratumumab SC will be selected to be further explored in the randomized Phase 2a Dose Finding part of the study wherein, approximately 40 participants will be randomly assigned by chance (like flipping a coin) to one of the two treatment groups: * Phase 2a Dose Finding: Modakafusp Alfa (DL1) + Daratumumab * Phase 2a Dose Finding: Modakafusp Alfa (DL2) + Daratumumab This multi-center trial will be conducted worldwide. The overall time to participate in this study is approximately 60 months. Participants who discontinue study drug treatment for reasons other than progressive disease will continue progression-free survival (PFS) follow-up every 4 weeks from the end of treatment (EOT) visit until the occurrence of progressive disease, death, the start of subsequent systemic antineoplastic therapy, study termination, whichever occurs first.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
Cedars-Sinai Medical Center, Los Angeles, California, United States
Fort Wayne Medical Oncology and Hematology, Inc, Fort Wayne, Indiana, United States
HCA Midwest Health (Midwest Ventures Group HCA MidAmerica Division), Overland Park, Kansas, United States
Tulane University Health Sciences Center, New Orleans, Louisiana, United States
Floating Hospital for Children at Tufts Medical Center, Boston, Massachusetts, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Summit Medical Group PA, Florham Park, New Jersey, United States
New York Cancer and Blood Specialists, Bay Shore, New York, United States
Stony Brook University Hospital, Stony Brook, New York, United States
University of Cincinnati - Vontz Center for Molecular Studies, Cincinnati, Ohio, United States
Tranquil Clinical Research, Webster, Texas, United States
Concord Repatriation General Hospital, Concord, New South Wales, Australia
The Alfred Hospital, Melbourne, Victoria, Australia
Centre Hospitalier Universitaire De Sherbrooke (CHUS) - Centre de Recherche Clinique Etienne-Le Bel (CRCELB) Hopital Fleurimont, Sherbrooke, Quebec, Canada
Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, China
Wuhan Union Hospital, Wuhan, Hubei, China
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, Tianjin, China
Zhejiang University School of Medicine - The First Affiliated Hospital (Zhejiang Provincial First Hospital), Hangzhou, Zhejiang, China
CHRU Lille, Lille, Hauts-de-France, France
Institut Paoli-Calmettes, Marseille, Provence-Alpes-Cote d'Azur, France
Chonnam National University Hwasun Hospital, Hwasun, Jeollanam-do, Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
The Catholic University of Korea, Seoul St. Marys Hospital, Seoul, , Korea, Republic of
Hospital Universitario Vall d'Hebron, Barcelona, , Spain
Fundacion Instituto de Estudios Ciencias de la Salud de Castilla y Leon-Investigacion Biomedica de Salamanca (IBSAL), Salamanca, , Spain
Contact Details
Name: Study Director
Affiliation: Takeda
Role: STUDY_DIRECTOR
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