Phase 1b Safety and Tolerability study of Modakafusp Alfa as combination therapy in patients with MM
Research type
Research Study
Full title
A Phase 1b Open-label Study to Evaluate the Safety and Tolerability of Intravenous Modakafusp Alfa as Part of Combination Therapy in Adult Patients With Multiple Myeloma
IRAS ID
1006557
Contact name
Isha Majmudar
Contact email
Sponsor organisation
Takeda Development Center Americas, Inc.
Eudract number
2022-001418-20
Research summary
This is a global multicenter, open-label, phase 1b study. The purpose of this study is to test the safety and tolerability, the anti-myeloma activity, and to identify the most appropriate dose of the research study drug, modakafusp alfa, in combination with other myeloma treatments for further evaluation.
Participants will be enrolled for approximately 24 to 30 months and will continue to follow-up phase for a total duration of approximately 5 years. Approximately 144 participants will be enrolled at approximately 50 sites globally. Study will be conducted in 3 Groups. Participants will be assigned to a specific arm within a group, based on the status of their disease.
Group 1: In this group, newly diagnosed multiple myeloma (NDMM) participants who are in maintenance therapy after an autologous stem cells transplantation and still have detectable myeloma disease, will be enrolled. This group contains only one arm, Arm 1, where modakafusp alfa will be given together with lenalidomide.
Group 2: will enroll relapsed/refractory multiple myeloma (RRMM) participants as part of combination therapy with a combination agent. This group contains three arms (Arms 2, 3 and 4) with a different combination therapy. The doublet combination is designed to determine the recommended dose of modakafusp alfa and the combination agents including, but not limited to, bortezomib, pomalidomide and carfilzomib.
Group 3: Once safety and tolerability of modakafusp alfa as part of combination therapy in group 2 is determined, participants with relapsed/refractory multiple myeloma (RRMM) will be enrolled in to group 3, to determine the safety and tolerability of modakafusp alfa as part of 2 drugs + modakafusp alfa (triplet) combination therapy. This group contains four arms (Arms A, B, C, and D). The triplet combination is designed to determine the most appropriate dose of modakafusp alfa (TAK-573) in combination with two combination agents for further evaluation.REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
22/EE/0295
Date of REC Opinion
3 May 2023
REC opinion
Further Information Favourable Opinion