A Study of Modakafusp Alfa on Adult Participants With Relapsed/Refractory Multiple Myeloma
NCT03215030 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 272
Last updated 2026-01-29
Summary
The main aims of this 3-part study are as follows:
Part 1: To determine any side effects from modakafusp alfa single treatment and how often they occur. The dose of modakafusp alfa will be increased a little at a time until the highest dose that does not cause harmful side effects is found.
Part 2: To assess clinical activity of one or more dosing schedules of modakafusp alfa alone in participants with relapsed/refractory multiple myeloma. Dexamethasone standard dose will be administered with one or more selected dose of modakafusp alfa in selected group of participants.
Part 3: To find the optimal dose with the more favorable risk-benefit profile of modakafusp alfa.
Participants will receive modakafusp alfa at one of two doses which will be given through a vein.
Conditions
Interventions
- DRUG
-
Dexamethasone.
- DRUG
-
Modakafusp alfa
Modakafusp alfa intravenous infusion.
Sponsors & Collaborators
-
Teva Branded Pharmaceutical Products R&D LLC
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-10-04
- Primary Completion
- 2024-07-01
- Completion
- 2024-11-07
- FDA Drug
- Yes
Countries
- United States
- Canada
- China
- France
- Germany
- Greece
- Israel
- Italy
- Japan
- Norway
- Puerto Rico
- South Korea
- Spain
- Taiwan
- Turkey (Türkiye)
- United Kingdom
Study Locations
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