A Study of Modakafusp Alfa on Adult Participants With Relapsed/Refractory Multiple Myeloma

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.

Timeline

Start

2017-10-04

Primary completion

2024-07-01

Completion

2024-11-07

Publications

• Holstein SA, Atrash S, Mian H, Dimopoulos MA, Schjesvold F, Popat R, Shah N, Gatt ME, Gocke CB, Frenzel L, Touzeau C, Beksac M, Manier S, Magen H, Travis P, Nadeem O, Suryanarayan K, Li C, Li S, Nelson A, Cherepanov D, Parot X, Vogl DT. A phase 2 randomized study of modakafusp alfa as a single agent for patients with relapsed/refractory multiple myeloma. Blood. 2025 Aug 28;146(9):1051-1064. doi: 10.1182/blood.2024027873.
• Vogl DT, Atrash S, Holstein SA, Nadeem O, Benson D, Chaudry M, Biran N, Suryanarayan K, Li C, Liu Y, Collins S, Parot X, Kaufman JL. Targeted interferon therapy with modakafusp alfa for relapsed or refractory multiple myeloma. Blood. 2025 Feb 27;145(9):944-955. doi: 10.1182/blood.2024026124.

Drugs

Indications