An Open-label, Randomized Phase Ib/II Study Evaluating Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants with Relapsed or Refractory Multiple Myeloma

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-503689-21-00

Acronym

BP43437

Enrollment

Registered

2023-10-19

Start date

2023-12-05

Completion date

2025-04-14

Last updated

2024-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple myeloma (MM)

Brief summary

1. Incidence and severity of adverse events (AEs), with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0) and of cytokine release syndrome (CRS) and immune effector cell associated neurotoxicity syndrome (ICANS) according to American Society of Transplantation and Cellular Therapy (ASTCT) Consensus Grading, 2. Objective response rate (ORR), 3. Complete response (CR)/stringent complete response (sCR) rate, 4. Rate of very good partial response (VGPR) or better

Detailed description

1. Progression-free survival (PFS), 2. Duration of response (DoR) for participants who achieve a partial response (PR) or better, 3. Time to first response, 4. Time to best response, 5. Overall survival (OS), 6. To assess the serum concentrations and PK parameters of forimtamig, 7. Presence of anti-drug antibodies (ADAs) during the study

Interventions

DRUGDIPHENHYDRAMINE

DRUGACTEMRA

DRUGRO7425781

DRUGDEXAMETHASONE

DRUGDARZALEX 1800 mg solution for injection

DRUGKyprolis 30 mg powder for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1. Incidence and severity of adverse events (AEs), with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0) and of cytokine release syndrome (CRS) and immune effector cell associated neurotoxicity syndrome (ICANS) according to American Society of Transplantation and Cellular Therapy (ASTCT) Consensus Grading, 2. Objective response rate (ORR), 3. Complete response (CR)/stringent complete response (sCR) rate, 4. Rate of very good partial response (VGPR) or better	—

Measure

Time frame

—

Secondary

Measure	Time frame
1. Progression-free survival (PFS), 2. Duration of response (DoR) for participants who achieve a partial response (PR) or better, 3. Time to first response, 4. Time to best response, 5. Overall survival (OS), 6. To assess the serum concentrations and PK parameters of forimtamig, 7. Presence of anti-drug antibodies (ADAs) during the study	—

Countries

Denmark, France, Germany, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026