BridgeMD
A Study to Evaluate Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants with Relapsed or Refractory Multiple Myeloma
EU CTIS ID: 2023-503689-21-00
What this study is testing
To evaluate the safety and tolerability of forimtamig when given alone or in combination To evaluate the preliminary anti-tumor activity of forimtamig when given alone or in combination based on objective response rate (ORR), complete response (CR)/stringent complete response (sCR) rate, rate of very good partial response (VGPR) or better
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Agreement to provide protocol-specific bone marrow biopsy and aspirate samples
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Life expectancy of at least 12 weeks
- Documented diagnosis of MM according to the International Myeloma Working Group (IMWG) diagnostic criteria
- Evidence of progressive disease based on Investigator’s determination of response by IMWG criteria on or after last dosing regimen
- Participants with r/r MM who previously received therapy, including an immunomodulatory drugs (IMiDs) and a proteasome inhibitor (PI). Both anti-CD38 naïve and anti-CD38 exposed/refractory participants are allowed
You likely can't join if
- Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the last dose of forimtamig, tocilizumab, or carfilzomib, or 102 days after the last dose of daratumumab
- Plasma cell leukemia with circulating plasma cell count = 5% or >500/µL
- Waldenström’s macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloid light-chain amyloidosis
- Participants with current amyloidosis (e.g., positive Congo Red stain or equivalent in tissue biopsy)
- Participants with myelodysplastic syndrome
- Participants with (extramedullary) lesions in proximity of vital organs that may develop sudden decompensation/deterioration in the setting of a tumor flare. Participants may be eligible after discussion with the Medical Monitor
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Canada
- Korea, Republic of
- New Zealand
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Canada; Korea, Republic of; New Zealand; Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.