Plasma Cell Myeloma Refractory study: SAR446523
Official title A Study to Investigate the Safety and Efficacy of SAR446523 Injected Subcutaneously in Adult Participants With Relapsed/Refractory Myeloma
ClinicalTrials.gov ID: NCT06630806
What this study is testing
What is SAR446523?
an investigational subcutaneous injectable medicine being studied as a potential treatment for refractory plasma cell myeloma
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether SAR446523 is safe and how well it works in adults with relapsed or refractory myeloma.
- Who it's for
- You may be able to join if you are an adult with relapsed or refractory multiple myeloma.
- What's involved
- You will receive a subcutaneous injection of SAR446523. In the first part, doctors will try different amounts to find a safe level. In the second part, you may be randomly assigned to one of two dose levels to see which works best.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants with a documented diagnosis of multiple myeloma (MM) with measurable disease.
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in...
- Participants must have received at least 3 prior lines of antimyeloma therapy, and must be either relapsed or refractory to the above therapies, or...
- Note: In Part A, prior exposure to anti g-protein-coupled receptor, class c, group 5, member d (GPRC5D) therapy and anti B-cell maturation antigen...
- Participants must have received at least 3 prior lines of antimyeloma therapy and be either relapsed or refractory to immunomodulator (IMiD)...
You likely can't join if
- -Participants are excluded from the study if any of the following criteria apply: Eastern cooperative oncology group performance status (ECOG PS) of...
- Primary systemic and localized amyloid light chain (AL) amyloidosis, active polyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin...
- Systemic antimyeloma treatment within 14 days before the first study treatment administration.
- Prior treatment with natural killer (NK)-cell engaging therapy (such as monoclonal antibody with antibody-dependent cellular cytotoxicity as primary...
- Inadequate organ and marrow function.
- Participants with significant concomitant illness. The above information is not intended to contain all considerations relevant to the potential...
See the full eligibility criteria
- Participants with a documented diagnosis of multiple myeloma (MM) with measurable disease.
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Dose escalation (Part A)
- Participants must have received at least 3 prior lines of antimyeloma therapy, and must be either relapsed or refractory to the above therapies, or are intolerant to them.
- Note: In Part A, prior exposure to anti g-protein-coupled receptor, class c, group 5, member d (GPRC5D) therapy and anti B-cell maturation antigen (BCMA) therapy is allowed. Dose optimization (Part B)
- Participants must have received at least 3 prior lines of antimyeloma therapy and be either relapsed or refractory to immunomodulator (IMiD), proteasome inhibitor (PI), anti CD38 monoclonal antibody (mAb), and anti BCMA...
- Note: In Part B, prior exposure to antiGPRC5D therapy is not allowed.
- -Participants are excluded from the study if any of the following criteria apply: Eastern cooperative oncology group performance status (ECOG PS) of 2 or greater.
- Primary systemic and localized amyloid light chain (AL) amyloidosis, active polyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin changes (POEMS) syndrome, active plasma cell leukemia.
- Systemic antimyeloma treatment within 14 days before the first study treatment administration.
- Prior treatment with natural killer (NK)-cell engaging therapy (such as monoclonal antibody with antibody-dependent cellular cytotoxicity as primary mechanism of action) within 90 days of the first study treatment...
- Inadequate organ and marrow function.
- Participants with significant concomitant illness. The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.
The study team makes the final eligibility decision.
Where it is enrolling
- Phoenix, Arizona, United States
- Jacksonville, Florida, United States
- Rochester, Minnesota, United States
- Hackensack, New Jersey, United States
- Philadelphia, Pennsylvania, United States
- Wollongong, New South Wales, Australia
- Melbourne, Victoria, Australia
- Vancouver, British Columbia, Canada
- Montreal, Quebec, Canada
- Sherbrooke, Quebec, Canada
- Lille, France
- Nantes, France
- Tel Aviv, Malopolskie, Israel
- Haifa, Israel
- Jerusalem, Israel
- Torette, Ancona, Italy
- Rozzano, Milano, Italy
- Barcelona, Barcelona [Barcelona], Spain
- Madrid, Spain
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, but 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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Phoenix, Arizona, United States; Jacksonville, Florida, United States; Rochester, Minnesota, United States; Hackensack, New Jersey, United States; Philadelphia, Pennsylvania, United States; Wollongong, New South Wales, Australia and 13 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.