BridgeMD
SC versus IV isatuximab in combination with pomalidomide and dexamethasone in RRMM
EU CTIS ID: 2023-508869-32-00
What this study is testing
- Demonstrate the efficacy non-inferiority between isatuximab subcutaneous (SC) and isatuximab intravenous (IV) in combination with pomalidomide and dexamethasone (Pd) - Demonstrate the pharmacokinetic (PK) non-inferiority between isatuximab SC and isatuximab IV in combination with Pd
- Therapeutic confirmatory (Phase III)
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
- -Participants with multiple myeloma who have received at least one prior line of anti- myeloma therapy, which must include lenalidomide and a proteasome inhibitor given alone or in combination.
- -Measurable serum M-protein (≥ 0.5 g/dL) and/or urine M-protein (≥ 200 mg/24 hours) and/or serum free light chain (FLC) assay (Involved FLC assay ≥10 mg/dL and abnormal serum FLC ratio (<0.26 or >1.65)).
You likely can't join if
- -Primary refractory multiple myeloma participants
- -Know active Hepatitis A infection. Current active or chronic hepatitis B (HBV) or hepatitis C (HCV) infection. Participants with chronic HBV or HCV disease that is controlled under antiviral therapy are allowed.
- -Women of childbearing potential or male participant with women of childbearing potential who do not agree to use highly effective method of birth control
- -Participants with prior anti-CD38 treatment: (a) administered less than 9 months before randomization or, (b) intolerant to the anti-CD38 previously received
- -Prior therapy with pomalidomide
- Participants with inadequate biological tests.
See the full eligibility criteria
- -Participants with multiple myeloma who have received at least one prior line of anti- myeloma therapy, which must include lenalidomide and a proteasome inhibitor given alone or in combination.
- -Measurable serum M-protein (≥ 0.5 g/dL) and/or urine M-protein (≥ 200 mg/24 hours) and/or serum free light chain (FLC) assay (Involved FLC assay ≥10 mg/dL and abnormal serum FLC ratio (<0.26 or >1.65)).
- -Primary refractory multiple myeloma participants
- -Know active Hepatitis A infection. Current active or chronic hepatitis B (HBV) or hepatitis C (HCV) infection. Participants with chronic HBV or HCV disease that is controlled under antiviral therapy are allowed.
- -Women of childbearing potential or male participant with women of childbearing potential who do not agree to use highly effective method of birth control
- -Participants with prior anti-CD38 treatment: (a) administered less than 9 months before randomization or, (b) intolerant to the anti-CD38 previously received
- -Prior therapy with pomalidomide
- Participants with inadequate biological tests.
- -Significant cardiac dysfunction
- - Participants diagnosed or treated for another malignancy within 3 years prior to randomization with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, and in situ malignancy, or low risk prostate cancer after curative therapy
- -Concomitant plasma cell leukemia
- -Active primary amyloid light -chain amyloidosis
- -Known acquired immunodeficiency syndrome (AIDS)-related illness or known human immunodeficiency virus (HIV) disease requiring antiviral treatment
The study team makes the final eligibility decision.
Where it's taking place
- Brazil
- China
- Australia
- Chile
- Canada
- United States
- Argentina
- Turkey
- Japan
- United Kingdom
- Taiwan
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, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brazil; China; Australia; Chile; Canada; United States and 5 more location(s). 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.