BridgeMD
A study to investigate the clinical benefit of isatuximab in combination with bortezomib, lenalidomide and dexamethasone in adults with newly diagnosed multiple myeloma not eligible for transplant
EU CTIS ID: 2024-514417-34-00
What this study is testing
To demonstrate the benefit of isatuximab in combination with bortezomib, lenalidomide, and dexamethasone in the prolongation of progression free survival (PFS) as compared to bortezomib, lenalidomide, and dexamethasone, in participants with newly diagnosed multiple myeloma (NDMM) not eligible for transplant.
- 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
- -Multiple myeloma (International Myeloma Working Group [IMWG] criteria).
- -Newly diagnosed multiple myeloma not eligible for transplant due to age (≥ 65 years) or participants < 65 years with comorbidities impacting possibility of transplant.
- -Evidence of measurable disease.
- -Written informed consent
You likely can't join if
- -Age <18 years.
- -Prior treatment for multiple myeloma.
- -Any other prior or ongoing disease/health conditions incompatible with the study objectives.
- -Organ function values not met.
- -Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) > 2.
- -Hypersensitivity to the study medications.
See the full eligibility criteria
- -Multiple myeloma (International Myeloma Working Group [IMWG] criteria).
- -Newly diagnosed multiple myeloma not eligible for transplant due to age (≥ 65 years) or participants < 65 years with comorbidities impacting possibility of transplant.
- -Evidence of measurable disease.
- -Written informed consent
- -Age <18 years.
- -Prior treatment for multiple myeloma.
- -Any other prior or ongoing disease/health conditions incompatible with the study objectives.
- -Organ function values not met.
- -Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) > 2.
- -Hypersensitivity to the study medications.
- -Pregnant, breastfeeding, or woman of child bearing potential unwilling to use recommended contraception methods.
- -Male participants who disagree to follow the study contraceptive counseling.
The study team makes the final eligibility decision.
Where it's taking place
- China
- Turkey
- Mexico
- United States
- Taiwan
- New Zealand
- Russian Federation
- Australia
- Japan
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, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include China; Turkey; Mexico; United States; Taiwan; New Zealand and 3 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.