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New treatment option for Multiple Myeloma Refractory
Official title CAR-T in Relapsed/Refractory Multiple Myeloma
ClinicalTrials.gov ID: NCT07689058
What this study is testing
What is CAR-T?
CAR-T is an investigational medicine, being studied as a potential treatment for multiple myeloma refractory.
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
- The treatment options for multiple myeloma have evolved significantly over the years, providing patients with a range of therapies tailored to their specific circumstances. The choice of treatment often hinges on various factors, including the aggressiveness of the disease, individual prognostic indicators like genetic markers, the overall physical condition of the patient, and any pre-existing health issues that may affect treatment decisions.
- Phase 2: a mid-size study of how well it works
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
- Male and female participants of age 18 years and above.
- Patients with a confirmed diagnosis of multiple myeloma according to IMWG diagnostic criteria.
- Received at least 3 prior multiple myeloma treatment lines of therapy or are double refractory to an IMiD and PI (refractory multiple myeloma as...
- Measurable disease at Screening as per IMWG criteria.
- ECOG Performance Status grade of 0 to 2.
You likely can't join if
- 1\. Patients who will meet any of the following criteria will not be eligible to participate in the study.
- Prior treatment with CAR-T therapy directed at any target. Any therapy that is targeted to BCMA.
- Known active, or prior history of central nervous system (CNS) involvement, or exhibits clinical signs of meningeal involvement of multiple myeloma.
- Stroke or seizure within 6 months of signing the ICF.
- Uncontrolled active infection, including uncontrolled bacterial or fungal infection; active uncontrolled HBV/HCV/HIV.
- Clinically significant cardiac disease (e.g., NYHA III/IV, recent MI), or severe pulmonary disease.
See the full eligibility criteria
- Male and female participants of age 18 years and above.
- Patients with a confirmed diagnosis of multiple myeloma according to IMWG diagnostic criteria.
- Received at least 3 prior multiple myeloma treatment lines of therapy or are double refractory to an IMiD and PI (refractory multiple myeloma as defined by IMWG consensus criteria). Note: induction with or without...
- Measurable disease at Screening as per IMWG criteria.
- ECOG Performance Status grade of 0 to 2.
- Adequate organ function: ANC/platelets thresholds (unless cytopenias attributable to MM), LVEF ≥45%, adequate oxygenation; hepatic/renal criteria specified in Section 10.
- Negative pregnancy test for women of childbearing potential; agreement to effective contraception.
- Patients giving written informed consent to participate in the study after a full understanding of the implications and constraints of the study protocol.
- Understand the content of the ICF, and voluntarily sign the ICF (If the participant is unable to sign the ICF on their own due to illiteracy, an impartial witness is needed).
- The subject can understand the research process and is willing and able to comply with all research proposals and other requirements of the study.
- Willing and able to adhere to the prohibitions and restrictions specified in this protocol.
- 1\. Patients who will meet any of the following criteria will not be eligible to participate in the study.
- Prior treatment with CAR-T therapy directed at any target. Any therapy that is targeted to BCMA.
- Known active, or prior history of central nervous system (CNS) involvement, or exhibits clinical signs of meningeal involvement of multiple myeloma.
- Stroke or seizure within 6 months of signing the ICF.
- Uncontrolled active infection, including uncontrolled bacterial or fungal infection; active uncontrolled HBV/HCV/HIV.
- Clinically significant cardiac disease (e.g., NYHA III/IV, recent MI), or severe pulmonary disease.
- Recent allogeneic HSCT with active GVHD or ongoing immunosuppression.
- Pregnant or breast-feeding, or planning to become pregnant while enrolled in this study or within 1 year after receiving study treatment.
- Any other circumstances that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site, to understand informed consent, or any condition for which, in the...
The study team makes the final eligibility decision.
Where it's taking place
- Rawalpindi, Punjab Province, Pakistan
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rawalpindi, Punjab Province, Pakistan. 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 ClinicalTrials.gov; the study team decides eligibility.