CAR-T in Relapsed/Refractory Multiple Myeloma

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDr. Zaineb Akram

About this trial

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. Current therapeutic strategies include several classes of drugs, each working through different mechanisms. Proteasome inhibitors (PIs) disrupt the protein degradation process within myeloma cells, thereby promoting their death. Immunomodulatory drugs (IMiDs) modulate the immune system and inhibit tumor growth by enhancing the body's natural anti-cancer responses. Monoclonal antibodies specifically target cancer cells, marking them for destruction by the immune system. In cases where patients are eligible, autologous stem cell transplantation remains a viable option, offering the potential for long-term remission by replacing damaged bone marrow with healthy stem cells from the patient's own body.

Despite these advancements, multiple myeloma continues to present significant challenges, as it often recurs even after initial successful treatment and remains an incurable disease. This highlights the urgent need for innovative therapeutic strategies that can effectively address resistance to existing treatments, ultimately aiming to improve patient outcomes and survival rates.

Eligibility criteria

Qualifiers

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 hematopoietic stem cell transplant and with or without maintenance therapy is considered a single line of therapy.

Measurable disease at Screening as per IMWG criteria.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • CAR-T

Treatment groups

10 Participants
are divided into 1 treatment group

Sponsors and collaborators

Dr. Zaineb Akram

Lead sponsor

National Institute of Blood and Marrow Transplant (NIBMT), Pakistan

Sponsor institution