Trial of an Investigational Drug After Rejecting the Relapse of an Allogeneic Transplant

Launched by FUNDACIÓN PÚBLICA ANDALUZA PARA LA GESTIÓN DE LA INVESTIGACIÓN EN SEVILLA · Aug 1, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for patients with multiple myeloma (MM) who have experienced a relapse after receiving an allogeneic stem cell transplant. The focus is on an updated version of a therapy called Anti-BCMA CAR-T, which is designed to help patients whose cancer has not responded to existing treatments, including previous versions of CAR-T therapy. The trial is currently not recruiting participants, but it will eventually evaluate the safety and effectiveness of this new treatment.

To be eligible for this trial, participants must be at least 18 years old, have measurable multiple myeloma that has returned after a stem cell transplant, and have already tried at least two other treatment options. Patients should not be on immunosuppressive drugs for at least a month before joining the trial and must have a life expectancy of more than three months. Those who take part can expect to undergo treatment with this investigational drug and will be monitored closely for any side effects. It's important to note that there are specific health conditions and treatments that could prevent someone from participating, so interested individuals should discuss their eligibility with their healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients \> 18 years old with a diagnosis of post-allogeneic transplant relapse multiple myeloma.
• • 2. Measurable disease at the time of screening
• • 3. Previous treatment with ≥2 lines before and/or after allogeneic transplant.
• • 4. Patients who are not receiving immunosuppressants at least 1 month before inclusion and who do not have active graft-versus-host disease.
• • 5. Eastern Cooperative Oncology Group functional status from 0 to 1.
• • 6. Life expectancy greater than 3 months (at the time of screening)
• • 7. Patients who give their consent by signing the Informed Consent document.
• Exclusion Criteria:
• • 1. Active systemic immunosuppressive treatment
• • 2. Patients who have previously received treatment with CAR-T Anti-BCMA.
• • 3. Absolute lymphocyte count \<0.2x109/L
• • 4. Previous neoplasm, except if it has been in complete remission \>3 years, with the exception of skin carcinoma (non-melanoma)
• • 5. Active infection requiring treatment.
• • 6. Active HIV, hepatitis B virus or hepatitis C virus infection.
• • 7. Uncontrolled medical illness.
• • 8. Severe organic disease that meets any of the following criteria: left ventricular ejection fraction \<40%, carbon monoxide diffusion test \<40%, glomerular filtration rate \<50 ml/min, bilirubin \>3 normal value (except Gilbert syndrome).
• • 9. Previous diagnosis of symptomatic amyloid light chain or primary amyloidosis or POEMS Syndrome.
• • 10. Pregnant or lactating women.
• • 11. Women of childbearing age, unable or unwilling to use highly effective contraceptive methods.
• • 12. Men who cannot or do not wish to use highly effective contraceptive methods. The partner of the male participants, if they are women of childbearing age, must also use highly effective contraceptive methods during the study period.
• • 13. Contraindication to receive lymphodepleting chemotherapy.
• • 14. Patients with known hypersensitivity to the active ingredients or any of the excipients of the product to be infused.