Status:
NOT_YET_RECRUITING
Trial of an Investigational Drug After Rejecting the Relapse of an Allogeneic Transplant
Lead Sponsor:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Conditions:
Multiple Myeloma
Allogeneic Stem Cell Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Most patients with multiple myeloma (MM) die due to relapse resistant to current treatment, including treatment with anti-B cell maturation antigen (BCMA) CAR-T cells. To overcome some of the potentia...
Detailed Description
This trial is a prospective phase I/II trial with a 3+3 design. Once Dose Limiting Toxicity is identified (up to a maximum dose of 6x106 CAR-T/kg divided over 2 days), phase II of the trial will begin...
Eligibility Criteria
Inclusion
- Patients \> 18 years old with a diagnosis of post-allogeneic transplant relapse multiple myeloma.
- Measurable disease at the time of screening
- Previous treatment with ≥2 lines before and/or after allogeneic transplant.
- Patients who are not receiving immunosuppressants at least 1 month before inclusion and who do not have active graft-versus-host disease.
- Eastern Cooperative Oncology Group functional status from 0 to 1.
- Life expectancy greater than 3 months (at the time of screening)
- Patients who give their consent by signing the Informed Consent document.
Exclusion
- Active systemic immunosuppressive treatment
- Patients who have previously received treatment with CAR-T Anti-BCMA.
- Absolute lymphocyte count \<0.2x109/L
- Previous neoplasm, except if it has been in complete remission \>3 years, with the exception of skin carcinoma (non-melanoma)
- Active infection requiring treatment.
- Active HIV, hepatitis B virus or hepatitis C virus infection.
- Uncontrolled medical illness.
- 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).
- Previous diagnosis of symptomatic amyloid light chain or primary amyloidosis or POEMS Syndrome.
- Pregnant or lactating women.
- Women of childbearing age, unable or unwilling to use highly effective contraceptive methods.
- 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.
- Contraindication to receive lymphodepleting chemotherapy.
- Patients with known hypersensitivity to the active ingredients or any of the excipients of the product to be infused.
Key Trial Info
Start Date :
December 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT05982275
Start Date
December 30 2024
End Date
December 31 2029
Last Update
May 14 2024
Active Locations (5)
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1
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain, 39008
2
Hospital Santa Creu i Sant Pau
Barcelona, Spain, 08025
3
Complejo asistencial universitario de Salamanca
Salamanca, Spain, 37007
4
José Antonio Pérez Simón
Seville, Spain, 41011