Trial of an investigational drug after the rejection of an allogeneic transplant.

Phase 1

• Conditions: Multiple myeloma.; MedDRA version: 21.1Level: LLTClassification code: 10067095Term: Multiple myeloma progression Class: 10029104; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2022-503063-15-00
• Lead Sponsor: Fundacion Publica Andaluza para la Gestion de la Investigacion en Salud de Sevilla (FISEVI)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-08
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. Patients > 18 years old with a diagnosis of post-allogeneic transplant relapse multiple myeloma. 2. Medical illness 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 GVHD. 5. ECOG functional status from 0 to 1. 6. Life expectancy greater than 3 months 7. Patients who give their consent by signing the Informed Consent document.

Exclusion Criteria

1. Active systemic immunosuppressive therapy. 2. Patients who have previously received CAR-T Anti-BCMA treatment. Patients who have received another type of anti-BCMA therapy will not be excluded, although in this case the positivity for BCMA in myeloma cells must be confirmed at the time of inclusion. 3. Absolute lymphocyte count <0.2x109/L. 4. Previous malignancy, except if in complete remission >3 years, with the exception of cutaneous carcinoma (non-melanoma). 5. Active infection requiring treatment. 6. Active HIV, HBV, or HCV infection. 7. Uncontrolled medical illness. 8. Severe organic disease that meets any of the following criteria: EF <40%, DLCO < 40%, GFR < 50 ml/min, bilirubin > 3 NV (except Gilbert's syndrome). 9. Previous diagnosis of symptomatic AL amyloidosis or POEMS syndrome. 10. Pregnant or lactating women. 11. Women of childbearing potential who are unable or unwilling to use highly effective contraceptive methods 12. Men unable or unwilling to use highly effective contraceptive methods 13. Contraindication to receive lymphodepletive chemotherapy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified