TERMINATED

Belantamab Mafadotin Maintenance Therapy After Salvage Autologous Hematopoietic Cell Transplantation in Patients With Relapse Refractory Multiple Myeloma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical research study is to learn if belantamab mafodotin (Blenrep) can help to prevent multiple myeloma (MM) from coming back after patients have had an autologous stem cell transplant (AutoSCT). The safety of this drug after transplant will also be studied

Official Title

Belantamab Mafadotin Maintenance Therapy After Salvage Autologous Hematopoietic Cell Transplantation in Patients With Relapse Refractory Multiple Myeloma

Quick Facts

Study Start:2023-01-05

Study Completion:2025-11-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT05065047

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Patients with relapsed or refractory multiple myeloma. Eligible patients will be enrolled in the protocol no less than 60 days and must be initiated no longer than 180 days (± 2 weeks) post ASCT. Patient's transplant may be either transplantation naïve or with a history of previous autologous transplant. 2. Patients who have had two or more lines of therapy consisting of at least one of three agents including a proteasome inhibitor or an immunomodulatory agent or an anti-CD38 targeting therapy. 3. Disease status, partial response, or better. 4. Age ≥ 18-year and ≤ 75-year. English and non-English speaking patients are eligible. 5. Platelet count ≥ 50,000/mm3 \& Hemoglobin ≥ 8 g/dL, ANC ≥ 1.0 × 109/L 6. Karnofsky Performance Status (KPS) \>70 (Appendix B.). 7. Adequate organ function (ALT ≤ 2.5 ULN; Total bilirubin ≤ 1.5 ULN or total bilirubin * 1.5 ULN with direct bilirubin ≤ 35%; estimated glomerular filtration rate ≥30 mL/min per 1.73 m2 8. Participants must not be pregnant or lactating 9. Female participants: contraceptive use should be consistent with institutional guidelines regarding the methods of contraception for those participating in clinical studies. 1. Is not a woman of childbearing potential (WOCBP) OR 2. Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \<1% per year), preferably with low user dependency (as described in Appendix C.), during the intervention period and for at least 4 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relation to the first dose of the study intervention. * Refrain from donating sperm * Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent.	* Established anti-retroviral therapy (ART) for at least 4 weeks and HIV viral load \<400 copies/mL * CD4+ T-cell (CD4+) counts ≥350 cells/uL * No history of AIDS-defining opportunistic infections within the last 12 months 14. Participant must not have presence of hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb) at screening or within 3 months prior to first dose of study treatment. Note: presence of Hep B surface antibody (HBsAb) indicating previous vaccination will not exclude a participant.

Inclusion Criteria

Exclusion Criteria

1. Patients with relapsed or refractory multiple myeloma. Eligible patients will be enrolled in the protocol no less than 60 days and must be initiated no longer than 180 days (± 2 weeks) post ASCT. Patient's transplant may be either transplantation naïve or with a history of previous autologous transplant.
2. Patients who have had two or more lines of therapy consisting of at least one of three agents including a proteasome inhibitor or an immunomodulatory agent or an anti-CD38 targeting therapy.
3. Disease status, partial response, or better.
4. Age ≥ 18-year and ≤ 75-year. English and non-English speaking patients are eligible.
5. Platelet count ≥ 50,000/mm3 \& Hemoglobin ≥ 8 g/dL, ANC ≥ 1.0 × 109/L
6. Karnofsky Performance Status (KPS) \>70 (Appendix B.).
7. Adequate organ function (ALT ≤ 2.5 ULN; Total bilirubin ≤ 1.5 ULN or total bilirubin
* 1.5 ULN with direct bilirubin ≤ 35%; estimated glomerular filtration rate ≥30 mL/min per 1.73 m2
8. Participants must not be pregnant or lactating
9. Female participants: contraceptive use should be consistent with institutional guidelines regarding the methods of contraception for those participating in clinical studies.
1. Is not a woman of childbearing potential (WOCBP) OR
2. Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \<1% per year), preferably with low user dependency (as described in Appendix C.), during the intervention period and for at least 4 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relation to the first dose of the study intervention.
* Refrain from donating sperm
* Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent.

* Established anti-retroviral therapy (ART) for at least 4 weeks and HIV viral load \<400 copies/mL
* CD4+ T-cell (CD4+) counts ≥350 cells/uL
* No history of AIDS-defining opportunistic infections within the last 12 months 14. Participant must not have presence of hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb) at screening or within 3 months prior to first dose of study treatment. Note: presence of Hep B surface antibody (HBsAb) indicating previous vaccination will not exclude a participant.

Contacts and Locations

Principal Investigator

Neeraj Saini, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Neeraj Saini, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-05

Study Completion Date2025-11-06

Study Record Updates

Study Start Date2023-01-05

Study Completion Date2025-11-06

Terms related to this study

Additional Relevant MeSH Terms

Multiple Myeloma