A Collaborative Community Effort Using Belantamab Mafodotin in Relapsed/Refractory Myeloma

Part of paid clinical trials in Clayton, North Carolina.

Sponsor
Cristiana Costa Chase, DO
Study ID
NCT05874193
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Belantamab mafodotin — DRUG
    Belantamab mafodotin 2.5mg/kg in 42-day cycles. Every 6 weeks until PD, unacceptable toxicity or withdrawal of consent, whichever comes first

Study Details

This is a research study to find out if a drug called belantamab mafodotin in combination with dexamethasone, a steroid, can be safely and effectively given in the community setting. Belantamab mafodotin (BLENREP) was approved in the US in August 2020 under an FDA program called accelerated approval. In November 2022, belantamab mafodotin was removed from the market because a study to further confirm its activity in relapsed/refractory multiple myeloma did not deliver a supporting result. However, this confirmatory study demonstrated that some patients may still benefit from treatment with belantamab mafodotin, and that this benefit can be long lasting. Belantamab mafodotin is often given at large academic medical centers every 3 weeks. This study will assess whether it is possible to administer belantamab in the community setting every 6 weeks. It is unknown if administering belantamab every 6 weeks versus every 3 weeks will result in improved safety and/or reduced efficacy.

Key Dates

Start date
May 31, 2026
Status verified
Dec 2025
Primary completion
May 31, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
33 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment every 6 weeks
    Treatment every 6 weeks

Primary Outcome Measure

Assess the feasibility of providing Belantamab mafodotin in a heavily pretreated, rural population of patients with multiple myeloma receiving this study regimen every 6 weeks instead of every 3-week cycles. [ Time Frame: From registration until stopped early due to excess unacceptable toxicity and/or lack of efficacy. Subjects followed for 2 years from end of treatment ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Johnston Hematology and Oncology of ClaytonClaytonNorth Carolina27570
Maria Fochesato, RN, OCN
[email protected]
984-227-9875
Maria Parham HospitalHendersonNorth Carolina27536
Maria Fochesato, RN, OCN
[email protected]
984-227-9578
Scotland Health Care SystemLaurinburgNorth Carolina28352
Maria Fochesato, RN, OCN
[email protected]
984-227-9578
UNC Health SoutheasternLumbertonNorth Carolina28358
Maria Fochesato, RN, OCN
[email protected]
984-227-9578
Johnston Cancer CenterSmithfieldNorth Carolina27577
Maria Fochesato, RN, OCN
[email protected]
984-227-9875

Find similar trials in Clayton, NC

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Johnston Hematology and Oncology of Clayton· Clayton, NCMaria Parham Hospital· Henderson, NCScotland Health Care System· Laurinburg, NCUNC Health Southeastern· Lumberton, NCJohnston Cancer Center· Smithfield, NC

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