Isatuximab, Bela Maf, Pom, and Dex in Relapsed/Refractory Multiple Myeloma

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT05922501
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Isatuximab — DRUG
    An IgG1-derived monoclonal antibody that targets CD38 proteins, administered intravenously.
  • Belantamab mafodotin — DRUG
    An antibody-drug conjugate that is the combination of an antibody targeting BCMA and a drug, administered intravenously.
  • Pomalidomide — DRUG
    An immunomodulatory agent, capsule taken orally.
  • Dexamethasone — DRUG
    A glucocorticoid which is a substance that stops inflammation cause by immune system disorders, tablet taken orally.

Study Details

The main goal of this phase II study is to evaluate the overall response rate of isatuximab, belantamab mafodotin, pomalidomide, and dexamethasone in relapsed and refractory multiple myeloma. The study drugs provided for research purposes are isatuximab and belantamab mafodotin.

Key Dates

Start date
May 31, 2024
Status verified
Jan 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2030

Study Design

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

Arms

  • Experimental: Isatuximab + Belantamab mafodotin + Pomalidomide + Dexamethasone
    Isatuximab will be given once daily into your vein (by intravenous infusion) over about 30-60 minutes. This will occur during cycle 1 (cycle equals 28 days) on days 1, 8, 15, and 22 and cycle 2 and onwards days 1 and 15. Belantamab mafodotin will be given once every 8 weeks into your vein (by intravenous infusion) over about 60 minutes after completion of isatuximab infusion. Pomalidomide will be taken orally once daily during days 1-21 of each cycle. Dexamethasone will be taken orally once daily during days 1, 2, 8, 9, 15, 16, 22, and 23 of each cycle. Drug diaries will be provided to participants to document information about taking pomalidomide and dexamethasone.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: 4 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02215
Clifton C. Mo, MD
[email protected]
617-582-7969
Massachusetts General HospitalBostonMassachusetts02114
Andrew Yee, MD
[email protected]
617-724-4000

Find similar trials in Boston, MA

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Dana-Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MA

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