Pembrolizumab, Belantamab and Dexamethasone in Refractory Multiple Myeloma.

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Hackensack Meridian Health
Study ID
NCT05493618
Phase
PHASE1/PHASE2
Status
Withdrawn

Conditions

  • Multiple Myeloma, Refractory

Eligibility Criteria

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

Interventions

  • Pembrolizumab — DRUG
    Pembrolizumab 200 mg IV q3 weeks until unacceptable toxicity or disease progression for up to 2 years (35 cycles).
  • Belantamab mafodotin — DRUG
    Belantamab 2.5 mg/kg IV q3 weeks until unacceptable toxicity or disease progression for up to 2 years (35 cycles).
  • Dexamethasone — DRUG
    Dexamethasone 40 mg IV q3 weeks (20 mg if patient \>75) until unacceptable toxicity or disease progression for up to 2 years (35 cycles).

Study Details

This is a single arm, multi-institution (1) Hackensack Meridian Health at Hackensack, New Jersey (NJ) (2) Jersey Shore Medical Center, Neptune, NJ and (3) Georgetown/Lombardi Cancer Center) phase II study of the combination of pembrolizumab, belantamab, and dexamethasone in patients with triple class refractory multiple myeloma.

Key Dates

Start date
Dec 31, 2022
Status verified
Jan 2023
Primary completion
Nov 30, 2025
Completion
Nov 30, 2025

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Single-arm, multi-institution
    Study Arm: Pembrolizumab 200 mg IV q3 weeks Belantamab 2.5 mg/kg IV q3 weeks. Dex 40 mg IV q3 weeks (20 mg if patient \>75) Treatment will be administered on a 21-day cycle and will be continued until unacceptable toxicity or disease progression for up to 2 years (35 cycles)

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: 2 years ]

Locations (3)

FacilityCityStateZIPSite coordinators
Lombardi Comprehensive Cancer Center, Georgetown UniversityWashington D.C.District of Columbia20007-
John Theurer Cancer Center, Hackensack Meridian HealthHackensackNew Jersey07410-
Jersey Shore Medical CenterNeptune CityNew Jersey07753-

Find similar trials in Washington D.C., DC

By research site
Lombardi Comprehensive Cancer Center, Georgetown University· Washington D.C., DCJohn Theurer Cancer Center, Hackensack Meridian Health· Hackensack, NJJersey Shore Medical Center· Neptune City, NJ

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