Health TrialsbyHealthPanel

Study of Belantamab Mafodotin With Carfilzomib, Pomalidomide, and Dexamethasone in Relapsed Multiple Myeloma

ConditionsMultiple MyelomaRelapse Multiple Myeloma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Chicago

About this trial

Doctors leading this study hope to learn if the combination of belantamab mafodotin, carfilzomib, pomalidomide, and dexamethasone is effective and safe when given to people who have multiple myeloma that has gotten worse and is not responding to standard drugs that are used for treating multiple myeloma, including chimeric antigen receptor T-cell therapy.

Participation in this research will last about 6 -24 months, but it may be less or more depending on your response to treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subject must be ≥ 18 years of age.

Life expectancy of more than three months.

Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

Subject must have adequate organ function, defined by clinically confirmed lab values set by the study team.

Disqualifiers

Waldenström's macroglobulinemia, systemic amyloidosis, POEMS syndrome, or plasma cell leukemia at the time of screening.

Radiotherapy to multiple sites within 3 weeks before start of protocol treatment (localized radiotherapy to a single site 1 week before start is permissible).

Subject must not have used an investigational drug or approved systemic anti-myeloma therapy (including systemic steroids) within 14 days preceding the first dose of study drug.

Prior refractory status to belantamab mafodotin. Concurrent Conditions

Trial design

Design model

Parallel

Treatments tested in this trial

  • Belantamab mafodotin

    Drug

    Cycles 1, 3, 5, 7, etc. (odd numbered cycles): 1.9 mg/kg IV on Day 1 (28-day cycles)

  • Carfilzomib

    Drug

    Cycle 1: 20 mg/m2 on Day 1, then 56 mg/m2 on Days 8/15 Cycles 2-8: 56 mg/m2 on Days 1/8/15 Cycles 9+: 56 mg/m2 on Days 1/15

  • Pomalidomide

    Drug

    3 mg Day 1-21 of 28-day Cycle

  • Dexamethasone

    Drug

    Cycles 1-4: 40 mg Days 1/8/15/22 Cycles 5+: 20 mg Days 1/8/15/22

Treatment groups

83 Participants
are divided into 2 treatment groups
Group A: Cohort 1: No Prior CAR T-Cell TherapyExperimental treatment 4 interventions
Group B: Cohort 2: Prior CAR T-Cell TherapyExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Rate of Very Good Partial Response (No Prior CAR T-Cell Therapy Cohort)

No prior CAR T-cell therapy cohort: Rate of very good partial response (VGPR) or better after 6 cycles according to the 2016 International Myeloma Working Group (IMWG) Response Criteria by Independent Review Committee (IRC).

Time frame
6-24 months
2

Rate of Overall Response (Prior CAR T-Cell Therapy Cohort)

Prior CAR T-cell therapy cohort: Rate of overall response (ORR) as determined by investigator assessment.

Time frame
6-24 months

Secondary outcomes

1

Overall Response Rate

Overall response rate as determined by the 2016 International Myeloma Working Group (IMWG) Response Criteria by Independent Review Committee (IRC) and investigator assessment.

Time frame
6-24 months
2

Minimal Residual Disease Negativity Rate

Minimal Residual Disease (MRD) negativity rate as assessed by next generation sequencing (limit of detection \< 10-5).

Time frame
6-24 months
3

Progression-Free Survival

Progression-free survival of participants as determined by investigator assessment.

Time frame
6-24 months
4

Overall Survival Among Participants

Overall survival of participants as determined by investigator assessment.

Time frame
6-24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Chicago

Lead sponsor

GlaxoSmithKline

Collaborator

Amgen

Collaborator

Source ClinicalTrials.gov
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