Health TrialsbyHealthPanel

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

ConditionsRelapsed CancerRefractory Multiple MyelomaMultiple Myeloma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant has given voluntary signed written informed consent before performance of any study-related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to their future medical care.

Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (see Appendix A).

Age ≥ 18 years

Serum monoclonal protein ≥ 0.5 g/dL. Patients with IgD disease and lower amounts of monoclonal protein may be permitted to enroll with PI approval

Disqualifiers

Participant must not have had current corneal epithelial disease except mild changes in corneal epithelium.

Participant must not use contact lenses while participating in this study.

Participants who have had myeloma therapy or investigational drug within 2 weeks prior to start of treatment or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier.

Participants who are receiving any investigational agents.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Isatuximab + Belantamab mafodotin + Pomalidomide + DexamethasoneExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Overall Response Rate (ORR)

Evaluated per International Myeloma Working Group Response Criteria

Time frame
4 weeks

Secondary outcomes

1

Number of Adverse Events

Adverse events will be classified and graded according to the CTCAE v.5.0. Frequencies of adverse events will be summarized on all patients who receive any study drug.

Time frame
4 weeks
2

Progression Free Survival (PFS)

PFS is defined as the time from start of treatment to disease progression or death from any cause. Patients who have not progressed or died are censored at the date last known progression-free. This is estimated using the Kaplan-Meier method.

Time frame
The time from start of treatment to disease progression or death from any cause, for up to 10 years. Patients who have not progressed or died are censored at the date last known progression-free.
3

Overall survival (OS)

OS is defined as the time from start of treatment to death due to any cause or censored at date last known alive. This is estimated using the Kaplan-Meier method.

Time frame
4 weeks

Other outcomes

Sponsors and contacts

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

Massachusetts General Hospital

Lead sponsor

Sanofi

Collaborator

GlaxoSmithKline

Collaborator

Source ClinicalTrials.gov
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