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Alternate Doses and Dosing Schedules of Belantamab Mafodotin for Treatment of Triple-Class Refractory Multiple Myeloma

ConditionsRecurrent Multiple MyelomaRefractory Multiple Myeloma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

This phase II trial tests alternate doses and dosing schedules of belantamab mafodotin in treating patients with triple-class multiple myeloma that has come back (after a period of improvement) (recurrent) and/or does not respond to treatment (or that has not responded to previous treatment) (refractory). Belantamab mafodotin is a monoclonal antibody, belantamab, linked to a chemotherapy drug, mafodotin. Belantamab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as BCMA receptors, and delivers mafodotin to kill them. This trial may help researchers determine if alternate doses and dosing schedules work better in preventing certain side effects, such as eye toxicity, and treating patients with recurrent or refractory multiple myeloma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age >= 18 years

Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2

If patients have undergone stem cell transplantation (SCT), day 0 of SCT must be > 100 days prior to registration to be eligible for the study

Has had disease progression after >= 3 prior lines of anti-myeloma treatments including one proteasome inhibitor (eg. bortezomib, carfilzomib or ixazomib), one immunomodulatory agent (eg.thalidomide, lenalidomide or pomalidomide) and one anti-CD38 monoclonal antibody (eg.daratumumab or isatuximab)

Disqualifiers

Active plasma cell leukemia at the time of screening. Symptomatic amyloidosis, active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal plasmaproliferative disorder, myeloma protein, and skin changes), Waldenstrom Macroglobulinemia

Prior belantamab mafodotin therapy. However, patients with prior exposure to another non-belantamab mafodotin anti-BCMA agent such as an anti-BCMA CAR-T or anti-BCMA bispecific antibody will be allowed to participate in the study

Systemic active infection requiring treatment

Any unresolved toxicity >= grade 2 from previous treatment except for alopecia, or peripheral neuropathy up to grade 2

Trial design

Design model

Parallel

Treatments tested in this trial

  • Belantamab Mafodotin

    Biological/Vaccine

    Given IV

  • Biospecimen Collection

    Procedure/Surgery

    Undergo collection of blood samples

  • Bone Marrow Aspirate

    Procedure/Surgery

    Undergo bone marrow aspirate

  • Bone Marrow Biopsy

    Procedure/Surgery

    Undergo biopsy

  • Computed Tomography

    Procedure/Surgery

    Undergo CT scan

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI scan

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET/CT scan

Treatment groups

62 Participants
are divided into 2 treatment groups
Group A: Group I (low dose belantamab mafodotin)Active comparator 7 interventions
Group B: Group II (low dose and high dose belantamab mafodotin)Experimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

Grade 3/4 keratopathy-free rate

The proportion of successes will be estimated by the number of successes (proportion of patients free of grade 3/4 keratopathy at the time of dose #4) divided by the total number of evaluable patients. 95% confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. If both arms prove to meet the primary endpoint, they will be evaluated indirectly in relation to each other similar, to a Bayesian pick the winner, approach if only one can be brought forward for further testing

Time frame
At the time of dose 4

Secondary outcomes

1

Overall response rate

Will be estimated by the total number of patients who achieve a complete response (CR), very good partial response, or partial response divided by the total number of evaluable patients. All evaluable patients will be used for this analysis. Exact binomial 95% confidence intervals for the true overall response rate will be calculated.

Time frame
Up to 5 years
2

Incidence of adverse events (AEs)

The maximum grade for each type of AE will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the AEs to the study treatment will be taken into consideration.

Time frame
Up to 5 years
3

Time to progression

The distribution of time will be estimated using the method of Kaplan-Meier.

Time frame
From registration to the earliest date of documentation of disease progression, assessed up to 5 years
4

Progression free survival (PFS)

The distribution of PFS will be estimated using the method of Kaplan-Meier.

Time frame
From registration to the earliest date of documentation of disease progression or relapse or death due to any cause, assessed up to 5 years

Other outcomes

Sponsors and contacts

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

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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