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A Study to Investigate the Safety and Clinical Activity of Belantamab Mafodotin in Combination With Daratumumab, Pomalidomide and Dexamethasone in Patients With Relapsed/ Refractory Multiple Myeloma Previously Treated With One Line Therapy Who Are Lenalidomide Refractory

ConditionsMultiple MyelomaMultiple Myeloma in RelapseNeoplasmsGammopathy, MonoclonalParaproteinemiasBlood Protein DisordersHaematologic DiseaseCorneal DiseaseNeoplasms, Plasma Cell
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHellenic Society of Hematology

About this trial

This is a phase 1/2, open label, single-center study designed to assess the safety and preliminary clinical activity of different belantamab mafodotin doses in combination with daratumumab, pomalidomide, and dexamethasone (DPd) in patients with Relapsed/ Refractory Multiple Myeloma (RRMM) previously treated with one line of therapy who are lenalidomide refractory.

This will be a 2-Part study. Part 1 will evaluate the safety of belantamab mafodotin in combination with DPd in 2 cohorts and determine the Recommended Phase 2 Dose (RP2D). In the dose expansion phase (Part 2) an expansion cohort will be treated with the RP2D. The expansion cohort will randomize participants (1:1) in two groups to evaluate two alternate dose modification guidelines for corneal AEs. Part 2 will further evaluate the safety and assess the preliminary clinical activity of the belantamab mafodotin RP2D in combination with DPd.

Overall, approximately 48 participants will be enrolled in the study. Participant follow-up will continue up to 3 years after the last participant is randomized. The estimated accrual period will be 12 months corresponding to an approximate total study duration of 4 years.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant must be ≥18 years or older.

Documented diagnosis of Multiple Myeloma (MM) as per International Myeloma Working Group (IMWG) criteria.

Urine M-protein excretion ≥200 mg/24 hrs (≥0.2 g/24 hrs), or

Serum M-protein concentration ≥0.5 g/dL (≥5.0 g/L), or

Disqualifiers

Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the National Cancer Institute, Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 5.

Major surgery within 4 weeks before the first dose of study drug

NOTE 1: participant must be clinically stable following a major surgery to be entered in the study.

NOTE 2: major surgery shall be defined based on the Investigator's judgment according to the extent and complexity of the procedure, its pathophysiological consequences and consecutive clinical outcomes.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Belantamab Mafodotin-Blmf

    Drug

    Blmf will be available as 100 mg/vial in single-use vial for reconstitution, supplied as lyophilized powder. Blmf will be delivered as IV solution over at least 30 minutes

  • Daratumumab

    Drug

    Daratumumab will be administered with subcutaneous injections. On days where Blmf is given together with daratumumab, daratumumab should be performed first.

  • Pomalidomide

    Drug

    Pomalidomide will be administered per os.

  • Dexamethasone

    Drug

    Dexamethasone will be administered intravenously or per os.

Treatment groups

48 Participants
are divided into 1 treatment group
Group A: Part 1 : Dose findingExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Part 1: Dose-Limiting Toxicity (DLT)

The number (percent) of participants with DLTs using the DLT evaluable population.

Time frame
Up to 28 days
2

Part 1 and 2: Adverse Events (AEs) and Serious adverse events (SAEs)

The number (percent) of participants with AEs and SAEs using the DLT evaluable and Safety populations.

Time frame
Up to 4 years
3

Part 1 and 2: Ocular Toxicity

The number (percent) of participants with Grade ≥2 ocular toxicity per Keratopathy Visual Acuity (KVA) scale.

Time frame
Up to 4 years
4

Part 2: Overall Response Rate (ORR)

ORR as per IMWG by Investigator assessment; defined as the percentage of participants with a confirmed partial response (PR), very good partial response (VGPR), complete response (CR) or stringent CR (sCR) (For the 'intention to treat' (ITT) population).

Time frame
Up to 4 years

Secondary outcomes

1

Part 1 and 2: Cumulative dose of belantamab mafodotin

Cumulative belantamab mafodotin dose of (DLT evaluable population, safety population) administered in combination with daratumumab, pomalidomide and dexamethasone, i.e., the total dose of belantamab mafodotin that was administered.

Time frame
Up to 4 years
2

Part 1: Overall Response Rate (ORR)

ORR and 95% CI as per IMWG by Investigator Assessment (ITT population); ORR is defined as the percentage of participants with a confirmed PR, VGPR, CR or sCR.

Time frame
Up to 4 years
3

Part 1: Very good partial response (VGPR)

VGPR+ and 95% CI as per IMWG by Investigator Assessment (ITT population);ORR is defined as the percentage of participants with a confirmed VGPR, CR or sCR.

Time frame
Up to 4 years
4

Part 1 and 2: Time to response (TTR)

TTR as per IMWG by Investigator Assessment (ITT population). TTR is defined as the time (in months) between the date of randomization and the first evidence of confirmed response (PR or better) for participants who achieve a response (i.e., confirmed PR or better).

Time frame
Up to 4 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Hellenic Society of Hematology

Lead sponsor

GlaxoSmithKline

Collaborator

Source ClinicalTrials.gov

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