A Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Standard of Care in Participants With Relapsed-Refractory Multiple Myeloma (RRMM)

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGlaxoSmithKline

About this trial

This study is for adults with multiple myeloma (a type of blood cancer) that has come back after being treated earlier or isn't responding to the current treatment.

The main goal is to find out if the study drug, belantamab mafodotin, given less often (on an extended schedule) with other cancer medicines, can still treat the cancer effectively while causing fewer side effects, especially those affecting the eyes. The study will also look at how well the treatment works overall and how safe it is when administered to the participants.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female, 18 years or older (at the time consent is obtained).

Have a confirmed diagnosis of Multiple Myeloma (MM) as defined by the International Myeloma Working Group (IMWG) criteria.

Eastern Cooperative Oncology Group (ECOG) performance status of zero to 2.

Have been previously treated with at least 1, but no more than 2, prior lines of MM therapy and must have documented disease progression during or after their most recent therapy.

Disqualifiers

Active plasma cell leukemia at Screening.

Symptomatic amyloidosis, including active Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal plasma proliferative disorder, and Skin changes (POEMS).

The disease must be considered medically stable for at least 2 years; or

The patient must not be receiving active therapy, other than hormonal therapy for this disease.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Belantamab mafodotin

    Drug

    Belantamab mafodotin will be administered.

  • Dexamethasone

    Drug

    Dexamethasone will be administered.

  • Pomalidomide

    Drug

    Pomalidomide will be administered.

  • Bortezomib

    Drug

    Bortezomib will be administered.

  • Carfilzomib

    Drug

    Carfilzomib will be administered.

Treatment groups

200 Participants
are divided into 3 treatment groups
Group A: Belantamab mafodotin + Pomalidomide + Dexamethasone (BPd)Experimental treatment 3 interventions
Group B: Belantamab mafodotin + Bortezomib + Dexamethasone (BVd)Experimental treatment 3 interventions
Group C: Belantamab mafodotin + Carfilzomib + dexamethasone (BKd)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Overall Response Rate (ORR)

ORR is defined as the percentage of participants with a confirmed partial response \[PR\] or better (i.e., PR, very good partial response (VGPR), complete response \[CR\], stringent complete response \[sCR\]). Responses will be assessed using International Myeloma Working Group (IMWG) criteria.

Time frame
Up to approximately 52 months

Secondary outcomes

1

Complete Response Rate (CRR)

CRR is defined as the percentage of participants with a confirmed CR or better (i.e., CR, sCR).

Time frame
Up to approximately 52 months
2

Minimal Residual Disease (MRD) Negativity Rate

MRD negativity rate is defined as the percentage of participants who achieve MRD negative status (as assessed by Next generation sequencing \[NGS\] at 10\^-5 threshold) at least once during the time of confirmed CR or better response as per IMWG.

Time frame
Up to approximately 52 months
3

Duration of Response (DoR)

DoR is defined as the time from first documented evidence of PR or better until PD or death due to any cause.

Time frame
Up to approximately 52 months
4

Number of participants with adverse events (AEs), Serious adverse events (SAEs) by severity

Time frame
Up to approximately 52 months

Other outcomes

Sponsors and contacts

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