Last updated: 02/28/2025 07:00:15

To evaluate safety, tolerability, and clinical activity of the antibody-drug conjugate, GSK2857916 administered in combination with lenalidomide plus dexamethasone (Arm A), or in combination with bortezomib plus dexamethasone (Arm B) in participants with Relapsed/Refractory Multiple Myeloma (RRMM)DREAMM 6

GSK study ID
207497
See study documents
Clinicaltrials.gov ID
NCT03544281
See results summary
EudraCT ID
2017-004689-93
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Phase I/II, Open-label, Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-Drug Conjugate GSK2857916 Administered in Combination with Lenalidomide Plus Dexamethasone (Arm A), or Bortezomib Plus Dexamethasone (Arm B) in Participants with Relapsed / Refractory Multiple Myeloma – DREAMM-6
Trial description: This study will evaluate the safety and tolerability profile of belantamab mafodotin when administered in combination with approved regimens of either Lenalidomide Plus Dexamethasone [Len/Dex (Treatment A)] or Bortezomib Plus Dexamethasone [Bor/Dex (Treatment B)] in participants with RRMM, i.e., those who have relapsed or who are refractory to at least 1 line of approved therapy.
Participants receiving treatment A, may continue combination treatment until the occurrence of progressive disease (PD), intolerable adverse events (AEs ), consent withdrawal, death or end of study. The participants receiving treatment B, may continue combination treatment for a total of up to 8 cycles. After 8 cycles of combination therapy, the participants will continue treatment with belantamab mafodotin, as a monotherapy until the occurrence of PD, intolerable AEs, consent withdrawal, death or end of study.
Primary purpose:
Treatment
Trial design:
Sequential Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Number of participants with dose limiting toxicities (DLTs), Treatment A

Timeframe: Up to 28 days

Number of participants with DLTs, Treatment B

Timeframe: Up to 21 days

Number of participants with adverse events (AEs) and serious adverse events (SAEs)

Timeframe: Up to approximately 4.5 years

Number of participants with Worst-Case Amount of Increase from Baseline Value in Corrected QT Interval Using Fredericia's Formula (QTcF)

Timeframe: Up to approximately 4.5 years

Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters

Timeframe: Baseline (Day 1) and up to approximately 4.5 years

Number of Participants With Worst-case Change Post-baseline in Hematology Parameters

Timeframe: Baseline (Day 1) and up to approximately 4.5 years

Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters

Timeframe: Baseline (Day 1) and up to approximately 4.5 years

Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters

Timeframe: Baseline (Day 1) and up to approximately 4.5 years

Number of participants with Worst-case change post baseline urinalysis results: Occult Blood and Protein

Timeframe: Baseline (Day 1) and up to approximately 4.5 years

Change from baseline in urine Potential of Hydrogen (pH)

Timeframe: Baseline (Day 1) and up to approximately 4.5 years

Change from baseline in urine specific gravity

Timeframe: Baseline (Day 1) and up to approximately 4.5 years

Change from Baseline in vital Signs: Diastolic blood pressure (DBP) and Systolic blood pressure (SBP)

Timeframe: Baseline (Day 1) and up to approximately 4.5 years

Change from Baseline in vital Signs : Pulse Rate

Timeframe: Baseline (Day 1) and up to approximately 4.5 years

Change from Baseline in vital Signs : Temperature

Timeframe: Baseline (Day 1) and up to approximately 4.5 years

Overall Response Rate (ORR) as defined by the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma (MM)

Timeframe: Up to approximately 4.5 years

Secondary outcomes:

Maximum observed concentration (Cmax) for belantamab mafodotin antibody-drug conjugate (ADC), Treatment A

Timeframe: Pre-Dose, 0, 2 and 24 hours post-dose on Cycle 1 Day 1 and Cycle 1 Day 8

Area under the concentration time curve (AUC) from time 0 to 504 hours (0-504h) for belantamab mafodotin ADC, Treatment A

Timeframe: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 15-21

AUC (0-672h) for belantamab mafodotin ADC, Treatment A

Timeframe: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 15-21; Cycle 1 Day 28

Time to reach maximum observed concentration (Tmax) for belantamab mafodotin ADC, Treatment A

Timeframe: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8

Time of last observed quantifiable concentration (tlast) for belantamab mafodotin ADC, Treatment A

Timeframe: Pre-Dose Cycle 1 Day 1 to pre-dose Cycle 2 Day 28

Trough concentration prior to the next dose for each cycle (Ctrough) for belantamab mafodotin ADC, Treatment A

Timeframe: Cycle 1: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Days 1 and 8; Weeks 5, 9, and 13: Pre-Dose and Post-Dose on Days 1 and 8

Observed plasma concentration at the end of infusion (C-EOI) for belantamab mafodotin ADC, Treatment A

Timeframe: Cycle 1: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Days 1 and Day 8; Weeks 5, 9, and 13: Pre-Dose and Post-Dose on Days 1 and 8

Cmax for belantamab mafodotin ADC, Treatment B

Timeframe: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8

AUC (0-504h) for belantamab mafodotin ADC, Treatment B

Timeframe: Pre-Dose, 0, 2 and 24 Hours Post Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 21

AUC (0-1008h) for belantamab mafodotin ADC, Treatment B

Timeframe: Pre-Dose, 0, 2 and 24 Hours Post Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 11; Cycle 1 Day 22; Pre-Dose and Post-Dose on Week 5 Day 7

Tmax for belantamab mafodotin ADC, Treatment B

Timeframe: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8

tlast for belantamab mafodotin ADC, Treatment B

Timeframe: Pre-Dose Cycle 1 Day 1 to pre-dose Cycle 5 Day 1

Ctrough for belantamab mafodotin ADC, Treatment B

Timeframe: Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 4 Day 1, Week 7 Day 1, Week 10 Day 1, Week 13 Day 1, Week 13 Day 8

C-EOI for belantamab mafodotin ADC, Treatment B

Timeframe: Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 4 Day 1, Week 7 Day 1, Week 7 Day 8, Week 7 Day 11, Week 10 Day 1, Week 10 Day 8, Week 13 Day 1, Week 13 Day 8

Cmax for belantamab mafodotin (Total Antibody), Treatment A

Timeframe: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8

AUC (0-504h) for belantamab mafodotin (Total Antibody), Treatment A

Timeframe: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 15-21

AUC (0-672h) for belantamab mafodotin (Total Antibody), Treatment A

Timeframe: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 15-21; Cycle 1 Day 28

AUC (0-1008h) for belantamab mafodotin (Total Antibody), Treatment A

Timeframe: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 29; Pre-Dose and Post-Dose on Week 5 Day 7

AUC(0-1344h) for belantamab mafodotin (Total Antibody), Treatment A

Timeframe: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 29; Pre-Dose and Post-Dose on Week 7 Day 7

Tmax for belantamab mafodotin (Total Antibody), Treatment A

Timeframe: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8

tlast for belantamab mafodotin (Total Antibody), Treatment A

Timeframe: Pre-Dose Cycle 1 Day 1 to pre-dose Cycle 3 Day 8

Ctrough for belantamab mafodotin (Total Antibody), Treatment A

Timeframe: Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 5 Day 1, Week 5 Day 8, Week 9 Day 1, Week 9 Day 8, Week 13 Day 1, Week 13 Day 8

C-EOI for belantamab mafodotin (Total Antibody), Treatment A

Timeframe: Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 5 Day 1, Week 5 Day 8, Week 9 Day 1, Week 9 Day 8, Week 13 Day 1, Week 13 Day 8

Cmax for belantamab mafodotin (Total Antibody) Treatment B

Timeframe: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8

AUC (0-504h) for belantamab mafodotin (Total Antibody), Treatment B

Timeframe: Pre-Dose, 0, 2 and 24 Hours Post Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 21

AUC (0-1008h) for belantamab mafodotin (Total Antibody), Treatment B

Timeframe: Pre-Dose, 0, 2 and 24 Hours Post Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 11; Cycle 1 Day 22; Pre-Dose and Post-Dose on Week 5 Day 7

Tmax for belantamab mafodotin (Total Antibody), Treatment B

Timeframe: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8

tlast for belantamab mafodotin (Total Antibody), Treatment B

Timeframe: Pre-Dose Cycle 1 Day 1 to pre-dose Cycle 9 Day 1

Ctrough for belantamab mafodotin (Total Antibody), Treatment B

Timeframe: Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 4 Day 1, Week 7 Day 1, Week 7 Day 8, Week 10 Day 1, Week 13 Day 1, Week 13 Day 8

C-EOI for belantamab mafodotin (Total Antibody), Treatment B

Timeframe: Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 4 Day 1, Week 7 Day 1, Week 7 Day 8, Week 7 Day 11, Week 10 Day 1, Week 13 Day 1, Week 13 Day 8

Cmax for belantamab mafodotin Cysteine Maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF), Treatment A

Timeframe: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8

AUC (0-168h) for belantamab mafodotin (Cys-mcMMAF), Treatment A

Timeframe: Pre-dose, 0, 2, and 24 Hours Post Dose on Cycle 1 Day 1, and Cycle 1 Day 8

AUC (0-336h) for belantamab mafodotin (Cys-mcMMAF), Treatment A

Timeframe: Pre-dose, 0, 2, and 24 Hours Post Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 14

Tmax for belantamab mafodotin (Cys-mcMMAF), Treatment A

Timeframe: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8

tlast for belantamab mafodotin (Cys-mcMMAF), Treatment A

Timeframe: Pre-Dose Cycle 1 Day 1 to pre-dose Cycle 1 Day 15

C-EOI for belantamab mafodotin (Cys-mcMMAF), Treatment A

Timeframe: Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 5 Day 1, Week 7 Day 8, Week 9 Day 1, Week 9 Day 8, Week 13 Day 1, Week 13 Day 8

Cmax for belantamab mafodotin (Cys-mcMMAF) Treatment B

Timeframe: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8

AUC(0-168h) for belantamab mafodotin (Cys-mcMMAF), Treatment B

Timeframe: Pre-dose, 0, 2, and 24 Hours Post Dose on Cycle 1 Day 1, Cycle 1 Day 4; and Cycle 1 Day 7

Tmax for belantamab mafodotin (Cys-mcMMAF), Treatment B

Timeframe: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8

tlast for belantamab mafodotin (Cys-mcMMAF), Treatment B

Timeframe: Pre-Dose Cycle 1 Day 1 to pre-dose Cycle 2 Day 1

C-EOI for belantamab mafodotin (Cys-mcMMAF), Treatment B

Timeframe: Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 4 Day 1, Week 7 Day 1, Week 7 Day 8, Week 7 Day 11, Week 10 Day 1, Week 10 Day 8, Week 13 Day 1, Week 13 Day 8

Cmax for Lenalidomide (25 mg), Treatment A

Timeframe: Pre-Dose, 0.5, 1, 2, 4 and 24 hours on Cycle 1 Day 1 post lenalidomide dose

AUC(0-24h) for Lenalidomide (25 mg), Treatment A

Timeframe: Pre-Dose, 0.5, 1, 2, 4 and 24 hours on Cycle 1 Day 1 post lenalidomide dose

AUC (0-4h) for Lenalidomide (25 mg), Treatment A

Timeframe: Pre-Dose, 0.5, 1, 2 and 4 hours on Cycle 1 Day 1 post lenalidomide dose

Tmax for Lenalidomide (25 mg), Treatment A

Timeframe: Pre-Dose, 0.5, 1, 2, 4 and 24 hours on Cycle 1 Day 1 post lenalidomide dose

tlast for Lenalidomide (25 mg), Treatment A

Timeframe: Pre-Dose, Post dose on Cycle 1 Day 1

Cmax for Lenalidomide (10 mg), Treatment A

Timeframe: Pre-Dose, 0.5, 1, 2, 4 and 24 hours on Cycle 1 Day 1 post lenalidomide dose

AUC(0-24h) for Lenalidomide (10 mg), Treatment A

Timeframe: Pre-Dose, 0.5, 1, 2, 4 and 24 hours on Cycle 1 Day 1 post lenalidomide dose

AUC (0-4h) for Lenalidomide (10 mg), Treatment A

Timeframe: Pre-Dose, 0.5, 1, 2 and 4 hours on Cycle 1 Day 1 post lenalidomide dose

Tmax for Lenalidomide (10 mg), Treatment A

Timeframe: Pre-Dose, 0.5, 1, 2, 4 and 24 hours on Cycle 1 Day 1 post lenalidomide dose

tlast for Lenalidomide (10 mg), Treatment A

Timeframe: Pre-Dose, Post dose on Cycle 1 Day 1

Cmax for Bortezomib, Treatment B

Timeframe: Pre-Dose, 0.5, 1, 2, 4 and 24 Hours Post-Dose on Cycle 1 Day 1

AUC (0-72h) for Bortezomib, Treatment B

Timeframe: Pre-dose, 5 minute, 0.25, 0.5, 1, 2, 4, 6, 10, 24, 48 and 72 hour post bortezomib dose

AUC (0-t) for Bortezomib, Treatment B

Timeframe: Pre-dose, 5 minute, 0.25, 0.5, 1, 2, 4, 6, 10, 24, 48 and 72 hour post bortezomib dose

Tmax for Bortezomib, Treatment B

Timeframe: Pre-dose, 5 minute, 0.25, 0.5, 1, 2, 4, 6, 10, 24, 48 and 72 hour post bortezomib dose

tlast for Bortezomib, Treatment B

Timeframe: Pre-Dose, Post dose on Cycle 1 Day 3

Number of participants with anti-drug antibodies (ADAs) against belantamab mafodotin

Timeframe: Up to approximately 4.5 years (End of Treatment [EoT])

Titers of ADAs Against Belantamab Mafodotin

Timeframe: Up to approximately 4.5 years

Change from Baseline in Ocular Surface Disease Index (OSDI) Total Scores

Timeframe: Baseline (Day 1) and up to approximately 4.5 years

Change from Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) Overall Composite Scores

Timeframe: Baseline (Day 1) and up to approximately 4.5 years

Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Timeframe: Up to approximately 4.5 years

Number of participants with AEs of special interest (AESI)

Timeframe: Up to approximately 4.5 years

Number of Participants With Worst-case Change From Baseline in Best Corrected Visual Acuity Test (BCVA) Scores

Timeframe: Baseline (Day 1) and up to approximately 4.5 years

Number of Participants With Worst-case post-baseline Change in BCVA Scores by Snellen results

Timeframe: Baseline (Day 1) and up to approximately 4.5 years

Number of Participants With Post-baseline Decline in BCVA to Light Perception or no Light Perception

Timeframe: Baseline (Day 1) and up to approximately 4.5 years

Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline)

Timeframe: Baseline (Day 1) and up to approximately 4.5 years

Number of Participants With Worse Grade Post-baseline Punctate Keratopathy Findings

Timeframe: Baseline (Day 1) and up to approximately 4.5 years

Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score

Timeframe: Baseline (Day 1) and up to approximately 4.5 years (End of treatment [EoT])

Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score

Timeframe: Baseline (Day 1) and up to approximately 4.5 years (End of treatment [EoT])

Interventions:
  • Drug: Belantamab mafodotin
  • Drug: Lenalidomide
  • Drug: Dexamethasone
  • Drug: Bortezomib
    • Enrollment:
    153
    Primary completion date:
    2023-28-02
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Multiple Myeloma
    Product
    lenalidomide
    Collaborators
    IQVIA
    Study date(s)
    September 2018 to February 2024
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Capable of giving signed informed consent.
    • Male or female, 18 years or older (at the time consent is obtained).
    • Systemic anti-myeloma therapy (including systemic steroids) within <=14 days, or plasmapheresis within 7 days prior to the first dose of study drug.
    • Use of an investigational drug within 14 days or five half-lives (whichever is longer) preceding the first dose of study drug.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Capable of giving signed informed consent.
    • Male or female, 18 years or older (at the time consent is obtained).
    • Have confirmed diagnosis of Multiple Myeloma (MM) as defined by the IMWG.
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 for Arm A and 0 to 2 for Arm B.
    • Have undergone stem cell transplant (SCT), or are considered transplant ineligible.
    • Have been previously treated with at least 1 prior line of MM therapy, and must have documented disease progression during or after their most recent therapy.
    • Must have at least ONE aspect of measurable disease, defined as one the following: Urine M-protein excretion >=200 milligram (mg)/24 hours, or; Serum M-protein concentration >=0.5 gram (g)/deciliter (dL) (>=5.0 g/Liter), or; Serum free light chain (FLC) assay: involved FLC level >=10 mg/dL (>=100 mg/L) and an abnormal serum FLC ratio (<0.26 or >1.65).
    • Participants with a history of autologous SCT, are eligible for study participation provided the following eligibility criteria are met: Autologous SCT was >100 days prior to study enrollment; No active bacterial, viral, or fungal infection(s) present; Participant meets the remainder of the eligibility criteria.
    • All prior treatment-related toxicities (defined by National Cancer Institute Common Toxicity Criteria for Adverse Events [NCI-CTCAE], Version 4.03, 2010) must be Grade <= 1 at the time of enrollment, except for alopecia. Participants with Grade 2 neuropathy can be enrolled into Len/Dex treatment arm, but not into Bor/Dex treatment arm.
    • Adequate organ system functions as defined by the laboratory assessments.
    • The contraceptions used by female participants be consistent with local regulations, regarding methods of contraception for those participating in clinical studies. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of child bearing potential (WOCBP) or Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), preferably with low user dependency, during the intervention period and for at least 4 months after the last dose of belantamab mafodotin and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. WOCBP Participants Assigned to Arm A:
    • Due to lenalidomide being a thalidomide analogue with risk for embryo-fetal toxicity and prescribed under a pregnancy prevention/controlled distribution program, WOCBP participants will be eligible if they commit either to abstain continuously from heterosexual sexual intercourse or to use two methods of reliable birth control (one method that is highly effective; beginning 4 weeks prior to initiating treatment with lenalidomide, during therapy, during dose interruptions and continuing for 4 weeks following discontinuation of lenalidomide treatment. Thereafter, WOCBP participants must use a contraceptive method that is highly effective (with a failure rate of <1% per year) for a further 3 months, and agree not to donate eggs (ova, oocytes) for the purpose of reproduction during this period: Two negative pregnancy tests must be obtained prior to initiating lenalidomide therapy. The first test should be performed within 10-14 days and the second test within 24 hours prior to prescribing lenalidomide therapy. WOCBP Participants Assigned to Arm B
    • WOCBP assigned to Arm B must have a negative highly sensitive serum pregnancy test within 72 hours of dosing on C1D1 and agree to use effective contraception during the study and for 4 months after the last dose of belantamab mafodotin or 7 months from the last dose of bortezomib, whichever is longer.
    • Male participants using contraception should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
    • Male participants are eligible to participate if they agree to the following: Arm A: from the time of first dose of study until 6 months after the last dose of belantamab mafodotin 4 weeks after the last dose of lenalidomide, whichever is longer, to allow for clearance of any altered sperm. Arm B: from the time of first dose of study until 6 months after the last dose of belantamab mafodotin or 4 months from the last dose of bortezomib (whichever is the longer) to allow for clearance of any altered sperm.
    • Male participants must agree to refrain from donating sperm and either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR Must agree to use contraception/barrier as detailed below.
    • Agree to use a male condom even if they have undergone a successful vasectomy and female partner to use an additional highly effective contraceptive method with a failure rate of <1% per year when having sexual intercourse. Male participants should also use a condom with pregnant females. If the female partner of the male participant is pregnant at the time of enrollment, or becomes pregnant during the trial, the male participant must agree to remain abstinent (if it is consistent with their preferred and usual lifestyle) or use a male condom.
    Exclusion criteria:
    • Systemic anti-myeloma therapy (including systemic steroids) within <=14 days, or plasmapheresis within 7 days prior to the first dose of study drug.
    • Use of an investigational drug within 14 days or five half-lives (whichever is longer) preceding the first dose of study drug.
    • Prior treatment with a monoclonal antibody within 30 days of receiving the first dose of study drugs.
    • Prior allogenic stem cell transplant. Note: Participants who have undergone syngeneic transplant will be allowed only if they have no history and no currently active, graft versus host disease (GvHD).
    • Evidence of active mucosal or internal bleeding.
    • Any major surgery within the last four weeks.
    • Presence of active renal condition (infection, requirement for dialysis or any other condition that could affect participant's safety). Participants with isolated proteinuria resulting from MM are eligible, provided they fulfill criteria.
    • Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including lab abnormalities) that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures.
    • Current active liver or biliary disease (with the exception of Gilbert’s syndrome or asymptomatic gallstones, or otherwise stable chronic liver disease per investigator’s assessment).
    • Participants with invasive malignancies other than multiple myeloma are excluded, unless the second malignancy has been considered medically stable for at least 2 years. The participant must not be receiving active therapy, other than hormonal therapy for this disease. Note: Participants with curatively treated non-melanoma skin cancer are allowed without a 2-year restriction.
    • Evidence of cardiovascular risk including any of the following: Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant ECG abnormalities including 2nd degree (Type II) or 3rd degree atrioventricular (AV) block; History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within 3 months of Screening; Class III or IV heart failure as defined by the New York Heart Association functional classification system; Uncontrolled hypertension.
    • Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to drugs chemically related to belantamab mafodotin, or any of the components of the study treatment.
    • Pregnant or lactating female.
    • Active infection requiring treatment.
    • Known Human immunodeficiency virus (HIV) infection.
    • Presence of hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb at Screening or within 3 months prior to first dose of study treatment).
    • Current corneal disease except for mild punctuate keratopathy.
    • Positive hepatitis C antibody test result or positive hepatitis C Ribonucleic acid (RNA) test result at Screening or within 3 months prior to first dose of study treatment.
    • Current corneal disease except for mild punctute keratopathy.
    • Participants Assigned to Treatment A (belantamab mafodotin plus Len/Dex): Participants unable to tolerate antithrombotic prophylaxis must be excluded; Discontinuation of prior treatment with lenalidomide due to intolerable AEs.
    • Participants Assigned to Treatment B (belantamab mafodotin plus Bor/Dex): Unacceptable AEs from previous bortezomib treatment; Ongoing Grade 2 or higher peripheral neuropathy or neuropathic pain from previous bortezomib treatment; Intolerance or contraindications to anti-viral prophylaxis.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Birmingham, AL, United States, 35294
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Fitzroy, VIC, Australia, 3065
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Indianapolis, IN, United States, 46202
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Melbourne, VIC, Australia, 3000
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Nedlands, WA, Australia, 6009
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    St Louis, MO, United States, 63110
    Status
    Study Complete
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    Showing 1 - 6 of 26 Results

    Study documents

    Study report synopsis
    Available language(s): English
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    Protocol
    Available language(s): English
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    Statistical analysis plan
    Available language(s): English
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    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2023-28-02
    Actual study completion date
    2024-28-02

    Plain language summaries

    Summary of results in plain language
    Available language(s): French (Canadian), French, Spanish, English
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    To view plain language summaries on trialsummaries.com click here.

    Additional information about the trial

    Additional information
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