Mode
Text Size
Log in / Sign up
Phase 2 N=153 Treatment

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)

Multiple Myeloma

Enrolled (actual)
153
Serious AEs
52.5%
Results posted
May 2024
Primary outcome: Primary: Number of Participants With Dose Limiting Toxicities (DLTs), Treatment A — 0; 0; 0 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Belantamab mafodotin (Drug); Lenalidomide (Drug); Dexamethasone (Drug); Bortezomib (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
GlaxoSmithKline
Primary completion
Feb 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Dose Limiting Toxicities (DLTs), Treatment A
0; 0; 0
PRIMARY
Number of Participants With DLTs, Treatment B
0; 0
PRIMARY
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
12; 4; 13; 16; 12; 12
PRIMARY
Number of Participants With Worst-Case Amount of Increase From Baseline Value in Corrected QT Interval Using Fredericia's Formula (QTcF)
3; 3; 5; 3; 1; 3
PRIMARY
Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
0; 0; 0; 0; 0; 0
PRIMARY
Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
0; 0; 0; 0; 1; 1
PRIMARY
Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
3; 1; 9; 11; 8; 9
PRIMARY
Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
0; 0; 0; 0; 0; 0
PRIMARY
Number of Participants With Worst-case Change Post Baseline Urinalysis Results: Occult Blood and Protein
5; 2; 6; 6; 6; 8
PRIMARY
Change From Baseline in Urine Potential of Hydrogen (pH)
5.9; 5.8; 6.0; 5.8; 6.1; 5.8
PRIMARY
Change From Baseline in Urine Specific Gravity
1.0217; 1.0253; 1.0169; 1.0175; 1.0217; 1.0175
PRIMARY
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
72.3; 86.0; 79.5; 71.4; 73.6; 75.1
PRIMARY
Change From Baseline in Vital Signs : Pulse Rate
72.8; 73.8; 76.0; 72.8; 73.7; 76.2
PRIMARY
Change From Baseline in Vital Signs : Temperature
36.61; 36.70; 36.46; 36.43; 36.46; 36.44
PRIMARY
Overall Response Rate (ORR) as Defined by the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma (MM)
58; 75; 69; 69; 50; 83
SECONDARY
Maximum Observed Concentration (Cmax) for Belantamab Mafodotin Antibody-drug Conjugate (ADC), Treatment A
43.58; 36.41; 25.22; 39.99; 27.60
SECONDARY
Area Under the Concentration Time Curve (AUC) From Time 0 to 504 Hours (0-504h) for Belantamab Mafodotin ADC, Treatment A
3848.41; 4802.83; 4365.82; 4127.66
SECONDARY
AUC (0-672h) for Belantamab Mafodotin ADC, Treatment A
4093.12; 5114.28; 4699.00; 4432.11
SECONDARY
Time to Reach Maximum Observed Concentration (Tmax) for Belantamab Mafodotin ADC, Treatment A
2.050; 1.342; 1.100; 2.000; 1.108
SECONDARY
Time of Last Observed Quantifiable Concentration (Tlast) for Belantamab Mafodotin ADC, Treatment A
181.467; 685.608; 674.833; 671.717
SECONDARY
Trough Concentration Prior to the Next Dose for Each Cycle (Ctrough) for Belantamab Mafodotin ADC, Treatment A
1.79; 3.52; 1.08; 1.30; NA; 5.05
SECONDARY
Observed Plasma Concentration at the End of Infusion (C-EOI) for Belantamab Mafodotin ADC, Treatment A
39.10; 36.05; 25.05; 41.80; 26.55; 35.45
SECONDARY
Cmax for Belantamab Mafodotin ADC, Treatment B
52.24; 49.50; 61.16; 51.29; 21.34; 46.95
SECONDARY
AUC (0-504h) for Belantamab Mafodotin ADC, Treatment B
6129.71; 4451.74; 6073.99; 5395.98; 4341.73; 5013.84
SECONDARY
AUC (0-1008h) for Belantamab Mafodotin ADC, Treatment B
7084.63; 7396.49; 6487.41
SECONDARY
Tmax for Belantamab Mafodotin ADC, Treatment B
1.900; 1.125; 2.025; 1.175; 1.233; 1.308
SECONDARY
Tlast for Belantamab Mafodotin ADC, Treatment B
540.250; 505.592; 1009.933; 755.442; 504.567; 506.817
SECONDARY
Ctrough for Belantamab Mafodotin ADC, Treatment B
1.12; 1.92; 0.63; 0.84; 3.50; 2.12
SECONDARY
C-EOI for Belantamab Mafodotin ADC, Treatment B
44.75; 44.05; 52.00; 45.25; 22.30; 45.80
SECONDARY
Cmax for Belantamab Mafodotin (Total Antibody), Treatment A
43.09; 40.18; 26.64; 46.95; 35.11
SECONDARY
AUC (0-504h) for Belantamab Mafodotin (Total Antibody), Treatment A
6648.19; 6607.45; 6909.91; 7277.25
SECONDARY
AUC (0-672h) for Belantamab Mafodotin (Total Antibody), Treatment A
7408.65; 7249.58; 7828.12; 8146.00
SECONDARY
AUC (0-1008h) for Belantamab Mafodotin (Total Antibody), Treatment A
8143.85
SECONDARY
AUC(0-1344h) for Belantamab Mafodotin (Total Antibody), Treatment A
8633.05
SECONDARY
Tmax for Belantamab Mafodotin (Total Antibody), Treatment A
1.267; 1.342; 1.033; 2.000; 1.583
SECONDARY
Tlast for Belantamab Mafodotin (Total Antibody), Treatment A
657.267; 685.875; 674.833; 673.625
SECONDARY
Ctrough for Belantamab Mafodotin (Total Antibody), Treatment A
0.81; 3.39; 7.74; 3.16; 3.99; 2.76
SECONDARY
C-EOI for Belantamab Mafodotin (Total Antibody), Treatment A
42.70; 36.90; 27.25; 47.00; 35.00; 42.15
SECONDARY
Cmax for Belantamab Mafodotin (Total Antibody) Treatment B
41.28; 37.47; 53.29; 53.85; 22.92; 50.32
SECONDARY
AUC (0-504h) for Belantamab Mafodotin (Total Antibody), Treatment B
7310.17; 6094.55; 8386.87; 9891.43; 8283.76; 8207.69
SECONDARY
AUC (0-1008h) for Belantamab Mafodotin (Total Antibody), Treatment B
11656.56; 11328.37; 11178.97
SECONDARY
Tmax for Belantamab Mafodotin (Total Antibody), Treatment B
1.900; 2.033; 0.983; 1.142; 2.000; 1.983
SECONDARY
Tlast for Belantamab Mafodotin (Total Antibody), Treatment B
585.958; 504.983; 1414.500; 1031.467; 504.583; 505.483
SECONDARY
Ctrough for Belantamab Mafodotin (Total Antibody), Treatment B
3.13; 5.27; 1.53; 1.32; 5.88; 7.22
SECONDARY
C-EOI for Belantamab Mafodotin (Total Antibody), Treatment B
36.60; 36.75; 52.55; 51.65; 23.90; 44.35
SECONDARY
Cmax for Belantamab Mafodotin Cysteine Maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF), Treatment A
1.11; 0.55; 0.53; 1.18; 0.63
SECONDARY
AUC (0-168h) for Belantamab Mafodotin (Cys-mcMMAF), Treatment A
106.21; NA; 43.15; 113.58; 51.31
SECONDARY
AUC (0-336h) for Belantamab Mafodotin (Cys-mcMMAF), Treatment A
93.84
SECONDARY
Tmax for Belantamab Mafodotin (Cys-mcMMAF), Treatment A
24.217; 24.900; 23.667; 24.367; 23.425
SECONDARY
Tlast for Belantamab Mafodotin (Cys-mcMMAF), Treatment A
165.567; 120.283; 336.900; 166.167
SECONDARY
C-EOI for Belantamab Mafodotin (Cys-mcMMAF), Treatment A
0.43; 0.187; 0.19; 0.29; 0.29; 0.16
SECONDARY
Cmax for Belantamab Mafodotin (Cys-mcMMAF) Treatment B
0.73; 0.75; 1.03; 1.29; 0.65; 1.15
SECONDARY
AUC(0-168h) for Belantamab Mafodotin (Cys-mcMMAF), Treatment B
89.05; 52.82; 81.17
SECONDARY
Tmax for Belantamab Mafodotin (Cys-mcMMAF), Treatment B
22.225; 24.475; 23.092; 22.442; 24.083; 24.083
SECONDARY
Tlast for Belantamab Mafodotin (Cys-mcMMAF), Treatment B
85.542; 239.800; 237.992; 93.942; 241.283; 237.425
SECONDARY
C-EOI for Belantamab Mafodotin (Cys-mcMMAF), Treatment B
0.29; 0.21; 0.28; 0.32; 0.19; 0.29
SECONDARY
Cmax for Lenalidomide (25 mg), Treatment A
382.16; 331.53; 283.08
SECONDARY
AUC(0-24h) for Lenalidomide (25 mg), Treatment A
2247.36; 1577.62; 2117.26
SECONDARY
AUC (0-4h) for Lenalidomide (25 mg), Treatment A
812.22; 870.92; 620.10
SECONDARY
Tmax for Lenalidomide (25 mg), Treatment A
0.967; 1.417; 3.767
SECONDARY
Tlast for Lenalidomide (25 mg), Treatment A
20.750; 4.000; 22.050
SECONDARY
Cmax for Lenalidomide (10 mg), Treatment A
193.06; NA
SECONDARY
AUC(0-24h) for Lenalidomide (10 mg), Treatment A
1660.82; NA
SECONDARY
AUC (0-4h) for Lenalidomide (10 mg), Treatment A
486.46; NA
SECONDARY
Tmax for Lenalidomide (10 mg), Treatment A
2.000; NA
SECONDARY
Tlast for Lenalidomide (10 mg), Treatment A
21.583; NA
SECONDARY
Cmax for Bortezomib, Treatment B
NA; NA; 14.45; 14.89; 15.88
SECONDARY
AUC (0-72h) for Bortezomib, Treatment B
NA; NA; 95.10; 73.03; 73.06
SECONDARY
AUC (0-t) for Bortezomib, Treatment B
NA; NA; 89.48; 69.51; 71.70
SECONDARY
Tmax for Bortezomib, Treatment B
NA; NA; 0.533; 0.517; 0.500
SECONDARY
Tlast for Bortezomib, Treatment B
NA; NA; 68.867; NA; 68.392; 48.000
SECONDARY
Number of Participants With Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin
0; 0; 0; 1; 0; 0
SECONDARY
Titers of ADAs Against Belantamab Mafodotin
100; 100; 100
SECONDARY
Change From Baseline in Ocular Surface Disease Index (OSDI) Total Scores
11.1; 0.8; 7.8; 11.4; 10.8; 2.4
SECONDARY
Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) Overall Composite Scores
85.1; 89.0; 91.9; 91.0; 88.0; 95.5
SECONDARY
Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
8; 4; 13; 13; 8; 12
SECONDARY
Number of Participants With AEs of Special Interest (AESI)
9; 3; 12; 11; 9; 12
SECONDARY
Number of Participants With Worst-case Change From Baseline in Best Corrected Visual Acuity Test (BCVA) Scores
2; 2; 5; 3; 4; 3
SECONDARY
Number of Participants With Worst-case Post-baseline Change in BCVA Scores by Snellen Results
0; 0; 1; 0; 0; 0
SECONDARY
Number of Participants With Post-baseline Decline in BCVA to Light Perception or no Light Perception
0; 0; 0; 0; 0; 0
SECONDARY
Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline)
0; 0; 0; 2; 0; 0
SECONDARY
Number of Participants With Worse Grade Post-baseline Punctate Keratopathy Findings
2; 0; 2; 0; 0; 1
SECONDARY
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
65.8; 69.4; 58.3; 60.4; 56.2; 67.6
SECONDARY
Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score
45.0; 24.1; 26.6; 24.7; 40.7; 21.0

Summary

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.

Eligibility 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 ( 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 c
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03544281). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search