Clinical trial NCT03544281: 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)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Multiple Myeloma
Keywords: Relapsed / Refractory Multiple Myeloma
Antibody-Drug Conjugate
belantamab mafodotin
Combination therapy
Belamaf
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: Iqvia Pty Ltd
First posted: 2018-06-01
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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 (\<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.

Primary outcomes:
measure: Number of Participants With Dose Limiting Toxicities (DLTs), Treatment A
timeFrame: Up to 28 days
measure: Number of Participants With DLTs, Treatment B
timeFrame: Up to 21 days
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to approximately 4.5 years
measure: 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
measure: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
timeFrame: Baseline (Day 1) and up to approximately 4.5 years
measure: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
timeFrame: Baseline (Day 1) and up to approximately 4.5 years
measure: 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
measure: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
timeFrame: Baseline (Day 1) and up to approximately 4.5 years
measure: 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
measure: Change From Baseline in Urine Potential of Hydrogen (pH)
timeFrame: Baseline (Day 1) and up to approximately 4.5 years
measure: Change From Baseline in Urine Specific Gravity
timeFrame: Baseline (Day 1) and up to approximately 4.5 years
measure: 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
measure: Change From Baseline in Vital Signs : Pulse Rate
timeFrame: Baseline (Day 1) and up to approximately 4.5 years
measure: Change From Baseline in Vital Signs : Temperature
timeFrame: Baseline (Day 1) and up to approximately 4.5 years
measure: 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:
measure: 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
measure: 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
measure: 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
measure: 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
measure: Time of Last Observed Quantifiable Concentration (Tlast) 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 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 15-21; Cycle 1 Day 29; pre-dose Cycle 2 Day 28
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: Tlast for Belantamab Mafodotin ADC, Treatment B
timeFrame: Pre-Dose Cycle 1 Day 1 to pre-dose Cycle 5 Day 1
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: Tlast 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 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 15-21; Cycle 1 Day 29; pre-dose Cycle 2 Day 28; pre-dose Cycle 3 Day 8
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: Tlast for Belantamab Mafodotin (Total Antibody), Treatment B
timeFrame: Pre-Dose Cycle 1 Day 1 to pre-dose Cycle 9 Day 1
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: Tlast for Belantamab Mafodotin (Cys-mcMMAF), Treatment A
timeFrame: Pre-Dose Cycle 1 Day 1 to pre-dose Cycle 1 Day 15
measure: 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
measure: 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
measure: 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
measure: 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
measure: Tlast for Belantamab Mafodotin (Cys-mcMMAF), Treatment B
timeFrame: Pre-Dose Cycle 1 Day 1 to pre-dose Cycle 2 Day 1
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: Tlast for Lenalidomide (25 mg), Treatment A
timeFrame: Pre-Dose, Post dose on Cycle 1 Day 1
measure: 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
measure: 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
measure: 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
measure: 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
measure: Tlast for Lenalidomide (10 mg), Treatment A
timeFrame: Pre-Dose, Post dose on Cycle 1 Day 1
measure: Cmax for Bortezomib, Treatment B
timeFrame: Pre-Dose, 0.5, 1, 2, 4 and 24 Hours Post-Dose on Cycle 1 Day 1
measure: 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
measure: 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
measure: 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
measure: Tlast for Bortezomib, Treatment B
timeFrame: Pre-Dose, Post dose on Cycle 1 Day 3
measure: Number of Participants With Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin
timeFrame: Up to approximately 4.5 years (End of Treatment [EoT])
measure: Titers of ADAs Against Belantamab Mafodotin
timeFrame: Up to approximately 4.5 years
measure: Change From Baseline in Ocular Surface Disease Index (OSDI) Total Scores
timeFrame: Baseline (Day 1) and up to approximately 4.5 years
measure: 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
measure: 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
measure: Number of Participants With AEs of Special Interest (AESI)
timeFrame: Up to approximately 4.5 years
measure: 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
measure: 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
measure: 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
measure: 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
measure: Number of Participants With Worse Grade Post-baseline Punctate Keratopathy Findings
timeFrame: Baseline (Day 1) and up to approximately 4.5 years
measure: 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])
measure: 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])
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Goodyear
country: United States
facility: GSK Investigational Site
state: Arizona
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Indianapolis
country: United States
facility: GSK Investigational Site
state: Indiana
city: Lansing
country: United States
facility: GSK Investigational Site
state: Michigan
city: Saint Louis
country: United States
facility: GSK Investigational Site
state: Missouri
city: Grand Island
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Hackensack
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Bronx
country: United States
facility: GSK Investigational Site
state: New York
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: Greer
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Wollongong
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Woodville
country: Australia
facility: GSK Investigational Site
state: South Australia
city: Fitzroy
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Melbourne
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Melbourne
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Murdoch
country: Australia
facility: GSK Investigational Site
state: Western Australia
city: Nedlands
country: Australia
facility: GSK Investigational Site
state: Western Australia
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Salamanca
country: Spain
facility: GSK Investigational Site
city: Truro
country: United Kingdom
facility: GSK Investigational Site
state: Cornwall
city: London
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: