Clinical trial NCT03525678: A Study to Investigate the Efficacy and Safety of Two Doses of GSK2857916 in Participants With Multiple Myeloma Who Have Failed Prior Treatment With an Anti-CD38 Antibody
Official title: A Phase II, Open Label, Randomized, Two-Arm Study to Investigate the Efficacy and Safety of Two Doses of the Antibody Drug Conjugate GSK2857916 in Participants With Multiple Myeloma Who Had 3 or More Prior Lines of Treatment, Are Refractory to a Proteasome Inhibitor and an Immunomodulatory Agent and Have Failed an Anti-CD38 Antibody (DREAMM 2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Keywords: Relapsed Refractory multiple myeloma
Antibody-drug conjugate
Patient-Reported Outcome Version of the Common Term Criteria for Adverse Events
Quality of Life Questionnaire 20-item Multiple Myeloma module
Multiple Myeloma
Quality of Life Questionnaire 30-item Core module
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2018-05-16
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Multiple myeloma (MM) is an incurable malignancy and accounts for 1 percentage (%) of all cancers and for 10% of all hematologic malignancies. Participants with relapsed/refractory multiple myeloma (RRMM) will be included in this study, to evaluate the efficacy and safety of belantamab mafodotin (GSK2857916) monotherapy. Participants will be treated with belantamab mafodotin monotherapy until disease progression (PD) or unacceptable toxicity and will be followed for Progression Free Survival and Overall survival. The participants will be randomized to receive either frozen belantamab mafodotin at the dose of 2.5 milligram per kilogram (mg/kg) or 3.4 mg/kg administered Intravenously (IV). There will be an independent cohort of participants who will receive a lyophilized configuration of belantamab mafodotin. For participants who discontinued from the study other than Progressive disease (PD), disease evaluation will continue to be performed at 3-week intervals until confirmed PD, death, start of a new anticancer treatment, withdrawal of consent, or end of the study whichever occurs first.


Eligibility criteria: Inclusion Criteria:

* Participants who provided signed written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
* Male or female, 18 years or older.
* Participants with Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
* Participants with histologically or cytologically confirmed diagnosis of MM as defined in IMWG, 2014 criteria, and participant has undergone stem cell transplant or is considered transplant ineligible and has failed at least 3 prior lines of anti-myeloma treatments, including an anti-CD38 antibody (example \[e.g.\], daratumumab) alone or in combination, and is refractory to an Immunomodulatory drug (IMiD) (that is \[i.e.\], lenalidomide or pomalidomide), and to a proteasome inhibitor (e.g., bortezomib, ixazomib or carfilzomib).
* The participant has measurable disease with at least one of the following: Serum M-protein \>=0.5 grams per deciliter (g/dL) (\>=5 grams per Liter \[g/L\]); Urine M-protein \>=200 milligram per 24 hours (mg/24h); Serum Free light chain (FLC) assay: Involved FLC level \>=10 mg/dL (\>=100 mg/Liter) and an abnormal serum FLC ratio (\<0.26 or \>1.65).
* Participants with a history of autologous stem cell transplant are eligible for study participation provided the following eligibility criteria are met: transplant was \>100 days prior to study enrollment; no active infection(s); participants meet the remainder of the eligibility criteria outlined in the protocol.
* Participants with adequate organ system functions as defined follows: Absolute neutrophil count (ANC) \>=1.0 X 10\^9/L; Hemoglobin \>=8.0 g/dL; Platelets\>= 50 X 10\^9/L; Total bilirubin \<=1.5X Upper limit of normal (ULN). Isolated bilirubin \>=1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35 percent); Alanine aminotransferase (ALT) \<=2.5X ULN; Estimated glomerular filtration rate (eGFR) \>=30 milliliter per minute per 1.73 meter square (mL/min/m\^2); Spot urine (albumin/creatinine ratios \[spot urine\]) \<500 milligram per gram (mg/g) (56 mg per millimoles \[mg/mmol\]); Left ventricular ejection fraction (LVEF) (Echocardiogram)\>=45 percent.
* Female participants: Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. A female participant is eligible to participate if she is not pregnant or breastfeeding, and not a woman of childbearing 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 80 days after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. A WOCBP must have a negative highly sensitive serum pregnancy test (as required by local regulations) within 72 hours before the first dose of study intervention. 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.
* Male participants: Contraceptive use by men or women 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 during the intervention period and for at least 140 days: Refrain from donating sperm; 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 Agree to use a male condom and female partner to use an additional highly effective contraceptive method with a failure rate of \<1% per year as when having sexual intercourse with a WOCBP who is not currently pregnant.
* All prior treatment-related toxicities (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events \[NCI-CTCAE\]), version 4.03, must be \<=Grade 1 at the time of enrollment except for alopecia and Grade 2 peripheral neuropathy.
* For France only: A participant will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.

Exclusion Criteria:

* Systemic anti-myeloma therapy within \<=14 days, or 5 half-lives, whichever is shorter, or plasmapheresis within 7 days prior to the first dose of study drug.
* Systemic treatment with high dose steroids (equivalent to \>=60 mg prednisone daily for \>=4 days) within the past 14 days if administered to treat MM or non-MM disease.
* Symptomatic amyloidosis, active 'polyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin changes' (POEMS) syndrome, active plasma cell leukemia at the time of screening.
* Prior allogeneic stem cell transplant.
* Current corneal epithelial disease except mild punctate keratopathy.
* Use of an investigational drug within 14 days or five half-lives, whichever is shorter, 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 B-cell maturation antigen (BCMA) targeted therapy.
* 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.
* 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 unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.
* Malignancies other than disease under study are excluded, except for any other malignancy from which the participant has been disease-free for more than 2 years and, in the opinion of the principal investigators and GlaxoSmithKline Medical Monitor, will not affect the evaluation of the effects of this clinical trial treatment on the currently targeted malignancy (MM). Participants with curatively treated non-melanoma skin cancer may be enrolled.
* Evidence of cardiovascular risk including any of the following: Corrected QT interval Fridericia (QTcF) interval \>480 milliseconds (msec); Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant electrocardiogram abnormalities such as 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 six months of Screening; Class III or IV heart failure as defined by the New York Heart Association functional classification system (NYHA); Uncontrolled hypertension.
* Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to belantamab mafodotin, or any of the components of the study treatment.
* Pregnant or lactating female.
* Active infection requiring antibiotic, antiviral, or antifungal 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.
* 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.

Primary outcomes:
measure: Overall Response Rate (ORR) by Independent Review Committee (IRC) (Full Analysis Population)
timeFrame: Up to 48 weeks
measure: Overall Response Rate by Independent Review Committee (Efficacy Population)
timeFrame: Up to 48 weeks
Secondary outcomes:
measure: Overall Response Rate by Investigator Assessment (IA) (Full Analysis Population)
timeFrame: Up to 186 weeks
measure: Overall Response Rate by Investigator Assessment (Efficacy Population)
timeFrame: Up to 186 weeks
measure: Clinical Benefit Rate (CBR) by Investigator Assessment (Full Analysis Population)
timeFrame: Up to 186 weeks
measure: Clinical Benefit Rate by Investigator Assessment (Efficacy Population)
timeFrame: Up to 186 weeks
measure: Clinical Benefit Rate by Independent Review Committee (Full Analysis Population)
timeFrame: Up to 186 weeks
measure: Clinical Benefit Rate by Independent Review Committee (Efficacy Population)
timeFrame: Up to 186 weeks
measure: Duration of Response (DoR) by Investigator Assessment (Full Analysis Population)
timeFrame: Up to 186 weeks
measure: Duration of Response by Investigator Assessment (Efficacy Population)
timeFrame: Up to 186 weeks
measure: Duration of Response by Independent Review Committee (Full Analysis Population)
timeFrame: Up to 186 weeks
measure: Duration of Response by Independent Review Committee (Efficacy Population)
timeFrame: Up to 186 weeks
measure: Time to Response by Investigator Assessment (Full Analysis Population)
timeFrame: Up to 186 weeks
measure: Time to Response by Investigator Assessment (Efficacy Population)
timeFrame: Up to 186 weeks
measure: Time to Response by Independent Review Committee (Full Analysis Population)
timeFrame: Up to 186 weeks
measure: Time to Response by Independent Review Committee (Efficacy Population)
timeFrame: Up to 186 weeks
measure: Progression Free Survival by Investigator Assessment
timeFrame: Up to 186 weeks
measure: Progression Free Survival by Independent Review Committee
timeFrame: Up to 186 weeks
measure: Time to Progression by Investigator Assessment
timeFrame: Up to 186 weeks
measure: Time to Progression by Independent Review Committee
timeFrame: Up to 186 weeks
measure: Overall Survival
timeFrame: Up to 186 weeks
measure: Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range
timeFrame: Baseline (Day 1) and Up to 186 weeks
measure: Number of Participants With Grade Change From Baseline in Hematology Parameters
timeFrame: Baseline (Day 1) and Up to 186 weeks
measure: Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range
timeFrame: Baseline (Day 1) and Up to 186 weeks
measure: Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters
timeFrame: Baseline (Day 1) and Up to 186 weeks
measure: Number of Participants With Abnormal Findings During Physical Examination
timeFrame: Up to 186 weeks
measure: Number of Participants With Change From Baseline in Pulse Rate
timeFrame: Baseline (Day 1) and Up to 186 weeks
measure: Number of Participants With Change From Baseline in Body Temperature
timeFrame: Baseline (Day 1) and Up to 186 weeks
measure: Number of Participants With Grade Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
timeFrame: Baseline (Day 1) and Up to 186 weeks
measure: Number of Participants With Serious Adverse Events (SAEs), Common (>=5%) Non-serious Adverse Events and Adverse Events of Special Interest (AESI)
timeFrame: Up to 186 weeks
measure: Number of Participants With Change From Baseline in Best Corrected Visual Acuity (BCVA) Test Scores
timeFrame: Baseline (Day 1) and Up to 186 weeks
measure: Number of Participants With Intraocular Pressure (IOP) >=22 mmHg Anytime Post-Baseline
timeFrame: Up to 186 weeks
measure: Number of Participants With Shift in Pupillary Examination Findings From Normal (Baseline) to Abnormal (Worst Post-Baseline)
timeFrame: Baseline and Up to 186 weeks
measure: Number of Participants With Shift in Extraocular Muscle Movement From Yes (Baseline) to no (Worst Post-Baseline)
timeFrame: Baseline and Up to 186 weeks
measure: Number of Participants With Shift in Corneal Epithelium Findings From Normal (Baseline) to Abnormal (Worst Post-Baseline) for Corneal Epithelium (CE) and Corneal Stroma (CS)
timeFrame: Baseline and Up to 186 weeks
measure: Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline)
timeFrame: Baseline and Up to 186 weeks
measure: Number of Participants With Shift in Tear Break-up Time From >10 Seconds (Baseline) to <=5 Seconds (Worst Post-Baseline)
timeFrame: Baseline and Up to 186 weeks
measure: Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC[0-infinity]) of GSK2857916 Following IV Dose in Participants With RRMM
timeFrame: Cycle 1 and Cycle 3: Pre-dose, end of infusion (EOI), 2 hours and 24 hours post start of infusion (SOI) on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
measure: Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) of GSK2857916 Following IV Dose in Participants With RRMM
timeFrame: Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
measure: Area Under the Concentration-time Curve From Zero to Time of Last Quantifiable Concentration (AUC[0-tlast]) of GSK2857916 Following IV Dose in Participants With RRMM
timeFrame: Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
measure: Maximum Observed Concentration (Cmax) of GSK2857916 Following IV Dose in Participants With RRMM
timeFrame: Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
measure: Time to Reach Maximum Observed Concentration (Tmax) of GSK2857916 Following IV Dose in Participants With RRMM
timeFrame: Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
measure: Terminal Half-life (t1/2) of GSK2857916 Following IV Dose in Participants With RRMM
timeFrame: Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
measure: AUC(0-infinity) of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM
timeFrame: Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
measure: AUC(0-tau) of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM
timeFrame: Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
measure: AUC(0-tlast) of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM
timeFrame: Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
measure: Cmax of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM
timeFrame: Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
measure: Tmax of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM
timeFrame: Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
measure: t1/2 of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM
timeFrame: Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
measure: AUC(0-infinity) of Cysteine-maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF) Following IV Dose of GSK2857916 in Participants With RRMM
timeFrame: Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
measure: AUC(0-tau) of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM
timeFrame: Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
measure: AUC(0-tlast) of Cysteine-maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF) Following IV Dose of GSK2857916 in Participants With RRMM
timeFrame: Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
measure: Cmax of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM
timeFrame: Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
measure: Tmax of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM
timeFrame: Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
measure: t1/2 of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM
timeFrame: Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
measure: Number of Participants With at Least One Confirmed Positive Post-Baseline Anti-drug Antibody (ADA) Result
timeFrame: Up to 186 weeks
measure: Titers of Anti-drug Antibodies Against GSK2857916
timeFrame: Up to 186 weeks
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 186 weeks
measure: Worst Change From Baseline in National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) Overall Composite Score
timeFrame: Baseline (Day 1) and up to Week 186
measure: Worst Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score
timeFrame: Baseline (Day 1) and up to Week 186
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 Week 07, Week 13, Week 19, Week 25, Week 31, Week 37, Week 43, Week 61, Week 79, Week 97, Week 115, Week 133, Week 151, Week 169, and Week 186
measure: Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score
timeFrame: Baseline (Day 1) and Week 07, Week 13, Week 19, Week 25, Week 31, Week 37, Week 43, Week 61, Week 79, Week 97, Week 115, Week 133, Week 151, Week 169, and Week 186
Other outcomes:
Locations:
city: New Haven
country: United States
facility: GSK Investigational Site
state: Connecticut
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: GSK Investigational Site
state: Indiana
city: Fairway
country: United States
facility: GSK Investigational Site
state: Kansas
city: Baton Rouge
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Baltimore
country: United States
facility: GSK Investigational Site
state: Maryland
city: Boston
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Rochester
country: United States
facility: GSK Investigational Site
state: Minnesota
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: Charlotte
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Columbus
country: United States
facility: GSK Investigational Site
state: Ohio
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Nashville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: GSK Investigational Site
state: Utah
city: Seattle
country: United States
facility: GSK Investigational Site
state: Washington
city: Madison
country: United States
facility: GSK Investigational Site
state: Wisconsin
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: Calgary
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Winnipeg
country: Canada
facility: GSK Investigational Site
state: Manitoba
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Lille
country: France
facility: GSK Investigational Site
city: Nantes cedex 1
country: France
facility: GSK Investigational Site
city: Paris
country: France
facility: GSK Investigational Site
city: Pessac cedex
country: France
facility: GSK Investigational Site
city: Pierre BEnite
country: France
facility: GSK Investigational Site
city: Toulouse cedex 9
country: France
facility: GSK Investigational Site
city: Dresden
country: Germany
facility: GSK Investigational Site
city: Hannover
country: Germany
facility: GSK Investigational Site
city: Koblenz
country: Germany
facility: GSK Investigational Site
city: Schwerin
country: Germany
facility: GSK Investigational Site
city: Tuebingen
country: Germany
facility: GSK Investigational Site
city: Wuerzburg
country: Germany
facility: GSK Investigational Site
city: Aviano PN
country: Italy
facility: GSK Investigational Site
city: Parma
country: Italy
facility: GSK Investigational Site
city: Rionero In Vulture PZ
country: Italy
facility: GSK Investigational Site
city: Torino
country: Italy
facility: GSK Investigational Site
city: Badalona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Granada
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Murcia
country: Spain
facility: GSK Investigational Site
city: PamplonaNavarra
country: Spain
facility: GSK Investigational Site
city: Salamanca
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Birmingham
country: United Kingdom
facility: GSK Investigational Site
city: Bournemouth
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: Nottingham
country: United Kingdom
facility: GSK Investigational Site
city: Oxford
country: United Kingdom
facility: GSK Investigational Site
city: Stoke on Trent
country: United Kingdom
facility: GSK Investigational Site
city: Sutton
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: S Lonial, HC Lee, A Badros, S Trudel, AK Nooka, A Chari, A-O Abdallah, N Callander, N Lendvai, D Sborov, A Suvannasankha, K Weisel, L Karlin, E Libby, B Arnulf, T Facon, C Hulin, KM Kortüm, P Rodríguez-Otero, SZ Usmani, P Hari, R Baz, H Quach, P Moreau, PM Voorhees, I Gupta, A Hoos, E Zhi, J Baron, T Piontek, E Lewis, RC Jewell, EJ Dettman, R Popat, S Degli Esposti, J Opalinska, P Richardson, AD Cohen. Single-agent Belantamab Mafodotin for Relapsed or Refractory Multiple Myeloma: Results of the Pivotal Phase II Randomised DREAMM-2 Study. Lancet Oncol. 2020;21(7):207-221 DOI: https://doi.org/10.1016/S1470-2045(19)30788-0 PMID: 31859245
citation: Prawitz T, Popat R, Suvannasankha A, Sarri G, Hughes R, Wang F, Hogea C, Ferrante SA, Gorsh B, Willson J, Kapetanakis V. DREAMM-2: Indirect Comparisons of Belantamab Mafodotin vs. Selinexor + Dexamethasone and Standard of Care Treatments in Relapsed/Refractory Multiple Myeloma. Adv Ther. 2021 Nov;38(11):5501-5518. doi: 10.1007/s12325-021-01884-7. Epub 2021 Sep 24.
citation: Nooka AK, Cohen AD, Lee HC, Badros A, Suvannasankha A, Callander N, Abdallah AO, Trudel S, Chari A, Libby EN, Chaudhry M, Hultcrantz M, Kortum KM, Popat R, Sborov D, Hakim S, Lewis E, Gorsh B, Bhushan B, McKeown A, Gupta I, Opalinska J, Richardson PG, Lonial S. Single-agent belantamab mafodotin in patients with relapsed/refractory multiple myeloma: Final analysis of the DREAMM-2 trial. Cancer. 2023 Dec 1;129(23):3746-3760. doi: 10.1002/cncr.34987. Epub 2023 Aug 25.
citation: Nikolaou A, Ambavane A, Shah A, Ma W, Tosh J, Kapetanakis V, Willson J, Wang F, Hogea C, Gorsh B, Gutierrez B, Sapra S, Suvannasankha A, Samyshkin Y. Belantamab mafodotin for the treatment of relapsed/refractory multiple myeloma in heavily pretreated patients: a US cost-effectiveness analysis. Expert Rev Hematol. 2021 Dec;14(12):1137-1145. doi: 10.1080/17474086.2021.1970522. Epub 2021 Sep 20.
citation: Lonial S, Lee HC, Badros A, Trudel S, Nooka AK, Chari A, Abdallah AO, Callander N, Sborov D, Suvannasankha A, Weisel K, Voorhees PM, Womersley L, Baron J, Piontek T, Lewis E, Opalinska J, Gupta I, Cohen AD. Longer term outcomes with single-agent belantamab mafodotin in patients with relapsed or refractory multiple myeloma: 13-month follow-up from the pivotal DREAMM-2 study. Cancer. 2021 Nov 15;127(22):4198-4212. doi: 10.1002/cncr.33809. Epub 2021 Jul 27.
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