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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05064358




Registration number
NCT05064358
Ethics application status
Date submitted
22/09/2021
Date registered
1/10/2021

Titles & IDs
Public title
Study to Investigate Alternative Dosing Regimens of Belantamab Mafodotin in Participants With Relapsed or Refractory Multiple Myeloma
Scientific title
A Phase 2, Randomized, Parallel, Open-label Study to Investigate the Safety, Efficacy, and Pharmacokinetics of Various Dosing Regimens of Single-agent Belantamab Mafodotin (GSK2857916) in Participants With Relapsed or Refractory Multiple Myeloma (DREAMM-14)
Secondary ID [1] 0 0
2021-004151-16
Secondary ID [2] 0 0
209628
Universal Trial Number (UTN)
Trial acronym
DREAMM 14
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Belantamab mafodotin

Experimental: Cohort 1: Participants receiving belantamab mafodotin at dose level (DL) 1 -

Experimental: Cohort 2: Participants receiving belantamab mafodotin at DL 2 -

Experimental: Cohort 3: Participants receiving belantamab mafodotin at DL 3 -

Experimental: Cohort 4: Participants receiving belantamab mafodotin at DL 4 -

Experimental: Cohort 5: Participants receiving belantamab mafodotin at DL4 with alternative dose modification -


Treatment: Drugs: Belantamab mafodotin
Belantamab mafodotin will be administered.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence rate of Grade =2 Corneal events according to the keratopathy visual acuity (KVA) scale
Timepoint [1] 0 0
Up to 12 months
Secondary outcome [1] 0 0
Cumulative event rate of corneal events to Week 16 (KVA scale)
Timepoint [1] 0 0
Up to Week 16
Secondary outcome [2] 0 0
Incidence rate of corneal events by grade (KVA scale)
Timepoint [2] 0 0
Up to 12 months
Secondary outcome [3] 0 0
Exposure adjusted incidence rate of corneal events by grade (KVA scale)
Timepoint [3] 0 0
Up to 12 months
Secondary outcome [4] 0 0
Median duration of dose delay
Timepoint [4] 0 0
Up to 12 months
Secondary outcome [5] 0 0
Percentage of participants requiring dose reductions, dose delays, and study treatment discontinuation due to corneal events
Timepoint [5] 0 0
Up to 12 months
Secondary outcome [6] 0 0
Cumulative incidence of corneal events by grade
Timepoint [6] 0 0
Up to 12 months
Secondary outcome [7] 0 0
Toxicity Index score by assessment/visit
Timepoint [7] 0 0
Up to 12 months
Secondary outcome [8] 0 0
Duration of corneal events
Timepoint [8] 0 0
Up to 12 months
Secondary outcome [9] 0 0
Percentage of time on study with corneal events
Timepoint [9] 0 0
Up to 12 months
Secondary outcome [10] 0 0
Change in best corrected visual acuity (BCVA)
Timepoint [10] 0 0
Up to 12 months
Secondary outcome [11] 0 0
Overall response rate (ORR)
Timepoint [11] 0 0
Up to 12 months
Secondary outcome [12] 0 0
Percentage of participants with very good partial response (VGPR) or better
Timepoint [12] 0 0
Up to 12 months
Secondary outcome [13] 0 0
Time to response (TTR)
Timepoint [13] 0 0
Up to 12 months
Secondary outcome [14] 0 0
Duration of response (DoR)
Timepoint [14] 0 0
Up to 12 months
Secondary outcome [15] 0 0
Time to progression (TTP)
Timepoint [15] 0 0
Up to 12 months
Secondary outcome [16] 0 0
Progression-free survival (PFS)
Timepoint [16] 0 0
Up to 12 months
Secondary outcome [17] 0 0
Overall survival (OS)
Timepoint [17] 0 0
Up to 12 months
Secondary outcome [18] 0 0
Number of participants with AEs and serious AEs (SAEs)
Timepoint [18] 0 0
Up to 12 months
Secondary outcome [19] 0 0
Number of participants with clinically significant changes in hematology, clinical chemistry and urinalysis laboratory parameters
Timepoint [19] 0 0
Up to 12 months
Secondary outcome [20] 0 0
Percentage of participants requiring dose reductions, dose delays, and study treatment discontinuation due to any AEs
Timepoint [20] 0 0
Up to 12 months
Secondary outcome [21] 0 0
Maximum concentration (Cmax) of belantamab mafodotin
Timepoint [21] 0 0
Up to 12 months
Secondary outcome [22] 0 0
Time taken to reach Cmax (Tmax) of belantamab mafodotin
Timepoint [22] 0 0
Up to 12 months
Secondary outcome [23] 0 0
Area under the concentration time-curve (AUC) of belantamab mafodotin
Timepoint [23] 0 0
Up to 12 months
Secondary outcome [24] 0 0
Number of participants with positive anti-drug antibodies (ADAs) against belantamab mafodotin
Timepoint [24] 0 0
Up to 12 months
Secondary outcome [25] 0 0
Titers of ADAs against belantamab mafodotin
Timepoint [25] 0 0
Up to 12 months

Eligibility
Key inclusion criteria
* Participant must be 18 years of age inclusive at the time of signing the informed consent form (ICF).
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
* Histologically or cytologically confirmed diagnosis of MM and a. Has undergone stem cell transplant or is considered transplant ineligible, and b. Has failed at least 3 prior lines of anti-myeloma therapies, including an anti-cluster of differentiation (CD)38 antibody (e.g., daratumumab) alone or in combination and is refractory to an immunomodulatory agent (e.g., lenalidomide, pomalidomide) and a proteasome inhibitor (e.g., bortezomib, ixazomib, carfilzomib).
* France specific: participants have failed at least 4 prior lines of anti-myeloma therapies
* Participant has measurable disease per modified IMWG criteria.
* Life expectancy of at least 6 months, in the opinion of the investigator.
* Male and female participants agree to abide by protocol-defined contraceptive requirements.
* Participant is capable of giving signed informed consent.
* Participant meets country-specific inclusion criteria described in the protocol.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Symptomatic amyloidosis, active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin changes), or active plasma cell leukemia at the time of screening.
* Current corneal epithelial disease, except nonconfluent superficial punctate keratitis (SPK).
* Evidence of active mucosal or internal bleeding.
* Presence of an active renal condition.
* Any serious and/or unstable pre-existing medical condition, psychiatric disorder, or other conditions that could interfere with the participant's safety, obtaining informed consent, or compliance with the study procedures.
* Malignancies other than the disease under study, except for any other malignancy from which the participant has been disease free for >2 years and, will not affect the evaluation of the effects of the study treatment on the currently targeted malignancy (MM). Participants with curatively treated non-melanoma skin cancer may be enrolled without a 2-year restriction.
* Evidence of cardiovascular risk as per the protocol criteria.
* Pregnant or lactating female.
* Active infection requiring antibiotic, antiviral, or antifungal treatment.
* Known human immunodeficiency virus (HIV) infection, unless the criteria in protocol can be met.
* Hepatitis B and C will be excluded unless the criteria in protocol can be met.
* Cirrhosis or current unstable liver or biliary disease.
* Alanine aminotransferase (ALT) >2.5× upper limit of normal (ULN).
* Total Bilirubin >1.5×ULN.
* Systemic anti-MM therapy within <=14 days or 5 half-lives, whichever is shorter.
* Systemic therapy with high dose steroids within <=14 days before the first dose of study treatment.
* Prior allogenic stem cell transplant.
* Prior treatment with a monoclonal antibody <=30 days before the first dose of study treatment. Use of monoclonal antibodies for serious conditions unrelated to multiple myeloma, such as COVID, may be permitted.
* Prior treatment with an anti-B cell maturation antigen (BCMA) targeted therapy or hypersensitivity reactions to any components of the study treatment.
* Treatment with an antibody-drug conjugate.
* Participant has received any major surgery <=4 weeks before the first dose of study treatment. An exception may be allowed for bone stabilizing surgery.
* Inadequate bone marrow reserve or organ functions as demonstrated by any of the following: a. Absolute neutrophil count <1.0×10^9/L, b. Hemoglobin <8 gram/deciliter (g/dL), c. Platelet count <50×10^9/L, d. Spot urine (albumin/creatinine ratio) >500 milligram/gram (mg/g), e. Estimated glomerular filtration rate (eGFR) <30 milliliter per minute per 1.73 meter square (mL/min/1.73m^2).
* UK specific: a. Absolute neutrophil count <1.5×10^9/L, c. Platelet count <75×10^9/L

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
10/02/2025
Actual
Sample size
Target
Accrual to date
Final
177
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Liverpool
Recruitment hospital [2] 0 0
GSK Investigational Site - Waratah
Recruitment hospital [3] 0 0
GSK Investigational Site - Woodville
Recruitment hospital [4] 0 0
GSK Investigational Site - East Melbourne
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
5011 - Woodville
Recruitment postcode(s) [4] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Missouri
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Tennessee
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
Argentina
State/province [6] 0 0
Buenos Aires
Country [7] 0 0
Argentina
State/province [7] 0 0
Santa Fe
Country [8] 0 0
Argentina
State/province [8] 0 0
Ciudad Autonoma de Buenos Aires
Country [9] 0 0
Brazil
State/province [9] 0 0
Bahía
Country [10] 0 0
Brazil
State/province [10] 0 0
Rio Grande Do Sul
Country [11] 0 0
Brazil
State/province [11] 0 0
Santa Catarina
Country [12] 0 0
Brazil
State/province [12] 0 0
Rio de Janeiro
Country [13] 0 0
Brazil
State/province [13] 0 0
São Paulo
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
Canada
State/province [15] 0 0
Quebec
Country [16] 0 0
France
State/province [16] 0 0
Avignon cedex 9
Country [17] 0 0
France
State/province [17] 0 0
Le Mans
Country [18] 0 0
France
State/province [18] 0 0
Nice Cedex 2
Country [19] 0 0
France
State/province [19] 0 0
Orléans
Country [20] 0 0
France
State/province [20] 0 0
Saint-Priest en Jarez
Country [21] 0 0
Germany
State/province [21] 0 0
Brandenburg
Country [22] 0 0
Germany
State/province [22] 0 0
Mecklenburg-Vorpommern
Country [23] 0 0
Germany
State/province [23] 0 0
Sachsen
Country [24] 0 0
Germany
State/province [24] 0 0
Hamburg
Country [25] 0 0
Greece
State/province [25] 0 0
Athens
Country [26] 0 0
Greece
State/province [26] 0 0
Haidari, Athens
Country [27] 0 0
Greece
State/province [27] 0 0
Rio/Patras
Country [28] 0 0
Greece
State/province [28] 0 0
Thessaloniki
Country [29] 0 0
India
State/province [29] 0 0
Maharashtra
Country [30] 0 0
India
State/province [30] 0 0
Ahmedabad
Country [31] 0 0
India
State/province [31] 0 0
Bangalore
Country [32] 0 0
India
State/province [32] 0 0
Hyderabad
Country [33] 0 0
India
State/province [33] 0 0
Jaipur
Country [34] 0 0
India
State/province [34] 0 0
Kerala
Country [35] 0 0
India
State/province [35] 0 0
Kolkata
Country [36] 0 0
India
State/province [36] 0 0
Mumbai
Country [37] 0 0
India
State/province [37] 0 0
Pondicherry
Country [38] 0 0
India
State/province [38] 0 0
Pune
Country [39] 0 0
Ireland
State/province [39] 0 0
Dublin
Country [40] 0 0
Italy
State/province [40] 0 0
Emilia-Romagna
Country [41] 0 0
Italy
State/province [41] 0 0
Liguria
Country [42] 0 0
Italy
State/province [42] 0 0
Marche
Country [43] 0 0
Italy
State/province [43] 0 0
Piemonte
Country [44] 0 0
Italy
State/province [44] 0 0
Cagliari
Country [45] 0 0
Korea, Republic of
State/province [45] 0 0
Busan
Country [46] 0 0
Korea, Republic of
State/province [46] 0 0
Hwasun-gun, Jeollanam-do
Country [47] 0 0
Korea, Republic of
State/province [47] 0 0
Seoul
Country [48] 0 0
Mexico
State/province [48] 0 0
Ciudad De Mexico
Country [49] 0 0
Poland
State/province [49] 0 0
Bydgoszcz
Country [50] 0 0
Poland
State/province [50] 0 0
Gdansk
Country [51] 0 0
Poland
State/province [51] 0 0
Katowice
Country [52] 0 0
Poland
State/province [52] 0 0
Lublin
Country [53] 0 0
Poland
State/province [53] 0 0
Nowy Sacz
Country [54] 0 0
Poland
State/province [54] 0 0
Poznan
Country [55] 0 0
Poland
State/province [55] 0 0
Torun
Country [56] 0 0
Poland
State/province [56] 0 0
Walbrzych
Country [57] 0 0
Poland
State/province [57] 0 0
Warszawa
Country [58] 0 0
Poland
State/province [58] 0 0
Wroclaw
Country [59] 0 0
Spain
State/province [59] 0 0
Asturias
Country [60] 0 0
Spain
State/province [60] 0 0
Albacete
Country [61] 0 0
Spain
State/province [61] 0 0
Barcelona
Country [62] 0 0
Spain
State/province [62] 0 0
Cordoba
Country [63] 0 0
Spain
State/province [63] 0 0
Gerona
Country [64] 0 0
Spain
State/province [64] 0 0
Lleida
Country [65] 0 0
Spain
State/province [65] 0 0
Terrassa (Barcelona)
Country [66] 0 0
Spain
State/province [66] 0 0
Valencia
Country [67] 0 0
Switzerland
State/province [67] 0 0
Bern
Country [68] 0 0
Taiwan
State/province [68] 0 0
Taichung
Country [69] 0 0
Taiwan
State/province [69] 0 0
Tainan
Country [70] 0 0
Taiwan
State/province [70] 0 0
Taipei
Country [71] 0 0
Thailand
State/province [71] 0 0
Bangkok
Country [72] 0 0
Thailand
State/province [72] 0 0
Chiang Mai
Country [73] 0 0
Thailand
State/province [73] 0 0
Khon Kaen
Country [74] 0 0
United Kingdom
State/province [74] 0 0
Staffordshire
Country [75] 0 0
United Kingdom
State/province [75] 0 0
Leicester
Country [76] 0 0
United Kingdom
State/province [76] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
IPD for this study will be made available via the Clinical Study Data Request site.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
Available to whom?
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://clinicalstudydatarequest.com


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05064358