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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05064358




Registration number
NCT05064358
Ethics application status
Date submitted
22/09/2021
Date registered
1/10/2021
Date last updated
28/05/2024

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
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Cagliari
Country [45] 0 0
Korea, Republic of
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Busan
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Korea, Republic of
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Hwasun-gun, Jeollanam-do
Country [47] 0 0
Korea, Republic of
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Seoul
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Mexico
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Ciudad De Mexico
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Poland
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Bydgoszcz
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Gdansk
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Katowice
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Lublin
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Poland
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Nowy Sacz
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Poland
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Poznan
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Poland
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Torun
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Poland
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Walbrzych
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Poland
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Warszawa
Country [58] 0 0
Poland
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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
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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
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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
This study aims to evaluate alternative dosing regimens of single-agent belantamab mafodotin
in participants with relapsed or refractory multiple myeloma (RRMM) to determine if an
improved overall benefit/risk profile can be achieved by modifying the belantamab mafodotin
dose, schedule, or both.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05064358
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