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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05714839




Registration number
NCT05714839
Ethics application status
Date submitted
27/01/2023
Date registered
6/02/2023

Titles & IDs
Public title
A Study to Investigate the Safety and Efficacy of Belantamab for the Treatment of Multiple Myeloma When Used as Monotherapy and in Combination Treatments
Scientific title
A Phase 1/2 Open-label, Multicentre, Dose Escalation and Expansion Study to Investigate the Safety, Tolerability, and Clinical Activity of Belantamab as Monotherapy and in Combination With Other Treatments in Participants With Multiple Myeloma
Secondary ID [1] 0 0
2022-501941-63-00
Secondary ID [2] 0 0
218670
Universal Trial Number (UTN)
Trial acronym
DREAMM-20
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
Treatment: Drugs - Belantamab mafodotin
Treatment: Drugs - Belantamab and belantamab mafodotin

Experimental: Part 1: Dose escalation of belantamab monotherapy - Belantamab will be administered in participants with RRMM until progressive disease (PD)

Experimental: Part 2: Belantamab and belantamab mafodotin (delivered as separate drugs) dose range finding - Participants with RRMM will receive belantamab in combination with a fixed dose of belantamab mafodotin (delivered as separate drugs)

Experimental: Part 1b: Optional belantamab mafodotin - Participants enrolled in Part 1 and Part 2 will be dosed until PD after which they will have the option to receive treatment with single agent belantamab mafodotin.


Treatment: Drugs: Belantamab
Belantamab will be administered.

Treatment: Drugs: Belantamab mafodotin
Belantamab mafodotin will be administered.

Treatment: Drugs: Belantamab and belantamab mafodotin
Belantamab and belantamab mafodotin used in combination (delivered as separate drugs) will be administered.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part 1 and 2: Number of Participants with any Adverse Event
Timepoint [1] 0 0
Up to 52 months
Primary outcome [2] 0 0
Part 1: Number of Participants with Dose Limiting Toxicities (DLTs)
Timepoint [2] 0 0
Cycle 1 (Each cycle is of 28 days)
Primary outcome [3] 0 0
Part 1 and 2: Number of Participants with Worst Case Grade Change from Baseline in Laboratory and Vital Sign Parameters
Timepoint [3] 0 0
Up to 52 months
Primary outcome [4] 0 0
Part 1 and 2: Number of Participants with ocular events by the modified Keratopathy Visual Acuity (mKVA) scale
Timepoint [4] 0 0
Up to 52 months
Primary outcome [5] 0 0
Part 2: Overall Response Rate (ORR)
Timepoint [5] 0 0
Up to 52 months
Secondary outcome [1] 0 0
Part 1: Observed Plasma Concentration of belantamab
Timepoint [1] 0 0
Up to 52 months
Secondary outcome [2] 0 0
Part 1: Area Under the Curve (AUC) of belantamab
Timepoint [2] 0 0
Up to 52 months
Secondary outcome [3] 0 0
Part 1: Maximum Concentration (Cmax) of belantamab
Timepoint [3] 0 0
Up to 52 months
Secondary outcome [4] 0 0
Part 1: Number of Participants with Anti-Drug Antibodies (ADA) against belantamab
Timepoint [4] 0 0
Up to 52 months
Secondary outcome [5] 0 0
Part 1: Titers of ADA against belantamab
Timepoint [5] 0 0
Up to 52 months
Secondary outcome [6] 0 0
Part 1: Overall Response Rate (ORR)
Timepoint [6] 0 0
Up to 52 months
Secondary outcome [7] 0 0
Part 2: Duration of Response (DoR)
Timepoint [7] 0 0
Up to 52 months
Secondary outcome [8] 0 0
Part 2: Observed Plasma Concentration of Total belantamab
Timepoint [8] 0 0
Up to 52 months
Secondary outcome [9] 0 0
Part 2: Area Under the Curve (AUC) of Total belantamab
Timepoint [9] 0 0
Up to 52 months
Secondary outcome [10] 0 0
Part 1: Maximum Concentration (Cmax) of Total belantamab
Timepoint [10] 0 0
Up to 52 months
Secondary outcome [11] 0 0
Part 2: Observed Plasma Concentration of belantamab mafodotin antibody-drug conjugate (ADC)
Timepoint [11] 0 0
Up to 52 months
Secondary outcome [12] 0 0
Part 2: Area Under the Curve (AUC) of belantamab mafodotin (ADC)
Timepoint [12] 0 0
Up to 52 months
Secondary outcome [13] 0 0
Part 1: Maximum Concentration (Cmax) of belantamab mafodotin (ADC)
Timepoint [13] 0 0
Up to 52 months
Secondary outcome [14] 0 0
Part 2: Observed Plasma Concentration of Cys-Monomethyl Auristatin-F (Cys-mcMMAF)
Timepoint [14] 0 0
Up to 52 months
Secondary outcome [15] 0 0
Part 2: Area Under the Curve (AUC) of Cys-mcMMAF
Timepoint [15] 0 0
Up to 52 months
Secondary outcome [16] 0 0
Part 1: Maximum Concentration (Cmax) of Cys-mcMMAF
Timepoint [16] 0 0
Up to 52 months
Secondary outcome [17] 0 0
Part 2: Number of Participants with ADAs against belantamab and belantamab mafodotin
Timepoint [17] 0 0
Up to 52 months
Secondary outcome [18] 0 0
Part 2: Titers of ADAs against belantamab and belantamab mafodotin
Timepoint [18] 0 0
Up to 52 months

Eligibility
Key inclusion criteria
* Participants at the time of signing the Informed Consent Form (ICF) are at least 18 years old or are of the legal age of consent in the jurisdiction in which the study is taking place.
* Participants who have histologically or cytologically confirmed diagnosis of Multiple Myeloma (MM), as defined by the international myeloma working group (IMWG).

1. Participants who have received at least 3 prior lines of anti-myeloma treatments, and have already received an immunomodulating agent, a proteasome inhibitor, and an anti-CD38 mAb (unless contraindicated or unavailable) and have confirmed progression on or following the last line of treatment.
* Participants with a history of Autologous stem cell transplant (ASCT) are eligible for study participation provided the following eligibility criteria are met:

1. transplant was greater than (>)100 days prior to screening.
2. no active infection(s)
* Eastern cooperative oncology group-performance status (ECOG-PS) of 0 to 2.
* Measurable disease defined as at least ONE of the following:

1. Serum M-protein concentration greater than (>=) 0.5 gram (g)/ deciliter (dL) (>=5 gram/liter [g/L])
2. Urine M-protein excretion >=200 mg/24 hours (>=0.2 g/24 hours)
3. Serum free light chain (FLC) assay: involved FLC level >=10 mg/dL (>=100 milligrams per liter [mg/L]) and an abnormal serum FLC ratio (less than [<]0.26 or >1.65)
* Have adequate organ system function as defined by the laboratory assessments.
* All prior treatment-related toxicities (defined by National Cancer Institute-Common Toxicity Criteria for Adverse Events [NCI-CTCAE], v5.0, 2017) must be Grade <=1 at the time of screening except for alopecia (any grade), neuropathy (Grade <=2), or endocrinopathy managed with replacement therapy (any grade).
* Participants or Legally authorized representative (LAR) capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Diagnosis of primary Amyloid Light chain (AL) Amyloidosis, active Polyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin changes (POEMS) syndrome, primary plasma cell leukemia.
* 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 with study procedures.
* Participant is exhibiting signs of meningeal or central nervous system involvement with MM.
* Current corneal epithelial disease except nonconfluent Superficial punctate keratitis (SPK).
* Has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric varices, or persistent jaundice.
* Presence of 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 investigator (PI) and GlaxoSmithKline (GSK) Medical Director, will not affect the evaluation of the effects of this clinical trial treatment on the currently targeted malignancy (MM).
* Evidence of cardiovascular risk
* Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to belantamab / belantamab mafodotin or any of the components of the study treatment. History of severe hypersensitivity to other Monoclonal antibodies (mAbs).
* Active infection requiring antibiotic, antiviral, or antifungal treatment.
* Known Human immunodeficiency virus (HIV) infection, unless the participant can meet specific criteria.
* Recent history (within the past 6 months) of acute diverticulitis, inflammatory bowel disease, intra-abdominal abscess, or gastrointestinal obstruction.
* Participants with Hepatitis B virus (HBV) or Hepatitis C virus (HCV) will be excluded unless specific criteria can be met
* 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
* Refractory to belantamab mafodotin (confirmed PD as per IMWG criteria while on belantamab mafodotin therapy or within 60 days of completing that treatment). Prior belantamab mafodotin is allowed if it was discontinued due to toxicity which subsequently resolved.
* Prior radiotherapy within 2 weeks of start of study therapy.
* Plasmapheresis within 7 days prior to the first dose of study drug.
* Prior allogeneic transplant is prohibited.
* Participants who have received prior Chimeric Antigen Receptor T-cell therapy (CAR-T) therapy with lymphodepletion with chemotherapy within 3 months of screening.
* Any major surgery (other than bone-stabilizing surgery) within 2 weeks of first dose or has not recovered fully from surgery.
* Prior treatment with a mAb within 30 days of receiving the first dose of study drugs, or treatment with an investigational agent or approved systemic anti-myeloma therapy (including systemic steroids) within 14 days or 5 half-lives of receiving the first dose of study drugs, whichever is longer.
* Has received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including Granulocyte colony stimulating factor (G-CSF), Granulocyte-macrophage colony-stimulating factor (GMCSF), recombinant erythropoietin) or any thrombopoietin receptor agonists within 2 weeks before the first dose of study drug.
* Participants must not receive live/live attenuated vaccines within 30 days prior to first dose of study treatment or whilst receiving belantamab for at least 70 days following last study treatment.
* Known, current drug or alcohol abuse.
* Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this trial, unless prospective Independent Review Board (IRB) approval (by chair or designee) is allowing exception to this criterion for a specific participant.

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
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/05/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
19/09/2028
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Fitzroy
Recruitment hospital [2] 0 0
GSK Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Ciudadela
Country [2] 0 0
Argentina
State/province [2] 0 0
Viedma
Country [3] 0 0
Brazil
State/province [3] 0 0
Joinville
Country [4] 0 0
Brazil
State/province [4] 0 0
Salvador
Country [5] 0 0
Brazil
State/province [5] 0 0
SAo Paulo
Country [6] 0 0
Japan
State/province [6] 0 0
Aomori
Country [7] 0 0
Japan
State/province [7] 0 0
Osaka
Country [8] 0 0
Korea, Republic of
State/province [8] 0 0
Seoul
Country [9] 0 0
Poland
State/province [9] 0 0
Gdansk
Country [10] 0 0
Poland
State/province [10] 0 0
Lublin
Country [11] 0 0
Taiwan
State/province [11] 0 0
Changhua
Country [12] 0 0
Taiwan
State/province [12] 0 0
Taipei
Country [13] 0 0
Turkey
State/province [13] 0 0
Istanbul
Country [14] 0 0
Turkey
State/province [14] 0 0
Kayseri
Country [15] 0 0
United Kingdom
State/province [15] 0 0
Leicester
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Oxford
Country [17] 0 0
United Kingdom
State/province [17] 0 0
Plymouth

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
US GSK Clinical Trials Call Center
Address 0 0
Country 0 0
Phone 0 0
877-379-3718
Fax 0 0
Email 0 0
GSKClinicalSupportHD@gsk.com
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?
Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

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)?
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Available to whom?
Anonymized IPD is shared with researchers whose proposals are approved by an 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 may be granted, when justified, for up to 6 months.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.gsk.com/en-gb/innovation/trials/data-transparency/


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/NCT05714839