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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
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 - Bela
Treatment: Drugs - Belamaf
Treatment: Drugs - Lenalidomide
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Standard of Care

Experimental: Part 1 - Dose Escalation Phase in Participants with RRMM - Bela will be administered in participants with RRMM until progressive disease (PD). Participants may switch to Belamaf in case of PD.

Experimental: Part 2 - Combination Treatments in Participants with RRMM - Participants with RRMM will receive Bela-xRd and Belamaf-xRd. The combination treatment xRd includes lenalidomide (R) and dexamethasone (d). x will be either a standard of care (SoC) or an emerging treatment for Multiple Myeloma.

Experimental: Part 3 - Combination Treatments in Participants with TI-NDMM - Participants with TI-NDMM will receive Bela-xRd and Belamaf-xRd. The combination treatment xRd includes lenalidomide (R) and dexamethasone (d). x will be either a standard of care (SoC) or an emerging treatment for Multiple Myeloma.


Treatment: Drugs: Bela
Bela will be administered.

Treatment: Drugs: Belamaf
Belamaf will be administered.

Treatment: Drugs: Lenalidomide
Lenalidomide will be administered.

Treatment: Drugs: Dexamethasone
Dexamethasone will be administered.

Treatment: Drugs: Standard of Care
Either standard of care (SoC) or an emerging treatment for Multiple Myeloma will be administered
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part 1, 2 and 3: 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, 2 and 3: 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 2 and 3: Number of Participants with Corneal Adverse Events (CAEs)
Timepoint [4] 0 0
Up to 52 months
Secondary outcome [1] 0 0
Part 1, 2 and 3: Observed Plasma Concentration of Bela
Timepoint [1] 0 0
Up to 52 months
Secondary outcome [2] 0 0
Part 1, 2 and 3: Area Under the Curve (AUC) of Bela
Timepoint [2] 0 0
Up to 52 months
Secondary outcome [3] 0 0
Part 1, 2 and 3: Maximum Concentration (Cmax) of Bela
Timepoint [3] 0 0
Up to 52 months
Secondary outcome [4] 0 0
Part 1, 2 and 3: Number of Participants with Anti-Drug Antibodies (ADA) against Bela
Timepoint [4] 0 0
Up to 52 months
Secondary outcome [5] 0 0
Part 1, 2 and 3: Titers of ADA against Bela
Timepoint [5] 0 0
Up to 52 months
Secondary outcome [6] 0 0
Part 2 and 3: Number of Participants with ADAs against Belamaf
Timepoint [6] 0 0
Up to 52 months
Secondary outcome [7] 0 0
Part 2 and 3: Titers of ADAs against Belamaf
Timepoint [7] 0 0
Up to 52 months
Secondary outcome [8] 0 0
Part 1, 2 and 3: Objective Response Rate (ORR)
Timepoint [8] 0 0
Up to 52 months
Secondary outcome [9] 0 0
Part 2 and 3: Stringent Complete Response (sCR) Rate
Timepoint [9] 0 0
Up to 52 months
Secondary outcome [10] 0 0
Part 2 and 3: Complete Response (CR) Rate
Timepoint [10] 0 0
Up to 52 months
Secondary outcome [11] 0 0
Part 2 and 3: Very Good Partial Response (VGPR) Rate
Timepoint [11] 0 0
Up to 52 months
Secondary outcome [12] 0 0
Part 2 and 3: Observed Plasma Concentration of Belamaf
Timepoint [12] 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 IMWG, and measurable disease.
* PART 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). Lines of therapy are defined by consensus panel of the International Myeloma Workshop.
* PART 2: Participants who meet all of the following:
* Have undergone Autologous stem cell transplant (ASCT) or are considered transplant ineligible
* Have been previously treated with at least ONE prior line of MM therapy
* Have documented disease progression during or after their most recent therapy
* PART 3: Participants who meet both of the following:
* NDMM with a requirement for treatment as documented per IMWG criteria
* Not considered a candidate for high dose chemotherapy with ASCT due to:

1. Age = 65 years OR
2. Age 18-65 years with presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT or who refuse high-dose chemotherapy with ASCT as an initial treatment.
* Participants capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and 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.
* Active infection requiring antibiotic, antiviral, or antifungal 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
14/06/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
29/02/2028
Actual
Sample size
Target
124
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
Buenos Aires
Country [2] 0 0
Brazil
State/province [2] 0 0
Bahía
Country [3] 0 0
Brazil
State/province [3] 0 0
São Paulo
Country [4] 0 0
Japan
State/province [4] 0 0
Aomori
Country [5] 0 0
Japan
State/province [5] 0 0
Osaka
Country [6] 0 0
Korea, Republic of
State/province [6] 0 0
Seoul, Korea
Country [7] 0 0
Korea, Republic of
State/province [7] 0 0
Seoul
Country [8] 0 0
Mexico
State/province [8] 0 0
Mexico City
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
Kayseri
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Leicester
Country [15] 0 0
United Kingdom
State/province [15] 0 0
Oxford.

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
[email protected]
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