A Phase III, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Single Agent Belantamab Mafodotin Compared to Pomalidomide Plus Lowdose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) (DREAMM 3)
ClinicalTrials.gov processed this data on May 24, 2024. Link to the current ClinicalTrials.gov record.Recruitment Status
ACTIVE, NOT RECRUITING - HAS RESULTS(See Contacts and Locations)
Verified May 2024 by GlaxoSmithKline
Sponsor
GlaxoSmithKlineInformation Provided by (Responsible Party)
GlaxoSmithKlineClinicaltrials.gov Identifier
NCT04162210Other Study ID Numbers: 207495
First Submitted: November 11, 2019
First Posted: November 14, 2019
Results First Posted: October 6, 2023
Last Update Posted: June 10, 2024
Last Verified: May 2024
History of Changes
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Study Description
Not ProvidedCondition or Disease | Intervention/Treatment |
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Study Design
Study Type | Interventional |
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Actual Enrollment | 325 participants |
Design Allocation | Randomized |
Interventional Model | Parallel Assignment |
Masking | None (Open Label) |
Primary Purpose | Treatment |
Official Title | A Phase III, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Single Agent Belantamab Mafodotin Compared to Pomalidomide Plus Lowdose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) (DREAMM 3) |
Study Start Date | April 2, 2020 |
Actual Primary Completion Date | September 12, 2022 |
Anticipated Study Completion Date | June 26, 2025 |
Groups and Cohorts
Group/ Cohort | Intervention/ Treatment |
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Outcome Measures
Primary Outcome Measures
- Progression-free Survival (PFS) Based on Investigator-assessed Response as Per International Myeloma Working Group (IMWG) [Up to 27 months] PFS is time from randomization until earliest date of progressive disease (PD), or death due to any cause per investigator-assessed response per IMWG. PD is ≥25% increase from nadir in any of following: serum M-protein (absolute increase ≥0.5 gram per deciliter [g/dL]),urine M-protein(absolute increase ≥200 mg/24hr),difference between involved/uninvolved FLC levels (absolute increase >10 mg/dL) in patients without measurable serum and urine M-protein levels, or bone marrow plasma-cell percentage irrespective of baseline status (absolute increase ≥10%) in patients without measurable serum and urine M-protein levels and without measurable involved FLC levels; appearance of new lesion,≥50% increase in longest diameter of a lesion previously measured >1cm in short axis, or ≥50% increase from nadir in sum of products of two longest perpendicular diameters of more than 1 lesion; ≥50% increase in circulating plasma cells (minimum of 200 cells/microliter) if this is only measure of disease.
Secondary Outcome Measures
- Overall Survival (OS) [60 months] OS is defined as the time from randomization until death due to any cause.
- Overall Response Rate (ORR) [Up to 55 months] ORR is defined as the percentage of participants with a confirmed partial response (PR) or better per IMWG.
- Clinical Benefit Rate (CBR) [Up to 55 months] CBR is defined as the percentage of participants with a confirmed minimal response (MR) or better per IMWG.
- Duration of Response (DoR) [Up to 55 months] DoR is defined as the time from first documented evidence of PR or better until progressive disease (PD) per IMWG or death due to PD among participants who achieve confirmed PR or better.
- Time to Response (TTR) [Up to 55 months] TTR is defined as the time between the date of randomization and the first documented evidence of response (PR or better) among participants who achieve confirmed PR or better.
- Time to Progression (TTP) [Up to 55 months] TTP is defined as the time from the date of randomization until the earliest date of documented PD (per IMWG Response Criteria) or death due to PD.
- Number of Participants With Adverse Events (AEs) [Up to 55 months] An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment.
- Change From Baseline in Hematology Parameters: Absolute White Blood Cell Count (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, and Neutrophils (Giga Cells Per Liter) [Baseline and up to 55 months] Blood samples will be collected for the analysis of hematology parameters.
- Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count and Reticulocyte Count (Trillion Cells Per Liter) [Baseline and up to 55 months] Blood samples will be collected for the analysis of hematology parameters.
- Change From Baseline in Hematology Parameters: Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Grams Per Liter) [Baseline and up to 55 months] Blood samples will be collected for the analysis of hematology parameters.
- Change From Baseline in Hematology Parameters: Hematocrit (Proportion of Red Blood Cells in Blood) [Baseline and up to 55 months] Blood samples will be collected for the analysis of hematology parameters.
- Change From Baseline in Hematology Parameters: Mean Corpuscular Volume (MCV) [Femtoliter] [Baseline and up to 55 months] Blood samples will be collected for the analysis of hematology parameters.
- Change From Baseline in Hematology Parameters: Mean Corpuscular Hemoglobin (MCH) [Picograms] [Baseline and up to 55 months] Blood samples will be collected for the analysis of hematology parameters.
- Change From Baseline in Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) [Baseline and up to 55 months] Blood samples will be collected for the analysis of clinical chemistry parameters like ALT, AST, ALP, CK, GGT, and LDH [International units per Liter
- Change From Baseline in Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Magnesium, Blood Urea Nitrogen (BUN), and Phosphorous (Millimoles Per Liter) [Baseline and up to 55 months] Blood samples will be collected for the analysis of clinical chemistry parameters.
- Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Total Bilirubin, Uric Acid (Micromoles Per Liter) [Baseline and up to 55 months] Blood samples will be collected for the analysis of clinical chemistry parameters.
- Change From Baseline in Clinical Chemistry Parameters: Albumin and Total Protein (Grams Per Liter) [Baseline and up to 55 months] Blood samples will be collected for the analysis of clinical chemistry parameters.
- Change From Baseline in Urinalysis Parameter: Specific Gravity (Ratio) [Baseline and up to 55 months] Urine samples will be collected for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity.
- Change From Baseline in Urinalysis Parameters- Urine Potential of Hydrogen (pH) (Points on a Scale) [Baseline and up to 55 months] Urine samples will be collected for the assessment of Urinary pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).
- Change From Baseline in Urinalysis Parameter: Glucose (Millimole Per Liter) [Baseline and up to 55 months] Urine samples will be collected for the assessment of urinary glucose.
- Change From Baseline in Urinalysis Parameter: Protein (Grams Per Liter) [Baseline and up to 55 months] Urine samples will be collected for the assessment of urinary protein.
- Change From Baseline in Urinalysis Parameter: Ketones (Millimoles Per Liter) [Baseline and up to 55 months] Urine samples will be collected for the assessment of urinary ketones.
- Change From Baseline in Urinalysis Parameter: Blood (10^9 Cells Per Liter) [Baseline and up to 55 months] Urine samples will be collected for the assessment of urinary blood.
- Change From Baseline in Urinalysis Parameter: Creatinine/Albumin Ratio (Ratio) [Baseline and up to 55 months] Urine samples will be collected for the assessment of urinary creatinine/albumin ratio.
- Number of Participants With Abnormal Ocular Findings [Up to 55 months] Participants will be assessed for any abnormal ocular findings.
- Plasma Concentrations of Belantamab Mafodotin [Up to 55 months] Blood samples will be collected for the analysis.
- Plasma Concentrations of Total Monoclonal Antibody (mAb) [Up to 55 months] Blood samples will be collected for the analysis.
- Plasma Concentrations of Cys-mc Microtubular Inhibitor Monomethyl Auristatin-F (MMAF) [Up to 55 months] Blood samples will be collected for the analysis.
- Number of Participants With Anti-drug Antibody (ADAs) Against Belantamab Mafodotin [Up to 55 months] Blood samples will be collected for the analysis.
- Titer of ADAs Against Belantamab Mafodotin [Up to 55 months] Blood samples will be collected for the analysis.
- Number of Participants With Symptomatic Adverse Effects Measured by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) [Up to 55 months] PRO-CTCAE is a patient-reported outcome measure developed to evaluate symptomatic toxicity in participants on cancer clinical trials. The PRO-CTCAE includes an item library of 124 items representing 78 symptomatic toxicities drawn from the CTCAE.
- Number of Participants With Symptomatic Adverse Effects Measured by Ocular Surface Disease Index (OSDI) [Up to 55 months] OSDI is a 12-item questionnaire designed to assesses both the frequency of dry eye symptoms and their impact on vision-related functioning. It is graded on a scale of 0-4, with 0 indicating none of the time, 1 for some of the time, 2 for half of the time, 3 for most of the time and 4 indicating all the time. A higher score represents greater symptoms severity.
- European Organization for Research and Treatment of Cancer IL52 (EORTC IL52) Score [Up to 55 months] The EORTC Quality of Life Questionnaire 20-item Multiple Myeloma module (QLQMY20) is a supplement to the QLQ-C30 instrument used in participants with multiple myeloma. For the EORTC IL52, disease symptoms domain of the QLQ-MY20 will be used for bone aches or pain, back pain, hip pain, arm or shoulder pain, chest pain, and pain increasing with activity. The individual component scores in the disease symptom domain are averaged and transformed linearly to a score ranging from 0 to100. A high score for disease symptoms represents a high level of symptomatology or problems. A high score represents a high/healthy level of functioning.
- Rate of Minimal Residual Disease (MRD) [Up to 55 months] MRD negativity rate, defined as; the percentage of participants who are MRD negative by Next generation sequencing (NGS) method.
Eligibility Criteria
Ages Eligible for Study | 18 Years and Older (Adult, Older Adult) |
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Sexes Eligible for Study | All |
Accepts Healthy Volunteers | No |
Inclusion Criteria |
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Exclusion Criteria |
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Contacts and Locations
Sponsors and Collaborators | GlaxoSmithKline |
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Locations |
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Investigators |
Study Documents (Full Text)
- Documents Provided by GlaxoSmithKline: Study Protocol September 7, 2022
- Documents Provided by GlaxoSmithKline: Statistical Analysis Plan September 2, 2022
More Information
Additional Relevant MeSH Terms
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Neoplasms by Histologic Type
- Neoplasms
- Hemostatic Disorders
- Vascular Diseases
- Cardiovascular Diseases
- Paraproteinemias
- Blood Protein Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Immune System Diseases