TriangleNCT04162210 · REGISTRY CONDITION SEARCH
Study of Single Agent Belantamab Mafodotin Versus Pomalidomide Plus Low-dose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- PHASE3
- Status at capture
- ACTIVE NOT RECRUITING
- Registry last update
- 2026-07-01
This open-label, randomized study for evaluating the efficacy and safety of single agent belantamab mafodotin when compared to pom/dex in participants with RRMM. Participants will be randomized in a 2:1 ratio to receive either single agent belantamab mafodotin or pom/dex. Belantamab mafodotin will be administered on Day 1 (D1) at every 3 weeks (Q3W) schedule. Pomalidomide will be administered daily on Days 1 to 21 of each 28-day cycle, with dexamethasone administered once weekly (Days 1, 8, 15, and 22). Participants in both arms will be treated until disease progression, death, unacceptable toxicity, withdrawal of consent, and lost to follow-up or end of study, whichever comes first.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Overall Survival (OS)
Overall Response Rate (ORR)
Clinical Benefit Rate (CBR)
Duration of Response (DoR)
Time to Response (TTR)
Time to Progression (TTP)
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-baseline Relative to Baseline
Number of Participants With Maximum Grade Increase Post-Baseline Relative to Baseline in Hematology
Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-baseline Relative to Baseline
Number of Participants With Maximum Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry
Number of Participants With Shift in Urine Albumin Creatinine Ratio From Baseline to Worst Post-Baseline
Number of Participants With Maximum Worst-case Change From Baseline in Best Corrected Visual Acuity Test (BCVA) Scores
Observed Plasma Concentrations of Belantamab Mafodotin- Antibody-drug Conjugate (ADC)
Observed Plasma Concentrations of Belantamab Mafodotin- Total Monoclonal Antibody (mAb)
Observed Plasma Concentrations of Belantamab Mafodotin-Cys-mc Microtubular Inhibitor Monomethyl Auristatin-F (MMAF)
Number of Participants With Post-baseline Positive Anti-Drug Antibody (ADAs) Against Belantamab Mafodotin
Titers of ADAs Against Belantamab Mafodotin
Number of Participants With Symptomatic Adverse Effects as Measured by the Patient Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Change From Baseline (CFB) in Ocular Surface Disease Index (OSDI) Total Score
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score.
Change From Baseline (CFB) in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score
Change From Baseline (CFB) in EORTC IL52 Score
Number of Participants With Minimal Residual Disease (MRD) Negativity Rate
Progression-Free Survival (PFS) Based on Investigator-Assessed Response as Per International Myeloma Working Group (IMWG)
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion Criteria: * Capable of giving signed informed consent. * Participants must be 18 or older, at the time of signing the informed consent. In Republic of Korea, participants must be over 19 years of age inclusive, at the time of signing informed consent. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. * Histologically or cytologically confirmed diagnosis of Multiple myeloma (MM) as defined according to IMWG, and : Has undergone autologous stem cell transplant (SCT), or is considered transplant ineligible; Has received at least 2 prior lines of anti-myeloma treatments, including at least 2 consecutive cycles of both lenalidomide and a proteasome inhibitor (given separately or in combination), and must have documented disease progression on, or within 60 days of, completion of the last treatment or must be non-responsive while on last treatment, where non-responsive is defined as not achieving at least Minimal Response (MR) after 2 complete treatment cycles. In such cases lack of achieving of at least MR must be determined no earlier than at least 4 weeks after the last treatment. * Has measurable disease with at least one of the following: Serum M-protein \>=0.5 gram per deciliter (g/dL) (\>=5 gram per Liter); Urine M-protein \>=200 mg/24 hours; Serum free light chain (FLC) assay: Involved FLC level \>=10 milligram per deciliter (mg/dL) (\>=100 mg/L) and an abnormal serum FLC ratio (\<0.26 or \>1.65). * Participants with a history of autologous SCT are eligible for study participation provided the following eligibility criteria are met: Transplant was \>100 days prior to initiating study treatment; No active infection(s). * Adequate organ system functions as defined: Absolute neutrophil count (ANC) \>=1.0\*10\^9/L; Hemoglobin \>= 8.0 g/dL; Platelets \>= 50x10\^9/L; Total bilirubin \<=1.5\* Upper limit of normal (ULN) (isolated bilirubin \>1.5\*ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35 percent); ALT \<=2.5\*ULN; Estimated glomerular filtration rate (eGFR) \>=30 milliliter per minute per 1.73 square meter (mL/min/1.73 m\^2); Spot urine (albumin/creatinine ratios) \<=500 milligram per gram (mg/g) (56 milligram per millimoles \[mg/mmol\]). * Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Male participants are eligible to participate if they agree to the following during the intervention period and until 6 months after the last dose of study intervention to allow for clearance of any altered sperm: Refrain from donating sperm PLUS, either: Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR Must agree to use contraception/barrier as detailed below depending on whether they are randomised to Arm 1 (belantamab mafodotin) or Arm 2 (pom/dex), even if they have undergone a successful vasectomy: Agree to use a male condom throughout study treatment including the 6 month follow-up period even if they have undergone a successful vasectomy and a female partner to use an additional highly effective contraceptive method with a failure rate of \<1 percent per year when having sexual intercourse with a pregnant woman or a woman of childbearing potential who is not currently pregnant. Four weeks for male participants on Treatment Arm 2 (pom/dex). * A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) OR Is a WOCBP and agrees to abide by the following: Arm 1 (belantamab mafodotin): Use a contraceptive method that is highly effective (with a failure rate of \<1 percent per year) which includes abstinence, preferably with low user dependency during the intervention period and for 4 months after the last dose of study treatment. Arm 2 (pom/dex): Due to pomalidomide being a thalidomide analogue with risk for embryofetal toxicity and prescribed under a pregnancy prevention/controlled distribution program, WOCBP participants will be eligible if they commit either to abstain continuously from heterosexual sexual intercourse or to use two methods of reliable birth control (one method that is highly effective), beginning 4 weeks prior to initiating treatment with pomalidomide, during therapy, during dose interruptions and continuing for at least 4 weeks following discontinuation of pomalidomide treatment. Two negative pregnancy tests must be obtained prior to initiating therapy. The first test should be performed within 10-14 days and the second test within 24 hours prior to prescribing pomalidomide therapy. And agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should confirm the effectiveness of the contraceptive method(s) ahead of the first dose of study intervention. * All prior treatment-related toxicities (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events \[NCI-CTCAE\], version 5.0, 2017) must be \<=Grade 1 at the time of enrollment, except for alopecia and Grade 2 peripheral neuropathy. Exclusion Criteria: * Symptomatic amyloidosis, active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin changes); active plasma cell leukemia at the time of screening. * Systemic anti-myeloma therapy or use of an investigational drug within \<14 days or 5 half-lives, whichever is shorter, before the first dose of study intervention. * Prior treatment with an anti-MM monoclonal antibody within 30 days prior to receiving the first dose of study intervention. * Prior B cell maturation antigen (BCMA)-targeted therapy or prior pomalidomide treatment. * Plasmapheresis within 7 days prior to the first dose of study intervention. * Prior allogeneic stem cell transplant. (Participants who have undergone syngeneic transplant will be allowed only if no history of, or currently active, Graft-Versus-Host Disease \[GvHD\]). * Any major surgery within the last 4 weeks. * 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, provided they fulfil criteria as described in inclusion criteria. * 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. * History of (non-infectious) pneumonitis that required steroids, or current pneumonitis. * Evidence of active mucosal or internal bleeding. * Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. (Stable chronic liver disease \[including Gilbert's syndrome or asymptomatic gallstones\] or hepatobiliary involvement of malignancy is acceptable if participant otherwise meets entry criteria) * Participants with previous or concurrent malignancies other than multiple myeloma are excluded, unless the second malignancy has been considered medically stable for at least 2 years. The participant must not be receiving active therapy, other than hormonal therapy for this disease. (Participants with curatively treated non-melanoma skin cancer are allowed without a 2-year restriction). * Evidence of cardiovascular risk including any of the following: Evidence of current clinically significant uncontrolled arrhythmias including clinically significant electrocardiogram (ECG) abnormalities including 2nd degree (Mobitz Type II) or 3rd degree atrioventricular block; History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within 3 months of Screening; Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system; Uncontrolled hypertension. * Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to belantamab mafodotin, pomalidomide, dexamethasone or any of the components of the study intervention. * Pregnant or lactating female. * Active infection requiring treatment. * Known human immunodeficiency virus (HIV), unless the participant can meet all of the following criteria: Established anti-retroviral therapy (ART) for at least 4 weeks and HIV viral load \<400 copies/mL; CD4+ T-cell (CD4+) counts ≥350 cells/uL; No history of AIDS-defining opportunistic infections within the last 12 months.(Consideration must be given to ART and prophylactic antimicrobials that may have a drug-drug interaction and/or overlapping toxicities with belantamab mafodotin or other combination products as relevant) * Participants with Hepatitis B will be excluded unless the following criteria can be met: If the participant is hepatitis B core antibody (HbcAb) positive or hepatitis B surface antigen (HbsAg) negative, then hepatitis B virus (HBV) deoxyribonucleic acid (DNA) should be undectectable at the time of screening; If HbsAg+ at screening or \<=3 months prior to first dose of study treatment, then HBV DNA should be undetectable, highly effective antiviral treatment should be started ≥4 weeks prior to first dose of study treatment, exclusion of participants with cirrhosis and participants in Japan must test hepatitis B e antigen (HBeAg) and hepatitis B e antibody (HBeAb ). * Positive hepatitis C antibody test result or positive hepatitis C Ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study treatment unless the participant can meet the following criteria: Hepatitis C RNA test negative at Screening and successful anti-viral treatment (usually 8 weeks duration) is required, followed by a negative HCV RNA test after a washout period of at least 4 weeks (Hepatitis RNA is optional and participants with negative Hepatitis C antibody test are not required to also undergo Hepatitis C RNA testing). * Participants unable to tolerate thromboembolic prophylaxis. * Current corneal epithelial disease except for mild punctate keratopathy.
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Participants will receive belantamab mafodotin single agent dose on Day 1 of Q3W
- intervention Names
- Drug: Belantamab mafodotin
- label
- Participants receiving Belantamab mafodotin
- type
- EXPERIMENTAL
- description
- Participants will receive pomalidomide daily on Days 1 to 21 of each 28-day cycle, with dexamethasone once weekly on Days 1, 8, 15 and 22.
- intervention Names
- Drug: Pom/dex (Pomalidomide plus low dose Dexamethasone)
- label
- Participants receiving pom/dex
- type
- ACTIVE_COMPARATOR
- interventions
- arm Group Labels
- Participants receiving Belantamab mafodotin
- description
- Belantamab mafodotin will be administered.
- name
- Belantamab mafodotin
- type
- DRUG
- arm Group Labels
- Participants receiving pom/dex
- description
- Pomalidomide and Dexamethasone will be administered.
- name
- Pom/dex (Pomalidomide plus low dose Dexamethasone)
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- intervention Model Description
- This is an open-label, randomized and multi-center study
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 325
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- 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.
- measure
- Progression-Free Survival (PFS) Based on Investigator-Assessed Response as Per International Myeloma Working Group (IMWG)
- time Frame
- Up to 27 months
- secondary Outcomes
- description
- OS is defined as the time from randomization until death due to any cause.
- measure
- Overall Survival (OS)
- time Frame
- Up to approximately 263 weeks
- description
- Overall Response Rate is defined as the percentage of participants with a confirmed partial response (PR) or better (i.e., PR, very good partial response \[VGPR\], complete response \[CR\] and stringent complete response \[sCR\]), according to the International Myeloma Working Group (IMWG) Response Criteria. PR: ≥50% reduction of serum M-protein and reduction in 24-hour (h) urinary M-protein by ≥90% or to \<200 mg/24-h; VGPR: serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component \<100 mg/24-h; CR:negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow; sCR:stringent complete response, CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.
- measure
- Overall Response Rate (ORR)
- time Frame
- Up to approximately 263 weeks
- description
- Clinical benefit rate is defined as the percentage of participants with a confirmed minimal response (MR) or better according to the IMWG Response Criteria. MR is \>= 25% but \< 49% reduction of serum M-protein and reduction in 24-hour urinary M-protein by 50-89%.
- measure
- Clinical Benefit Rate (CBR)
- time Frame
- Up to approximately 263 weeks
- description
- Duration of response is defined as the time from first documented evidence of PR or better, to the time when disease progression (PD) is documented per IMWG response criteria; or death due to PD occurs among participants who achieve an overall response, i.e. confirmed PR or better. PD= Increase of 25% from lowest confirmed response value in 1 or more of the following criteria: Serum M-protein with absolute increase of \>= 0.5 g/dL; Serum M-protein increase \>= 1 g/dL if the lowest M-component was \>=5 g/dL; Urinary M-protein (absolute increase must be \>= 200 mg per 24 h). PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to \<200 mg/24 h.
- measure
- Duration of Response (DoR)
- time Frame
- Up to approximately 263 weeks
- description
- 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. PR: \>=50% reduction of serum M-protein \& reduction in 24h urinary M-protein by \>=90%/\<200mg/24 h.
- measure
- Time to Response (TTR)
- time Frame
- Up to approximately 263 weeks
- description
- 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. PD: increase of \>=25% from lowest confirmed value in any 1 of following criteria: serum M-protein (absolute increase must be \>=0.5 g/dL), serum M-protein increase \>=1g/dL if lowest M component was \>=5g/dL; urine M-component (absolute increase must be \>=200mg/24 hour),appearance of new lesion(s), \>=50% increase from nadir in Sum of the Products of the maximal perpendicular Diameters of measured lesions (SPD) of \>1 lesion, or \>=50% increase in the longest diameter of previous lesion \>1 cm in short axis.
- measure
- Time to Progression (TTP)
- time Frame
- Up to approximately 263 weeks
- description
- 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. TEAE is an event that emerged during treatment having been absent pre-treatment or worsened relative to the pre-treatment state. AEs were to be coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.
- measure
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)
- time Frame
- Up to approximately 263 weeks
- description
- Blood samples were collected for evaluation of hematology parameters. The summaries of worst-case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. \[Basophils (Baso), Mean Corpuscular Hemoglobin Concentration (MCHC), Mean Corpuscular Hemoglobin (MCH), Mean Corpuscular Volume (MCV), Erythrocytes (Ery), Hematocrit (Hct), Monocytes (Mono), Reticulocytes (Ret), Leukocytes (Leu), Eosinophils (Eosi), Lymphocytes (Lym), Neutrophils (Neu)\]
- measure
- Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-baseline Relative to Baseline
- time Frame
- Baseline (Day 1) and up to approximately 263 weeks
- description
- Blood samples were collected for evaluation of hematology parameters. The summaries of maximum grade increase from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE version 5.0. Grade 1 (G1): mild; Grade 2 (G2): moderate; Grade 3 (G3): severe; Grade 4 (G4) life-threatening or disabling. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. \[White Blood Cells (WBC)\]
- measure
- Number of Participants With Maximum Grade Increase Post-Baseline Relative to Baseline in Hematology
- time Frame
- Baseline (Day 1) and up to approximately 263 weeks
- description
- Blood samples were collected for evaluation of clinical chemistry parameters. The summaries of worst-case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. \[Kappa Light (K Lt), Lambda (λ),Monoclonal (Mc), Protein (P), Change (Cge), Alpha (α), Beta (β), Creatine Kinase (CK), Gamma (γ) ,Immunoglobulin (I-Globulin), Indirect (In.)\]
- measure
- Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-baseline Relative to Baseline
- time Frame
- Baseline (Day 1) and up to approximately 263 weeks
- description
- Blood samples were collected for evaluation of clinical chemistry parameters. The summaries of maximum grade increase from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.Grade 1 (G1): mild; Grade 2 (G2): moderate; Grade 3 (G3): severe; Grade 4 (G4) life-threatening or disabling. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. \[Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Aspartate Aminotransferase (AST), Creatine Kinase (CPK), Gamma Glutamyl Transferase (GGT)\]
- measure
- Number of Participants With Maximum Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry
- time Frame
- Baseline (Day 1) and Up to approximately 263 weeks
- description
- Urine samples were analyzed for spot urine albumin/creatinine ratio (UACR)\[milligrams/grams (mg/g)\]. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. The "worst post-baseline value" is defined as the highest UACR measurement recorded for a participant after the baseline assessment and up to the end of the study observation period. The "shift" will be calculated as the difference between this worst post-baseline UACR value and the baseline UACR value (Worst Post-Baseline UACR - Baseline UACR). Each category is reported as "Baseline category, Worst post-baseline category." Ranges are inclusive and expressed as \[lower-upper\].
- measure
- Number of Participants With Shift in Urine Albumin Creatinine Ratio From Baseline to Worst Post-Baseline
- time Frame
- Baseline (Day 1) and Up to approximately 263 weeks
Full study description
- brief Summary
- This open-label, randomized study for evaluating the efficacy and safety of single agent belantamab mafodotin when compared to pom/dex in participants with RRMM. Participants will be randomized in a 2:1 ratio to receive either single agent belantamab mafodotin or pom/dex. Belantamab mafodotin will be administered on Day 1 (D1) at every 3 weeks (Q3W) schedule. Pomalidomide will be administered daily on Days 1 to 21 of each 28-day cycle, with dexamethasone administered once weekly (Days 1, 8, 15, and 22). Participants in both arms will be treated until disease progression, death, unacceptable toxicity, withdrawal of consent, and lost to follow-up or end of study, whichever comes first.
Source references
- references
- citation
- Dimopoulos MA, Hungria VTM, Radinoff A, Delimpasi S, Mikala G, Masszi T, Li J, Capra M, Maiolino A, Pappa V, Chraniuk D, Osipov I, Leleu X, Low M, Matsumoto M, Sule N, Li M, McKeown A, He W, Bright S, Currie B, Perera S, Boyle J, Roy-Ghanta S, Opalinska J, Weisel K. Efficacy and safety of single-agent belantamab mafodotin versus pomalidomide plus low-dose dexamethasone in patients with relapsed or refractory multiple myeloma (DREAMM-3): a phase 3, open-label, randomised study. Lancet Haematol. 2023 Oct;10(10):e801-e812. doi: 10.1016/S2352-3026(23)00243-0.
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Source notices and limitations
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Preserved source evidence · Not medical advice