Belantamab Mafodotin Plus Pomalidomide and Dexamethasone (Pd) Versus Bortezomib Plus Pd in Relapsed/Refractory Multiple Myeloma (DREAMM 8)
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ClinicalTrials.gov Identifier: NCT04484623 |
Recruitment Status :
Recruiting
First Posted : July 23, 2020
Last Update Posted : December 10, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Multiple Myeloma | Drug: Belantamab mafodotin Drug: Pomalidomide Drug: Dexamethasone Drug: Bortezomib | Phase 3 |
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 450 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Masking Description: | This is an open-label study; therefore, no blinding of treatment identity is needed. |
Primary Purpose: | Treatment |
Official Title: | A Phase III, Multicenter, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Pomalidomide and Dexamethasone (B-Pd) Versus Pomalidomide Plus Bortezomib and Dexamethasone (PVd) in Participants With Relapsed/Refractory Multiple Myeloma (DREAMM 8) |
Actual Study Start Date : | October 1, 2020 |
Estimated Primary Completion Date : | April 11, 2022 |
Estimated Study Completion Date : | January 1, 2027 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm A:Belantamab mafodotin plus Pomalidomide and Dexamethasone |
Drug: Belantamab mafodotin
Humanized anti-B-cell maturation antigen (BCMA) antibody/drug conjugate Drug: Pomalidomide Immunomodulatory imide drug (IMiD) Drug: Dexamethasone Synthetic glucocorticoid with anti-tumor activity |
Experimental: Arm B:Bortezomib plus Pomalidomide and Dexamethasone |
Drug: Pomalidomide
Immunomodulatory imide drug (IMiD) Drug: Dexamethasone Synthetic glucocorticoid with anti-tumor activity Drug: Bortezomib Proteasome Inhibitor |
- Progression-free survival (PFS) [ Time Frame: Up to 84 months ]Time from start of study treatment to the first documented disease progression or death due to any cause, whichever occurs first.
- Minimal residual disease (MRD) negativity rate [ Time Frame: Up to 84 months ]Percentage of participants who are MRD negative by next-generation sequencing.
- Overall response rate (ORR) [ Time Frame: Up to 84 months ]Percentage of participants with a confirmed partial response or better.
- Complete response rate (CRR) [ Time Frame: Up to 84 months ]Percentage of participants with a confirmed complete response or better.
- Very good partial response (VGPR) or better rate [ Time Frame: Up to 84 months ]Percentage of participants with a confirmed VGPR or better.
- Duration of response (DoR) [ Time Frame: Up to 84 months ]Time from first documented evidence of partial response or better to date of first documented progression or death, whichever occurs first.
- Time to best response (TTBR) [ Time Frame: Up to 84 months ]Time from the start of study treatment to the first documented evidence of best response among participants who achieve partial response or better.
- Time to response (TTR) [ Time Frame: Up to 84 months ]Time from the start of study treatment to the first documented evidence of response among participants who achieve partial response or better.
- Time to progression (TTP) [ Time Frame: Up to 84 months ]Time from the start of study treatment until the first documented date of disease progression or death, whichever occurs first.
- Overall survival (OS) [ Time Frame: Up to 84 months ]Time from randomization to death due to any cause.
- Progression-free survival on subsequent line of therapy (PFS2) [ Time Frame: Up to 84 months ]Time from start of study treatment to disease progression after initiation of new anti-cancer therapy or death from any cause, whichever occurs first.
- Number of participants with adverse events (AEs) [ Time Frame: Up to 84 months ]AEs will be collected.
- Number of participants with serious adverse events (SAEs) [ Time Frame: Up to 84 months ]SAEs will be collected.
- Number of participants with clinically significant changes in hematology, clinical chemistry and urinalysis lab parameters [ Time Frame: Up to 84 months ]Blood and urine samples will be collected for the assessment of hematology, clinical chemistry and urinalysis lab parameters.
- Number of participants with abnormal ocular findings on ophthalmic examination [ Time Frame: Up to 84 months ]Ophthalmic examination will assess abnormal findings.
- Plasma concentrations of belantamab mafodotin at indicated time points [ Time Frame: Up to 84 months ]Plasma concentrations of belantamab mafodotin in Arm A
- Plasma concentrations of total monoclonal antibody (mAb) at indicated time points [ Time Frame: Up to 84 months ]Plasma concentrations of total mAb in Arm A
- Plasma concentrations of monomethyl auristatin-F with a cysteine linker (cys-mcMMAF) at indicated time points [ Time Frame: Up to 84 months ]Plasma concentrations of cys-mcMMAF in Arm A
- Maximum observed concentration (Cmax) for pomalidomide [ Time Frame: Up to 24 hours ]Pharmacokinetic analysis of pomalidomide.
- Time of Cmax (Tmax) for pomalidomide [ Time Frame: Up to 24 hours ]Pharmacokinetic analysis of pomalidomide.
- Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC[0-t]) for pomalidomide [ Time Frame: Up to 24 hours ]Pharmacokinetic analysis of pomalidomide.
- Number of participants with positive anti-drug antibodies (ADAs) against belantamab mafodotin [ Time Frame: Up to 84 months ]Plasma concentrations of belantamab mafodotin ADAs in Arm A.
- Titers of ADAs against belantamab mafodotin [ Time Frame: Up to 84 months ]Titers of ADAs in Arm A.
- Change from Baseline in symptoms as measured by patient-reported outcome version of the common terminology criteria for adverse events (PRO-CTCAE) [ Time Frame: Baseline and up to 84 months ]PRO-CTCAE questionnaire assesses side effect symptoms in cancer clinical trials using a PRO-CTCAE score.
- Change from Baseline in impacts as measured by PRO-CTCAE [ Time Frame: Baseline and up to 84 months ]PRO-CTCAE questionnaire assesses side effect symptoms in cancer clinical trial. Impacts of the side effects will be assessed using PRO-CTCAE score.
- Change from Baseline in health related quality of life (HRQoL) as measured by European Organization for Research and Treatment of Cancer Quality of life Questionnaire 30-item core module (EORTC QLQ-C30) [ Time Frame: Baseline and up to 84 months ]EORTC Quality of Life questionnaire QLQ-C30 on a scale of 0-100. Lower scores correlate with worse quality of life and higher scores correlate with better quality of life.
- Change from Baseline in HRQoL as measured by EORTC item library 52 (IL52) [ Time Frame: Baseline and up to 84 months ]EORTC QLQ- 20-item Multiple Myeloma Module (MY20) questionnaire will be referred to as the EORTC IL52. Only disease symptoms domain will be assessed. A high score represents a high level of symptoms or problems.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Capable of giving signed informed consent.
- Male or female, 18 years or older.
- Have a confirmed diagnosis of multiple myeloma (MM) as defined by the IMWG criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Have been previously treated with at least 1 prior line of MM therapy including a lenalidomide-containing regimen and must have documented disease progression during or after their most recent therapy.
-
Must have at least 1 aspect of measurable disease defined as one of the following;
- Urine M-protein excretion >=200 mg per 24-hour, or
- Serum M-protein concentration >=0.5 grams per deciliter, or
- Serum free light chain (FLC) assay: involved FLC level >=10 mg per deciliter and an abnormal serum free light chain ratio (<0.26 or >1.65) only if participant has no measurable urine or serum M spike.
- Have undergone autologous stem cell transplant (SCT) or are considered transplant ineligible. Participants with a history of autologous SCT may be eligible for study participation.
- All prior treatment-related toxicities (defined by National Cancer Institute Common Toxicity Criteria for Adverse Events [NCI-CTCAE] version 5.0) must be <=Grade 1 at the time of enrolment, except for alopecia.
- Adequate organ system functions.
- Male and female participants agree to abide by protocol-defined contraceptive requirements.
Exclusion Criteria:
- Active plasma cell leukemia, symptomatic amyloidosis or active polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, and skin changes (POEMS) syndrome at the time of screening.
- Prior allogeneic SCT.
- Systemic anti-myeloma therapy (including chemotherapy and systemic steroids) within 14 days or five half-lives (whichever is shorter) preceding the first dose of study drug; prior treatment with a monoclonal antibody drug within 30 days of receiving the first dose of study drugs.
- Plasmapheresis within 7 days prior to the first dose of study drug.
- Received prior treatment with or intolerant to pomalidomide.
- Received prior Beta cell maturation antigen (BCMA) targeted therapy.
- Intolerant to bortezomib or refractory to bortezomib (for example; participant experienced progressive disease during treatment, or within 60 days of completing treatment, with a bortezomib-containing regimen of 1.3 mg/ m^2 twice weekly).
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Evidence of cardiovascular risk including any of the following;
- Evidence of current clinically significant untreated arrhythmias, including clinically significant electrocardiogram abnormalities including second degree (Mobitz type II) or third degree atrioventricular (AV) block.
- Recent history within (3 months of screening) of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting .
- Class III or IV heart failure as defined by the New York Heart Association functional classification system
- Uncontrolled hypertension.
- Any major surgery within the last 4 weeks.
-
Previous or concurrent invasive malignancy other than multiple myeloma, except:
- The disease must be considered medically stable for at least 2 years; or
- The participant must not be receiving active therapy, other than hormonal therapy for this disease.
- Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to belantamab mafodotin or drugs chemically related to belantamab mafodotin, or any of the components of the study treatment.
- Evidence of active mucosal or internal bleeding.
- Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, persistent jaundice.
- Active infection requiring treatment.
- Known human immunodeficiency virus (HIV) infection.
- Presence of hepatitis B surface antigen (HbsAg), or hepatitis B core antibody (HbcAb) at screening or within 3 months prior to first dose of study treatment.
- Positive hepatitis C antibody test result or positive hepatitis ribonucleic acid test result at screening or within 3 months prior to first dose of study treatment.
- Intolerance or contraindications to anti-viral prophylaxis.
- Presence of active renal conditions (such as infection, severe renal impairment requiring dialysis or any other condition that could affect participant's safety).
- Ongoing Grade 2 or higher peripheral neuropathy or neuropathic pain.
- Active or history of venous thromboembolism within the past 3 months.
- Contraindications to or unwilling to undergo protocol-required anti-thrombotic prophylaxis.
- Current corneal disease except for mild punctate keratopathy.
- 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 to the study procedures.
- Pregnant or lactating female.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04484623
Contact: US GSK Clinical Trials Call Center | 877-379-3718 | GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Center | +44 (0) 20 89904466 | GSKClinicalSupportHD@gsk.com |
United States, Colorado | |
GSK Investigational Site | Recruiting |
Denver, Colorado, United States, 80218 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Henning Schade | |
United States, Florida | |
GSK Investigational Site | Recruiting |
Fort Myers, Florida, United States, 33901 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Syed Farhan Zafar | |
GSK Investigational Site | Recruiting |
New Port Richey, Florida, United States, 34655 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Gustaro A Fonseca | |
United States, Missouri | |
GSK Investigational Site | Recruiting |
Kansas City, Missouri, United States, 64132 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Suman Kambhampati | |
United States, Pennsylvania | |
GSK Investigational Site | Recruiting |
Pittsburgh, Pennsylvania, United States, 15224 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Santhosh Sadashiv | |
United States, Tennessee | |
GSK Investigational Site | Recruiting |
Nashville, Tennessee, United States, 37203 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Jesus G Berdeja | |
Australia, Queensland | |
GSK Investigational Site | Recruiting |
South Brisbane, Queensland, Australia, 4101 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Ian Irving | |
Australia, Victoria | |
GSK Investigational Site | Recruiting |
Fitzroy, Victoria, Australia, 3065 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Hang Quach | |
Greece | |
GSK Investigational Site | Recruiting |
Athens, Greece, 10676 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Sosana Delimpasi | |
GSK Investigational Site | Recruiting |
Athens, Greece, 115 28 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Meletios Athanasios Dimopoulos | |
GSK Investigational Site | Recruiting |
Athens, Greece, 11525 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Konstantinos Anargyrou | |
GSK Investigational Site | Recruiting |
Rio/Patras, Greece, 26504 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Argiris S. Symeonidis | |
GSK Investigational Site | Recruiting |
Thessaloniki, Greece, 57010 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Michail Iskas | |
Italy | |
GSK Investigational Site | Recruiting |
Milano, Italy, 20122 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Luca Baldini | |
Korea, Republic of | |
GSK Investigational Site | Recruiting |
Seoul, Korea, Republic of, 03722 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Jin Seok Kim | |
Spain | |
GSK Investigational Site | Recruiting |
Madrid, Navarra, Spain, 28027 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Jesús San Miguel Izquierdo | |
GSK Investigational Site | Recruiting |
Pamplona, Spain, 31008 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Jesús San Miguel Izquierdo | |
GSK Investigational Site | Recruiting |
Sevilla, Spain, 41013 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Estrella Carrillo Cruz |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT04484623 |
Other Study ID Numbers: |
207499 |
First Posted: | July 23, 2020 Key Record Dates |
Last Update Posted: | December 10, 2020 |
Last Verified: | December 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | IPD for this study will be made available via the Clinical Study Data Request site. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) |
Time Frame: | IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study. |
Access Criteria: | Access is provided after a research proposal is submitted and has received approval from the 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 can be granted, when justified, for up to another 12 months. |
URL: | http://clinicalstudydatarequest.com |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Belantamab Mafodotin Relapsed/Refractory Multiple Myeloma Pomalidomide Dexamethasone Bortezomib |
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 Dexamethasone |
Bortezomib Pomalidomide Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Immunologic Factors Angiogenesis Inhibitors |