AzTrials
AzTrials

Multiple MyelomaPhase 3DREAMM 8NCT06956170

All Japanese Population: Belantamab Mafodotin Plus Pomalidomide and Dexamethasone (Pd) Versus Bortezomib Plus Pd in Relapsed/Refractory Multiple Myeloma

A Phase 3 study testing Belantamab mafodotin, Pomalidomide and Dexamethasone in people with Multiple Myeloma, run by GlaxoSmithKline at 13 sites in Japan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This study will evaluate the efficacy and safety of belantamab mafodotin in combination with pomalidomide and dexamethasone compared with that of combination of pomalidomide, bortezomib and dexamethasone in Japanese participants with relapsed/refractory multiple myeloma (RRMM). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Belantamab mafodotin, Pomalidomide and Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
13 sitesJapan
Study dates
10 Feb 2022to 25 Jun 2029
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 International Myeloma Working Group (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. (Participants treated with lenalidomide ≥10 mg daily for at least 2 consecutive cycles are eligible).
  • Must have at least 1 aspect of measurable disease defined as one of the following;
Show all 14Show fewer
  • Urine M-protein excretion greater than or equal to (≥)200 milligrams (mg) per 24-hour, or
  • Serum M-protein concentration ≥0.5 grams/deciliters (g/dL) (≥5.0 g/liter [L]), or
  • Serum free light chain (FLC) assay: involved FLC level ≥10 mg/dL (≥100 mg/L) and an abnormal serum free light chain ratio (less than [<]0.26 or greater than [>]1.65) only if participant has no measurable urine or serum M spike.
  • Have undergone autologous stem cell transplant (ASCT) or are considered transplant ineligible. Participants with a history of ASCT are eligible for study participation provided the following eligibility criteria are met: a. ASCT was >100 days prior to the first dose of study medication. b. No active bacterial, viral, or fungal infection(s) present
  • All prior treatment-related toxicities (defined by National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE] version 5.0) must be less than or equal to (≤)Grade 1 at the time of enrolment, except for alopecia.
  • Adequate organ system functions as mentioned in the protocol.
  • Male and female participants agree to abide by protocol-defined contraceptive requirements.
  • In Japan, Hepatitis B participants who are hepatitis B surface antigen (HbsAg)- (e.g. HBsAb+/HbsAg-, HBcAb+/HbsAg-, HBcAb+/HBsAb+/HbsAg-) are eligible for inclusion in this study if hepatitis B virus (HBV) DNA is undetectable. A patient with HBsAg+ is eligible if HBV DNA is undetectable after assessing hepatitis B e antigen (HBeAg), hepatitis B e antibody (HBeAb) and HBV DNA, and if a hepatologist agrees with the participation into this study.

Who cannot join

  • 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.
Show all 28Show fewer
  • 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/meter square [m^2] twice weekly).
  • 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 (NYHA) 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, hypoalbuminemia, esophageal or gastric varices, persistent jaundice.
  • Active infection requiring treatment.
  • Known or active human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C will be excluded unless the protocol-defined criteria are met.
  • 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 peripheral neuropathy with pain within 14 days prior to randomization or ≥Grade 3 peripheral neuropathy.
  • Active or history of venous and arterial 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 laboratory abnormalities) that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures.
  • Pregnant or lactating female.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Japan13 sites

  • GSK Investigation Site

    Fukushima, Fukushima, 960-1295

  • GSK Investigational Site

    Hokkaido, 060-8648

  • GSK Investigational Site

    Kamogawa, Chiba, 296-8602

  • GSK Investigational Site

    Kashiwa, Chiba, 277-8567

  • GSK Investigational Site

    Maebashi, Gunma, 371-8511

  • GSK Investigational Site

    Matsuyama, Ehime, 790-8524

  • GSK Investigational Site

    Nagoya, Aichi-ken, 467-8602

  • GSK Investigational Site

    Numakunai, Iwate, 028-3695

  • GSK Investigational Site

    Okayama, Okayama-ken, 701-1192

  • GSK Investigational Site

    Osaka, Osaka, 565-0871

  • GSK Investigational Site

    Shibukawa, Gunma, 377-0280

  • GSK Investigational Site

    Tottori-shi, Tottori, 683-8504

  • GSK Investigational Site

    Yamagata, Yamagata, 990-9585

Other trials in Japan

About this study

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)

This study will evaluate the efficacy and safety of belantamab mafodotin in combination with pomalidomide and dexamethasone compared with that of combination of pomalidomide, bortezomib and dexamethasone in Japanese participants with relapsed/refractory multiple myeloma (RRMM).

Being tested
Belantamab mafodotin, Pomalidomide, Dexamethasone, Bortezomib
Keywords
Japan population, Belantamab Mafodotin, Relapsed/Refractory Multiple Myeloma, Pomalidomide, Dexamethasone, Bortezomib
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Belantamab mafodotinDrug

    Humanized anti-B-cell maturation antigen (BCMA) antibody/drug conjugate will be administered.

  • PomalidomideDrug

    Immunomodulatory drug (IMiD) will be administered.

  • DexamethasoneDrug

    Synthetic glucocorticoid with anti-tumor activity will be administered.

  • BortezomibDrug

    Proteasome Inhibitor will be administered.

Study groups in NCT06956170
Study groupRoleWhat they receive
Belantamab mafodotin plus Pomalidomide and DexamethasoneExperimentalNot described
Receives: Drug: Belantamab mafodotin; Drug: Pomalidomide; Drug: Dexamethasone
Bortezomib plus Pomalidomide and DexamethasoneActive comparatorNot described
Receives: Drug: Pomalidomide; Drug: Dexamethasone; Drug: Bortezomib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (PFS)

    PFS is defined as time from randomization until earliest date of disease progression (PD), determined by Independent Review Committee (IRC), according to the International Myeloma Working Group (IMWG) Response Criteria, or death due to any cause. PD is defined as increase of >=25% from lowest value in >=1 of following (serum M-protein [absolute increase >=0.5 grams per deciliter {g/dL}]; serum M-protein increase >=1g/dL [when lowest M-protein >=5g/dL]; urine M-protein [absolute increase >=200 milligrams per 24 hours {mg/24h}]; participants without measurable serum \& urine M-protein levels, difference between involved \& uninvolved serum free light chains (sFLC) levels [absolute increase >10mg/dL]; appearance of new lesion,>=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 longest diameter of previous lesion >1 centimeter (cm) in short axis.

    Measured: Up to approximately 120 weeks

Secondary outcomes (28)

  1. Overall Survival (OS)

    Overall Survival (OS) defined as the interval of time from randomization to the date of death due to any cause.

    Measured: Up to approximately 407 weeks

  2. Duration of Response (DoR)

    Duration of Response (DoR) defined as the time from first documented evidence of partial response (PR) or better until progressive disease (PD) or death due to any cause. Response will be based on IRC-assessment per IMWG criteria.

    Measured: Up to approximately 407 weeks

  3. Minimal Residual Disease (MRD) Negativity Rate

    MRD negativity rate defined as the percentage of participants who achieve MRD negative status (as assessed by NGS at 10^5 threshold) at least once during the time of confirmed CR or better response based on IRC-assessment per IMWG.

    Measured: Up to approximately 407 weeks

  4. Overall Response Rate (ORR)

    ORR is defined as the percentage of participants with a confirmed partial response or better (i.e., PR, VGPR, CR, and sCR) based on IRC-assessment per IMWG criteria.

    Measured: Up to approximately 407 weeks

  5. Complete Response Rate (CRR)

    Complete Response Rate (CRR), defined as the percentage of participants with a confirmed complete response (CR) or better (i.e., CR and stringent complete response (sCR)) based on IRC assessment per IMWG criteria.

    Measured: Up to approximately 407 weeks

  6. Percentage of Participants With a Confirmed Very Good Partial Response (VGPR) or Better

    VGPR is defined as the percentage of participants with a confirmed VGPR or better (i.e., VGPR, CR, and sCR) based on IRC-assessment per IMWG criteria.

    Measured: Up to approximately 407 weeks

  7. Time to Best Response (TTBR)

    Time to Best Response (TTBR) defined as the interval of time between the date of randomization and the earliest date of achieving best response among participants with a confirmed PR or better based on IRC-assessment per IMWG.

    Measured: Up to approximately 407 weeks

  8. Time to Response (TTR)

    Time to Response (TTR) defined as the time between the date of randomization and the first documented evidence of response (PR or better) among participants who achieve a response (i.e., confirmed PR or better) based on IRC-assessment per IMWG.

    Measured: Up to approximately 407 weeks

  9. Time to Progression (TTP)

    Time to Progression (TTP) defined as the time from randomization until the earliest date of PD based on IRC-assessment per IMWG criteria, or death due to PD.

    Measured: Up to approximately 407 weeks

  10. Progression-free Survival on Subsequent Line of Therapy (PFS2)

    PFS2 defined as time from randomization to disease progression (investigator-assessed response) after initiation of new anti-myeloma therapy or death from any cause, whichever is earlier. If disease progression after new antimyeloma therapy cannot be measured, a PFS event is defined as the date of discontinuation of new anti-myeloma therapy, or death from any cause, whichever is earlier.

    Measured: Up to approximately 407 weeks

  11. Number of Participants With Adverse Events (AEs)

    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. AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA dictionary).

    Measured: Up to approximately 407 weeks

  12. Number of Participants With Clinically Significant Changes in Hematology Parameters

    Blood samples will be collected for the analysis of hematology parameters.

    Measured: Up to approximately 407 weeks

  13. Number of Participants With Clinically Significant Changes in Clinical Chemistry Parameters

    Blood samples will be collected for the analysis of clinical chemistry parameters.

    Measured: Up to approximately 407 weeks

  14. Number of Participants With Abnormal Ocular Findings on Ophthalmic Examination

    Measured: Up to approximately 407 weeks

  15. Plasma Concentrations of Belantamab Mafodotin (ADC)

    Blood samples will be collected for PK analysis of belantamab mafodotin.

    Measured: Up to approximately 407 weeks

  16. Plasma Concentrations of Monomethyl Auristatin-F With a Cysteine Linker (Cys-mcMMAF)

    Blood samples will be collected for PK analysis of belantamab mafodotin.

    Measured: Up to approximately 407 weeks

  17. Area Under Plasma Concentration-time Curve (AUC) From Time 0 to the Time of the Last Quantifiable Concentration (C(Tlast)) [AUC (0-last)] for Pomalidomide

    Blood samples will be collected for PK analysis of Pomalidomide in combination with belantamab mafodotin and dexamethasone

    Measured: Up to approximately 407 weeks

  18. Area Under Plasma Concentration-time Curve (AUC) From Time 0 to End of the Dosing Interval [AUC (0-tau)] for Pomalidomide

    Blood samples will be collected for PK analysis of Pomalidomide in combination with belantamab mafodotin and dexamethasone.

    Measured: Up to approximately 407 weeks

  19. Maximum Concentration (Cmax) for Pomalidomide

    Blood samples will be collected for PK analysis of Pomalidomide in combination with belantamab mafodotin and dexamethasone.

    Measured: Up to approximately 407 weeks

  20. Time of Cmax (Tmax) for Pomalidomide

    Blood samples will be collected for PK analysis of Pomalidomide in combination with belantamab mafodotin and dexamethasone.

    Measured: Up to approximately 407 weeks

  21. Trough Concentration Prior to the Next Dose for Each Cycle (Ctrough) for Pomalidomide

    Blood samples will be collected for PK analysis of Pomalidomide in combination with belantamab mafodotin and dexamethasone.

    Measured: Up to approximately 407 weeks

  22. Last Time Point Where the Concentration is Above the Limit of Quantification (Tlast) for Pomalidomide

    Blood samples will be collected for PK analysis of Pomalidomide in combination with belantamab mafodotin and dexamethasone.

    Measured: Up to approximately 407 weeks

  23. Number of Participants With Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin

    Serum samples will be collected for the analysis of the presence of ADAs using validated immunoassays. All samples will be tested in screening assay, and positive samples will be further characterized for antibody titers.

    Measured: Up to approximately 407 weeks

  24. Titers of ADAs Against Belantamab Mafodotin

    Serum samples will be collected for the analysis of the presence of ADAs using validated immunoassays. All samples will be further tested in screening assay, and positive samples will be further characterized for antibody titers.

    Measured: Up to approximately 407 weeks

  25. Number of Participants With Maximum Post-baseline Changes in Patient-reported Outcome Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores for Each Item Attribute

    The PRO-CTCAE is a patient-reported outcome measure that was developed to evaluate symptomatic toxicities in patients in cancer clinical trials; it characterizes the frequency, severity, interference, and presence or absence of symptomatic toxicities. Responses ranges from 0 ("never," "none," "not at all," or "absent") to 4 ("almost constantly," "very severe," or "very much"), with a higher score indicating a higher frequency, severity, or interference of adverse events.

    Measured: Up to approximately 407 weeks

  26. 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)

    The EORTC QLQ-C30 includes 30-items with single and multi-item scales. These includes five functional scales (physical functioning [PF], role functioning [RF], cognitive functioning [CF], emotional functioning [EF] and social functioning [SF]), three symptom scales (fatigue, pain and nausea/vomiting [N/V]), a global health status (GHS)/ Quality-of-Life (QoL) scale, and six single items (constipation, diarrhoea, insomnia, dyspnoea, appetite loss [AL] and financial difficulties [FD]). Response options are 1 to 4. Scores are averaged and transformed to 0 to 100, a high score for functional scales/ GHS/QoL represent better functioning ability or health-related quality-of-life (HRQoL), whereas a high score for symptom scales/ single items represent significant symptomatology. Baseline is defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Change from Baseline is calculated by subtracting Baseline value from the post-dose visit value.

    Measured: Baseline and up to approximately 407 weeks

  27. Change From Baseline in HRQoL as Measured by EORTC QLQ-20-item Multiple Myeloma Module (MY20)

    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. The individual component scores in the disease symptom domain are averaged and transformed linearly to a score ranging from 0 to 100. A high score for disease symptoms represents a high level of symptomatology or problems. A high score for Future Perspective and Body Image represents a high/healthy level of functioning. Baseline is defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Change from Baseline is calculated by subtracting Baseline value from the post-dose visit value.

    Measured: Baseline and up to approximately 407 weeks

  28. Change From Baseline in HRQoL as Measured by EORTC Item Library 52 (IL52)

    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 to 100. A high score for disease symptoms represents a high level of symptomatology or problems. Baseline is defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Change from Baseline is calculated by subtracting Baseline value from the post-dose visit value.

    Measured: Baseline and up to approximately 407 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2025
  2. Study start10 Feb 2022
  3. Primary completion27 May 2024
  4. Study completion25 Jun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06956170
Sponsor's protocol ID
207499-JPN
Acronym
DREAMM 8
Status last verified
May 2026
First submitted
25 Apr 2025
Last updated
12 Jun 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Belantamab mafodotin, Pomalidomide and Dexamethasone in people with Multiple Myeloma, run by GlaxoSmithKline at 13 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (time frame: Up to approximately 120 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06956170.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in