AzTrials
AzTrials

Multiple MyelomaPhase 2DREAMM-16NCT07614360

Study of Alternative and Approved Dosing Regimens of Belantamab Mafodotin, Bortezomib, and Dexamethasone (BVd) in Participants With Relapsed/Refractory Multiple Myeloma

A Phase 2 study testing Belantamab mafodotin, Dexamethasone and Bortezomib in people with Multiple Myeloma, run by GlaxoSmithKline.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The aim of this study is to assess safety, efficacy and pharmacokinetic (PK) parameters with alternative dosing schedules of belantamab mafodotin in combination with bortezomib and dexamethasone compared to the approved dosing regimen in participants with relapsed or refractory multiple myeloma (RRMM) who have… 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, Dexamethasone and Bortezomib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
No sites listed yet
Study dates
3 Aug 2026to 11 Feb 2031
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Is at least 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the Informed consent form (ICF).
  • Has histologically or cytologically confirmed diagnosis of Multiple myeloma (MM), as defined by the IMWG.
  • Previously treated with at least 2 prior lines of MM therapy, including a proteasome inhibitor and an immunomodulatory agent.
  • Has at least 1 aspect of measurable disease, as assessed by the central laboratory, defined as at least 1 of the following:
  • Urine M-protein excretion >=200 milligrams (mg)/24 hours (>=0.2 grams [g]/24 hours)
  • Serum M-protein concentration >=0.5 grams per deciliter (g/dL) (>=5.0 g/L)
Show all 27Show fewer
  • Serum free light chain (FLC) assay: involved FLC level >=10 milligrams per deciliter (mg/dL) (>=100 mg/L) and an abnormal serum FLC ratio (less than [<] 0.26 or greater than [>] 1.65).
  • Participants with a history of autologous stem cell transplants are eligible for study participation provided the following eligibility criteria are met:
  • Transplant was > 100 days prior to study enrollment
  • No active infection(s)
  • Participant meets the remainder of the eligibility criteria
  • All prior treatment-related toxicities (defined by NCI-CTCAE version [v] 6.0) must be Grade less than or equal to (<=)1 at the time of treatment assignment, except for alopecia (any grade), neuropathy (Grade <=2), or endocrinopathy managed with replacement therapy (any grade).
  • Is willing to use adequate contraception male and female participants. Contraceptive use by male and female participants 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 Treatment Period and for at least 6 months after the last dose of belantamab mafodotin and 5 months after the last dose of bortezomib, whichever is longest, to allow for clearance of any altered sperm:
  • Refrain from donating fresh unwashed semen PLUS either
  • Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), including any activity or passage of ejaculate to another person, and agree to remain abstinent. OR
  • Must agree to use contraception/barrier as detailed below:
  • Agree to use a male condom, even if they have undergone a successful vasectomy, and 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 partner who can become pregnant and is not currently pregnant. Male participants should also use a condom when having sexual intercourse with pregnant females
  • Female participants are eligible to participate if they are not pregnant or breastfeeding, and one of the following conditions applies:
  • Is a Person of non-childbearing potential (PONCBP) OR
  • Is a Person of childbearing potential (POCBP) and using a contraceptive method that is highly effective (with a failure rate of <1% per year), preferably with low user dependency, during the study intervention period and for at 4 months after the last dose of belantamab mafodotin or 8 months after the last dose of bortezomib, whichever is longest, and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of study intervention.
  • A POCBP must have a negative highly sensitive serum pregnancy tests within 72 hours before the first dose of study intervention.
  • The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a person with an early undetected pregnancy.
  • Is capable of giving signed informed consent.
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • Has adequate organ system functions as defined by the laboratory assessments.
  • Participants with a history of Hepatitis B virus (HBV) and/or Hepatitis C virus (HCV) and Human immunodeficiency virus (HIV) exposure are eligible under specific conditions.

Who cannot join

  • Intolerant to bortezomib
  • Diagnosis of systemic amyloid light chain amyloidosis, Waldenstrom's disease, polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, skin changes (POEMS) or Primary Plasma Cell Leukemia (defined as circulating plasma cells >5%)
  • Has previous or concurrent invasive malignancy other than Multiple myeloma (MM), 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.
Show all 36Show fewer
  • Evidence of active mucosal or internal bleeding.
  • Active infection requiring treatment
  • Any major surgery within 4 weeks prior to the first dose of study drug. Exception allowed for bone stabilizing surgery after consultation with Medical Monitor.
  • 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 epithelial 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.
  • Participants after prior allogeneic stem cell transplant.
  • Has received prior belantamab mafodotin therapy.
  • Has received treatment with an investigational agent within 14 days or 5 half-lives, whichever is shorter, preceding the first dose of study drug. This includes prior treatment with a monoclonal antibody and any other B-cell maturation antigen (BCMA) targeting-therapy. The only exception is emergency use of a short course of systemic corticosteroids (equivalent to, or less than: dexamethasone 40 mg/day for a maximum of 4 days) before treatment.
  • Systemic anti-myeloma therapy (including chemotherapy and systemic steroids); prior treatment with an anti-MM monoclonal antibody drug within 30 days of receiving the first dose of study intervention.
  • Plasmapheresis within 7 days prior to the first dose of study treatment. Screening laboratory values must be performed after last plasmapheresis
  • Has received any live vaccine within 30 days of randomization/enrollment. Vaccination against Coronavirus Disease 2019 (COVID-19) using vaccines that are authorized via the appropriate regulatory mechanisms (e.g., Emergency Use Authorization, Conditional Marketing Authorization, or Marketing Authorization Application) are not exclusionary.
  • Is currently enrolled or has participated in any other clinical study involving an investigational drug within 14 days or 5 half-lives (whichever is shorter) preceding the first dose of study intervention.
  • Known Human immunodeficiency virus (HIV) infection, unless the participant can meet all of the following criteria:
  • Established anti-retroviral therapy for at least 4 weeks and HIV viral; load <400 copies/milliliter (mL)
  • Cluster of differentiation 4 (CD4+) T-cell counts >=350 cells/microliter;
  • No history of acquired immune deficiency syndrome (AIDS)-defining opportunistic infections within the last 12 months.
  • Is pregnant, plan to become pregnant, or breastfeeding.
  • Has an Alanine aminotransferase (ALT) value >2.5 times Upper limit of normal (ULN).
  • Has a total bilirubin value >1.5 times ULN
  • Has 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.
  • Has a positive Hepatitis C virus (HCV) antibody test result at screening or within 3 months prior to the first dose of study intervention unless HCV Ribonucleic acid (RNA) is negative, indicating past resolved HCV infection, including participants who have undergone curative treatment.
  • Has a positive HCV RNA test result at screening or within 3 months prior to the first dose of study intervention.
  • Has documented presence of Hepatitis B surface antigen (HBsAg) and/or Hepatitis B virus antibody (HBcAb) at screening or within 3 months prior to the first dose of study intervention unless specific criteria are met.
  • Evidence of cardiovascular risk including any of the following:
  • Evidence of current clinically significant untreated arrhythmias, including clinically significant electrocardiogram (ECG) abnormalities including second degree (Mobitz Type II) or third 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 • Has QT interval corrected (QTc) >450 milliseconds (msec) or QTc >480 msec for participants with bundle branch block.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

US GSK Clinical Trials Call Center contact

877-379-3718

GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center contact

+44 (0) 20 89904466

GSKClinicalSupportHD@gsk.com

About this study

Official title: A Phase 2, Multicenter, Randomized, Open-label Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Alternative and Approved Dosing Regimens of Belantamab Mafodotin in Combination With Bortezomib and Dexamethasone (BVd) in Participants With Relapsed/Refractory Multiple Myeloma

The aim of this study is to assess safety, efficacy and pharmacokinetic (PK) parameters with alternative dosing schedules of belantamab mafodotin in combination with bortezomib and dexamethasone compared to the approved dosing regimen in participants with relapsed or refractory multiple myeloma (RRMM) who have received at least 2 prior lines of therapy. The study will further characterize the risk of ocular toxicity and impact on efficacy measures and PK evaluations using alternative and approved dosing regimens.

Being tested
Belantamab mafodotin, Dexamethasone, Bortezomib
Keywords
Belantamab mafodotin, Bortezomib, Corneal events, Dexamethasone, DREAMM-16, Proteasome inhibitor, Immunomodulatory agent
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

    Belantamab mafodotin will be administered

  • DexamethasoneDrug

    Dexamethasone will be administered.

  • BortezomibDrug

    Bortezomib will be administered

Study groups in NCT07614360
Study groupRoleWhat they receive
Participants receiving Belantamab mafodotin dosing regimen 1 + Bortezomib + DexamethasoneExperimentalParticipants will receive dosing regimen 1 of Belantamab mafodotin in combination with Bortezomib and Dexamethasone
Receives: Drug: Belantamab mafodotin; Drug: Dexamethasone; Drug: Bortezomib
Participants receiving Belantamab mafodotin dosing regimen 2 + Bortezomib + DexamethasoneExperimentalParticipants will receive dosing regimen 2 of Belantamab mafodotin in combination with Bortezomib and Dexamethasone.
Receives: Drug: Belantamab mafodotin; Drug: Dexamethasone; Drug: Bortezomib
Participants receiving Belantamab mafodotin dosing regimen 3 + Bortezomib + DexamethasoneExperimentalParticipants will receive dosing regimen 3 of Belantamab mafodotin in combination with Bortezomib and Dexamethasone.
Receives: Drug: Belantamab mafodotin; Drug: Dexamethasone; Drug: Bortezomib

What is being measured

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

  1. Percentage of participants with grade greater than or equal to (>=)3 corneal events assessed by keratopathy visual acuity (KVA) scale

    KVA scale ranges from 0 to 4 with higher score indicating greater severity of corneal events.

    Measured: Up to approximately 4.5 years

  2. Percentage of participants with grade >=3 corneal events assessed by KVA scale up to Month 6

    KVA scale ranges from 0 to 4 with higher score indicating greater severity of corneal events.

    Measured: Up to Month 6

  3. Percentage of Participants With Grade >=3 Corneal Events Assessed by KVA scale from 6 to 12 months

    KVA scale ranges from 0 to 4 with higher score indicating greater severity of corneal events. Data will be presented for the total number of participants with corneal events in each study group during 6 to 12 months.

    Measured: From 6 to 12 months

Secondary outcomes (18)

  1. Incidence of corneal events as assessed by KVA scale accounting for time on study treatment

    KVA scale ranges from 0 to 4 with higher scores indicating greater severity of corneal events.

    Measured: Up to approximately 4.5 years

  2. Percentage of participants with corneal events as assessed by KVA scale

    KVA scale ranges from 0 to 4 with higher scores indicating greater severity of corneal events.

    Measured: Up to approximately 4.5 years

  3. Number of recurrences of corneal events as assessed by KVA scale

    Number of recurrences of corneal events is defined as the total count of individual corneal event occurrences per participant over the study period. KVA scale ranges from 0 to 4 with higher scores indicating greater severity of corneal events.

    Measured: Up to approximately 4.5 years

  4. Percentage of participants with post-baseline Best corrected visual acuity of 20/50, 20/100, 20/200

    Best corrected visual acuity test results are expressed as a fraction, such as 20/50. The top number is the testing distance of 20 feet, and the bottom number is the distance at which a person with average vision could read the same line. 20/50 indicates mild visual impairment, 20/100 indicates moderate visual impairment and 20/200 indicates severe visual impairment.

    Measured: Up to approximately 4.5 years

  5. Number of participants with ocular adverse events and adverse events of special interest by National Cancer Institute-Common terminology criteria for adverse events (NCI-CTCAE) Version 6.0

    Measured: Up to approximately 4.5 years

  6. Number of participants with adverse events related dose modifications due to ocular toxicity by NCI-CTCAE Version 6.0

    Measured: Up to approximately 4.5 years

  7. Number of participants with adverse events related dose modifications due to ocular toxicity by KVA scale

    KVA scale ranges from 0 to 4 with higher scores indicating greater severity of corneal events.

    Measured: Up to approximately 4.5 years

  8. Overall Response Rate (ORR)

    ORR is defined as the percentage of participants with a confirmed partial response (PR) or better as assessed by the investigator per International Myeloma Working Group (IMWG) criteria.

    Measured: Up to approximately 4.5 years

  9. Percentage of participants with a confirmed Very good partial response (VGPR) or better

    Measured: Up to approximately 4.5 years

  10. Minimal Residual Disease (MRD) Negativity Rate

    MRD negativity rate, defined as the percentage of participants who are MRD-negative by next-generation sequencing (NGS) at 10^-5 sensitivity threshold during the time of confirmed complete response (CR) or better response as assessed by the investigator per IMWG criteria.

    Measured: Up to approximately 4.5 years

  11. Progression-Free Survival (PFS)

    PFS is defined as the time from randomization until the earliest date of documented Progressive disease (PD) as assessed by the investigator per IMWG criteria or death due to any cause.

    Measured: Up to approximately 4.5 years

  12. Number of participants with adverse events by NCI-CTCAE Version 6.0

    Measured: Up to approximately 4.5 years

  13. Number of participants with clinically significant changes in hematology, chemistry, urinalysis parameters

    Measured: Up to approximately 4.5 years

  14. Concentration at end of infusion (C-EOI) following administration of belantamab mafodotin

    Measured: Up to approximately 4.5 years

  15. Area under the plasma concentration-time curve from time 0 to time t (AUC[0-t]) following administration of belantamab mafodotin

    Measured: Up to approximately 4.5 years

  16. Change From Baseline in European Organization for Research and Treatment of Cancer Quality of life questionnaire core 30 (EORTC QLQ-C30) score

    The EORTC QLQ-C30 score ranges from 0 to 100 with higher score indicates better functioning or a better overall state of health.

    Measured: Baseline (Day 1) and up to approximately 4.5 years

  17. Maximum Post-baseline Patient-reported Outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores

    The PRO-CTCAE is a patient-reported outcome measure developed to evaluate symptomatic toxicities in participants in cancer clinical trials and is measured using a scale ranging from 0 to 100. Higher scores indicate poorer side effect experiences.

    Measured: Up to approximately 4.5 years

  18. Mean change from Baseline in vision-related functioning as measured by ocular surface disease index (OSDI)

    The OSDI scores range from 0 to 100. Higher score indicates greater symptom severity.

    Measured: Baseline (Day 1) and up to approximately 4.5 years

Timeline

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

  1. First posted29 May 2026
  2. Study start3 Aug 2026 (estimated)
  3. Primary completion28 Feb 2029 (estimated)
  4. Study completion11 Feb 2031 (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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07614360
Sponsor's protocol ID
300948
Other IDs
2026-526724-43
Acronym
DREAMM-16
Status last verified
Jun 2026
First submitted
21 May 2026
Last updated
24 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Belantamab mafodotin, Dexamethasone and Bortezomib in people with Multiple Myeloma, run by GlaxoSmithKline.

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 27 inclusion and 36 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: opening soon, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants with grade greater than or equal to (>=)3 corneal events assessed by keratopathy visual acuity (KVA) scale (time frame: Up to approximately 4.5 years). The study lists 3 primary outcomes in all. 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 NCT07614360.

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 24 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