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MyelomaPhase 2NCT04680468

Study of Belantamab Mafodotin as Pre- and Post-autologous Stem Cell Transplant and Maintenance for Multiple Myeloma

A Phase 2 study testing Belantamab mafodotin in people with Myeloma, run by University of Pennsylvania at 1 site in United States.

Active, not recruiting

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

Official record
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Trial summary

This is a single-institution, single-arm, phase 2 study in which belantamab mafodotin (GSK2857916), an antibody-drug conjugate targeting B-cell maturation antigen (BCMA), will be administered to patients with multiple myeloma prior to and following high-dose melphalan and autologous stem cell transplantation (ASCT)… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myeloma
What is being tested?
Belantamab mafodotin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
1 siteUnited States
Study dates
2 Jun 2021to 1 Nov 2028
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

  • Must be able to understand the study procedures and have signed written, informed consent.
  • Must be 18 years of age or older at enrollment.
  • Must have started therapy for active multiple myeloma within 12 months of enrollment.
  • Must have an ECOG performance status of 0-2.
  • Have received no more than 2 prior lines of induction therapy (induction regimen not specified by protocol), with no prior progressive disease by International Myeloma Working Group (IMWG) criteria.
  • Must be in at least a partial response (PR) but not in a complete response (CR) or better after at least 4 cycles of induction therapy, per IMWG consensus criteria.
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  • Eligible by institutional criteria to receive melphalan at a dose of 200 mg/m2.
  • Eligible to receive lenalidomide maintenance therapy post-ASCT.
  • Adequate bone marrow and organ function at enrollment.
  • 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 using a contraceptive method that is highly effective (with a failure rate of <1% per year), preferably with low user dependency, during the intervention period and for at least 4 months after the last dose of belantamab mafodotin and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period.
  • Male participants are eligible to participate if they agree to the following during belantamab mafodotin treatment and for 6 months after the last dose of belantamab mafodotin 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 in the protocol.
  • All prior treatment-related toxicities must be grade 1 or less at the time of enrollment except for alopecia.

Who cannot join

  • Must not have used an investigational drug or approved systemic anti-myeloma therapy (including systemic steroids) within 14 days or five half-lives, whichever is shorter, preceding the first dose of study drug.
  • Must not have received treatment with a monoclonal antibody within 28 days of receiving the first dose of study drug
  • Must not be simultaneously enrolled in any interventional clinical trial
  • Must not have amyloidosis or POEMS syndrome.
  • Must not be pregnant or lactating.
  • Must not have current unstable liver or biliary disease defined by the presence of ascites, encephalopathy, coagulopathy, severe hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. Note: Stable non-cirrhotic chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) or hepatobiliary involvement of malignancy is acceptable if otherwise meets entry criteria.
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  • Must not have any evidence of active mucosal or internal bleeding
  • History of an active renal condition (infection, requirement for dialysis or any other condition that could affect subject's safety). Subjects with isolated proteinuria resulting from MM are eligible, provided they fulfill other criteria.
  • Participant must not have evidence of cardiovascular risk, as defined in the protocol.
  • Must not have any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormalities) that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures.
  • Must not have invasive malignancies other than disease under study, unless the second malignancy has been definitively treated or has been medically stable for at least 2 years and, in the opinion of the principal investigator, will not affect the evaluation of the effects of clinical trial treatment.
  • Must not have an active infection requiring antibiotic treatment.
  • Any major surgery within the last 4 weeks prior to enrollment.
  • Must not have current corneal epithelial disease except mild changes in corneal epithelium
  • Must not have known immediate or delayed hypersensitivity reaction or idiosyncratic reactions to belantamab mafodotin or drugs chemically related to belantamab mafodotin, or any of the components of the study treatment
  • Must not have evidence for active hepatitis B infection (i.e. positive hepatitis B surface antigen or nucleic acid-based testing) at screening or within 3 months prior to first dose of belantamab mafodotin.
  • Must not have positive hepatitis C antibody test result or positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study treatment.
  • Must not have evidence of active HIV infection.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Phase 2 Study of Belantamab Mafodotin as Pre- and Post-autologous Stem Cell Transplant Consolidation and Maintenance for Multiple Myeloma

This is a single-institution, single-arm, phase 2 study in which belantamab mafodotin (GSK2857916), an antibody-drug conjugate targeting B-cell maturation antigen (BCMA), will be administered to patients with multiple myeloma prior to and following high-dose melphalan and autologous stem cell transplantation (ASCT), in conjunction with standard lenalidomide maintenance. We hypothesize that administration of belantamab mafodotin as part of autologous stem cell transplant consolidation and maintenance will be safe, well tolerated, and efficacious in comparison to historical data.

Conditions
Myeloma
Being tested
Belantamab mafodotin
Medical subject headings
Neoplasms, Plasma Cell

What participants receive

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

  • Belantamab mafodotinDrug

    Also called GSK2857916

    2.5 mg/kg IV

Study groups in NCT04680468
Study groupRoleWhat they receive
Belantamab mafodotinExperimentalPatients receive Belantamab mafodotin 2.5 mg/kg by intravenous infusion on day -42 relative to autologous stem cell infusion (day 0), on day +60, and every 90 days thereafter, for up to 2 years following ASCT.
Receives: Drug: Belantamab mafodotin

What is being measured

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

  1. MRD (minimal residual disease) negativity rate

    Percentage of participants who have achieved minimal residual disease (MRD) negativity by next-generation sequencing (NGS) at 12 months post-autologous stem cell transplant (ASCT)

    Measured: 12 months post-ASCT

Secondary outcomes (13)

  1. Frequency of treatment-related adverse events

    Percentage of participants who develop adverse and serious adverse events, including ocular adverse events.

    Measured: through study completion, approximately 3 years

  2. Dose reductions

    The percentage of participants who require reduction of the dose of belantamab mafodotin will be assessed

    Measured: through study completion, approximately 3 years

  3. Dose delays

    The percentage of participants who require a delay in dosing of belantamab mafodotin will be assessed

    Measured: through study completion, approximately 3 years

  4. MRD Negativity Rate

    Percentage of participants who have achieved minimal residual disease (MRD) negativity by next-generation sequencing (NGS) at 3 and 24 months post-autologous stem cell transplant (ASCT)

    Measured: at 3 and 24 months post-ASCT

  5. Overall response rate

    Percentage of participants who achieve partial response (PR) or better, as assessed by International Myeloma Working Group (IMWG) criteria.

    Measured: through study completion, approximately 3 years

  6. Very good partial response (VGPR) or better rate

    Percentage of participants who achieve VGPR or better, as assessed by IMWG criteria.

    Measured: through study completion, approximately 3 years

  7. Complete response (CR) or better rate

    Percentage of participants who achieve CR or stringent CR, as assessed by IMWG criteria.

    Measured: through study completion, approximately 3 years

  8. Progression-free survival

    Time from enrollment until progression of disease by IMWG criteria, or death, whichever occurs first

    Measured: through study completion, approximately 3 years

  9. Overall survival

    Time from enrollment until death from any cause

    Measured: through study completion, approximately 3 years

  10. Stem cell yield

    The number of days required to collect sufficient autologous peripheral blood stem cells to proceed to ASCT will be assessed

    Measured: Following stem cell mobilization, about 6 weeks after enrollment

  11. Stem cell collection days

    : The number of days required to collect sufficient autologous peripheral blood stem cells to proceed to ASCT will be assessed

    Measured: Following stem cell mobilization, about 6 weeks after enrollment

  12. Hematopoietic reconstitution post-ASCT

    The number of days until neutrophil and platelet recovery post-ASCT (defined as absolute neutrophil count >1000 cells/mcl and platelet count >50000 cells/mcl, respectively) will be assessed

    Measured: up to 30 days post-ASCT

  13. Change from Baseline in Health-related quality of life (HRQoL) as assessed by Functional Assessment of Cancer Therapy - Multiple Myeloma (FACT-MM) questionnaire

    The FACT-MM questionnaire is a 41 item questionnaire measuring physical, social/family, emotional, and functional well-being, as well as additional concerns

    Measured: baseline through study completion, approximately 3 years.

Timeline

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

  1. First posted23 Dec 2020
  2. Study start2 Jun 2021
  3. Primary completion1 Nov 2026 (estimated)
  4. Study completion1 Nov 2028 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04680468
Sponsor's protocol ID
UPCC 37420
Other IDs
IRB#844252
Status last verified
Oct 2026
First submitted
2 Dec 2020
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Belantamab mafodotin in people with Myeloma, run by University of Pennsylvania at 1 site in United States.

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 16 inclusion and 18 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 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 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?

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?

MRD (minimal residual disease) negativity rate (time frame: 12 months post-ASCT). 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 NCT04680468.

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 14 Oct 2026.

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