Multiple MyelomaPhase 1NCT05065047
Belantamab Mafadotin Maintenance Therapy After Salvage Autologous Hematopoietic Cell Transplantation in Patients With Relapse Refractory Multiple Myeloma
A Phase 1 study testing Belantamab mafodotin in people with Multiple Myeloma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if belantamab mafodotin (Blenrep) can help to prevent multiple myeloma (MM) from coming back after patients have had an autologous stem cell transplant (AutoSCT). The safety of this drug after transplant will also be studied 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2023to 6 Nov 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Patients with relapsed or refractory multiple myeloma. Eligible patients will be enrolled in the protocol no less than 60 days and must be initiated no longer than 180 days (± 2 weeks) post ASCT. Patient's transplant may be either transplantation naïve or with a history of previous autologous transplant.
- Patients who have had two or more lines of therapy consisting of at least one of three agents including a proteasome inhibitor or an immunomodulatory agent or an anti-CD38 targeting therapy.
- Note:
- Induction therapy, autologous stem cell transplantation (ASCT) \& maintenance therapy if given sequentially without intervening progressive disease (PD) are considered one line of therapy. b) Refractory MM may be defined as disease that is refractory to treatment while on therapy or that shows progression within 60 days of the last therapy.
- Disease status, partial response, or better.
- Age ≥ 18-year and ≤ 75-year. English and non-English speaking patients are eligible.
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- Platelet count ≥ 50,000/mm3 \& Hemoglobin ≥ 8 g/dL, ANC ≥ 1.0 × 109/L
- Karnofsky Performance Status (KPS) >70 (Appendix B.).
- Adequate organ function (ALT ≤ 2.5 ULN; Total bilirubin ≤ 1.5 ULN or total bilirubin
- 1.5 ULN with direct bilirubin ≤ 35%; estimated glomerular filtration rate ≥30 mL/min per 1.73 m2
- Participants must not be pregnant or lactating
- Female participants: contraceptive use should be consistent with institutional guidelines regarding the methods of contraception for those participating in clinical studies.
- 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 (as described in Appendix C.), during the intervention period and for at least 4 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relation to the first dose of the study intervention.
- A WOCBP must have a negative highly sensitive serum pregnancy test (as required by local regulations) within 72 hours before the first dose of the study intervention.
- Nonchildbearing potential is defined as follows (by other than medical reasons):
- ≥45 years of age and has not had menses for >1 year
- Patients who have been amenorrhoeic for <2 years without a history of a hysterectomy and oophorectomy must have a follicle-stimulating hormone value in the postmenopausal range upon screening evaluation
- Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. 10. Male participants: contraceptive use should be consistent with institutional guidelines 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 for 6 months after the last dose of study treatment 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: 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% per year as to when having sexual intercourse with a woman of childbearing potential who is not currently pregnant.
Who cannot join
- 1. Current corneal epithelial disease (except mild punctate keratopathy). 2. Participant must not use contact lenses while participating in this study. 3. Ongoing Grade 2 or higher peripheral neuropathy or neuropathic pain. 4. Participants who are using 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.
- 5. Participants who have current unstable liver or biliary disease defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia (serum albumin < 3.0 gm/dl), 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 6. Participants who have 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 inclusion criteria 7. Participants who have received prior treatment with a monoclonal antibody within 30 days of receiving the first dose of study drugs.
- 8. Participants who have had major surgery ≤ 4 weeks before initiating study treatment.
- 9. Participants who have any evidence of active mucosal or internal bleeding. 10. Participants who 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.
- 11. Participants who have an active infection requiring treatment 12. Participants who have evidence of cardiovascular risk, including any of the following:
- Evidence of current clinically significant uncontrolled and/or untreated arrhythmias, including clinically significant ECG abnormalities such as 2nd degree (Mobitz Type II) or 3rd degree atrioventricular (AV) block.
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- History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within three (3) months of screening.
- Class III or IV heart failure as defined by the New York Heart Association functional classification system.
- Uncontrolled hypertension. 13. Participants who have known HIV infection, 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 14. Participant must not have 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. Note: presence of Hep B surface antibody (HBsAb) indicating previous vaccination will not exclude a participant.
- 15. Participant 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.
- Note: Participants with positive Hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C RNA test is obtained.
- Note: Hepatitis RNA testing is optional and participants with negative Hepatitis C antibody test are not required to also undergo Hepatitis C RNA testing.
- 16. Participant must not have invasive malignancies other than disease under study, unless the second malignancy has been medically stable for at least 2 years and, in the opinion of the principal investigators, will not affect the evaluation of the effects of clinical trial treatments on the currently targeted malignancy. Participants with curatively treated non-melanoma skin cancer may be enrolled without a 2-year restriction.
- 17. Prior allogeneic stem cell transplant. NOTE: Participants who have undergone syngeneic transplant will be allowed only if no history of or no currently active GvHD.
- 18. Symptomatic amyloidosis, active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal plasmaproliferative disorder, skin changes) or active plasma cell leukaemia at the time of screening.
- 19. Patients with cognitive impairments and/or any serious unstable pre-existing medical condition or psychiatric disorder that can interfere with safety or with obtaining informed consent or compliance with study procedures. Informed Consent Process. The informed consent process will begin at recognition of subject eligibility, and consent will be obtained per Institutional practices before study therapy is initiated.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical research study is to learn if belantamab mafodotin (Blenrep) can help to prevent multiple myeloma (MM) from coming back after patients have had an autologous stem cell transplant (AutoSCT). The safety of this drug after transplant will also be studied
Read the detailed description
Primary Objective:
To determine the safety and tolerability of belantamab maintenance therapy after auto-HCT.
Secondary Objectives:
- To estimate the complete remission rate (CRR) as defined by the International Myeloma Working Group (IMWG) criteria (Appendix A.) within 9 months post salvage autotransplant with single agent belantamab mafodotin maintenance therapy starting approximately 3 months post salvage auto-transplant in patients with relapsed myeloma.
- To evaluate progression-free survival (PFS) and overall survival (OS) (from the data of initiation of maintenance therapy assessed up to 2 years)
- To discover the impact of belantamab mafodotin on graft function and immune reconstitution.
- • To assess minimal residual disease status (FDA approved MRD assay by flow cytometry - MRD measured down to 1 in 1 million cells, <106) after at 6 months and 1, 2, and 3 years after initiation of maintenance therapy.
- Conditions
- Multiple Myeloma
- Being tested
- Belantamab mafodotin
- 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
Given by IV
| Study group | Role | What they receive |
|---|---|---|
| Belantamab mafodotin | Experimental | belantamab mafodotin by vein over 30 minutes every 8 weeks Receives: Drug: Belantamab mafodotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0, Change From Baseline in Pain Scores on the Visual Analog Scale at 6 Weeks
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start5 Jan 2023
- Primary completion6 Nov 2025
- Study completion6 Nov 2025
Why it stopped: \<75% participation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neeraj Saini, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05065047
- Sponsor's protocol ID
- 2020-1059
- Other IDs
- NCI-2021-09412
- Status last verified
- Nov 2025
- First submitted
- 25 Aug 2021
- Last updated
- 12 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Belantamab Mafadotin Maintenance Therapy After Salvage Autologous Hematopoietic Cell Transplantation in Patients With Relapse Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05065047
- Acronym / sponsor ID
- 2020-1059
- Conditions
- Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: \<75% participation
- Enrolment
- 6 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 6 Nov 2025 (actual)
- Study completion
- 6 Nov 2025 (actual)
- First posted
- 1 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if belantamab mafodotin (Blenrep) can help to prevent multiple myeloma (MM) from coming back after patients have had an autologous stem cell transplant (AutoSCT). The safety of this drug after transplant will also be studied
Detailed description
Primary Objective:
To determine the safety and tolerability of belantamab maintenance therapy after auto-HCT.
Secondary Objectives:
- To estimate the complete remission rate (CRR) as defined by the International Myeloma Working Group (IMWG) criteria (Appendix A.) within 9 months post salvage autotransplant with single agent belantamab mafodotin maintenance therapy starting approximately 3 months post salvage auto-transplant in patients with relapsed myeloma.
- To evaluate progression-free survival (PFS) and overall survival (OS) (from the data of initiation of maintenance therapy assessed up to 2 years)
- To discover the impact of belantamab mafodotin on graft function and immune reconstitution.
- • To assess minimal residual disease status (FDA approved MRD assay by flow cytometry - MRD measured down to 1 in 1 million cells, <106) after at 6 months and 1, 2, and 3 years after initiation of maintenance therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Belantamab mafodotin | Experimental | Drug: Belantamab mafodotinbelantamab mafodotin by vein over 30 minutes every 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Patients with relapsed or refractory multiple myeloma. Eligible patients will be enrolled in the protocol no less than 60 days and must be initiated no longer than 180 days (± 2 weeks) post ASCT. Patient's transplant may be either transplantation naïve or with a history of previous autologous transplant.
- Patients who have had two or more lines of therapy consisting of at least one of three agents including a proteasome inhibitor or an immunomodulatory agent or an anti-CD38 targeting therapy.
- Disease status, partial response, or better.
- Age ≥ 18-year and ≤ 75-year. English and non-English speaking patients are eligible.
- Platelet count ≥ 50,000/mm3 \& Hemoglobin ≥ 8 g/dL, ANC ≥ 1.0 × 109/L
Key exclusion criteria (19 listed)
- 1. Current corneal epithelial disease (except mild punctate keratopathy). 2. Participant must not use contact lenses while participating in this study. 3. Ongoing Grade 2 or higher peripheral neuropathy or neuropathic pain. 4. Participants who are using 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.
- 5. Participants who have current unstable liver or biliary disease defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia (serum albumin < 3.0 gm/dl), 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 6. Participants who have 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 inclusion criteria 7. Participants who have received prior treatment with a monoclonal antibody within 30 days of receiving the first dose of study drugs.
- 8. Participants who have had major surgery ≤ 4 weeks before initiating study treatment.
- 9. Participants who have any evidence of active mucosal or internal bleeding. 10. Participants who 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.
- 11. Participants who have an active infection requiring treatment 12. Participants who have evidence of cardiovascular risk, including any of the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Belantamab mafodotinGiven by IV | Drug | Belantamab mafodotin |
Primary outcome
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0, Change From Baseline in Pain Scores on the Visual Analog Scale at 6 Weeks
Time frame: through study completion, an average of 1 year
Results and safety
The study was stopped early (reason given: \<75% participation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2025.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neeraj Saini, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Belantamab mafodotin in people with Multiple Myeloma, run by M.D. Anderson Cancer Center 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 26 inclusion and 19 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: stopped early, as of the sponsor's last update on 12 Nov 2025. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: \<75% participation). Results are not available in the source record.
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?
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0, Change From Baseline in Pain Scores on the Visual Analog Scale at 6 Weeks (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2025.