Multiple MyelomaPhase 2NCT05789303
Study of Belantamab Mafodotin With Carfilzomib, Pomalidomide, and Dexamethasone in Relapsed Multiple Myeloma
A Phase 2 study testing Belantamab mafodotin, Carfilzomib and Pomalidomide in people with Multiple Myeloma and Relapse Multiple Myeloma, run by University of Chicago at 2 sites in United States.
Trial summary
Doctors leading this study hope to learn if the combination of belantamab mafodotin, carfilzomib, pomalidomide, and dexamethasone is effective and safe when given to people who have multiple myeloma that has gotten worse and is not responding to standard drugs that are used for treating multiple myeloma, including… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Relapse Multiple Myeloma
- What is being tested?
- Belantamab mafodotin, Carfilzomib and Pomalidomide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 May 2023to 1 Jul 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
None listed.
Who cannot join
- Disease Related
- Waldenström's macroglobulinemia, systemic amyloidosis, POEMS syndrome, or plasma cell leukemia at the time of screening.
- Radiotherapy to multiple sites within 3 weeks before start of protocol treatment (localized radiotherapy to a single site 1 week before start is permissible).
- Subject must not have used an investigational drug or approved systemic anti-myeloma therapy (including systemic steroids) within 14 days preceding the first dose of study drug.
- Prior refractory status to belantamab mafodotin. Concurrent Conditions
- Current corneal epithelial disease except mild changes in corneal epithelium and mild punctate keratopathy.
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- Subject must not have current unstable liver or biliary disease defined by the presence of ascites, encephalopathy, coagulopathy, 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.
- Subject must not have presence of active renal condition (infection, requirement for dialysis or any other condition that could affect Subject's safety). Subjects with isolated proteinuria resulting from multiple myeloma (MM) are eligible, provided they fulfil the inclusion criteria.
- Subject must not use contact lenses while participating in this study unless instructed by an ophthalmologist.
- Subject must not be simultaneously enrolled in any interventional clinical trial.
- Subject must not have had major surgery ≤ 2 weeks prior to initiating study treatment.
- Subject must not have any evidence of active mucosal or internal bleeding.
- Significant neuropathy (Grades 3-4, or Grade 2 with pain) at the time of the first dose and/or within 14 days before enrollment.
- Subject must not have evidence of cardiovascular risk including any of the following:
- Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant ECG abnormalities such as 2nd degree (Mobitz Type II) or 3rd degree atrioventricular (AV) block. Controlled atrial fibrillation is not an exclusion.
- History of myocardial infarction, acute coronary syndromes, 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.
- Subject 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.
- Subject must not have an active infection requiring treatment.
- Subject with HIV infection will be excluded unless certain T-cell count, viral load and clinical qualifications are met as confirmed by the study doctor
- Note: consideration must be given to anti-retroviral and prophylactic antimicrobials that may have a drug:drug interaction and/or overlapping toxicities with belantamab mafodotin or other combination products as relevant.
- Patients with Hepatitis B will be excluded unless certain clinical criteria are met as confirmed by the study doctor.
- Subject must not have positive hepatitis C antibody test result or positive hepatitis C Ribonucleic acid test result at screening or within 3 months prior to first dose of study treatment unless the subject can meet the following criteria:
- Hepatitis C Ribonucleic acid test is negative (2) Receives successful anti-viral treatment (typically 8 weeks) followed by a negative nucleocapsid ribonucleic acid test after a washout period of at least 4 weeks.
- Note: Subjects with positive Hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C test is obtained.
- 19. Subject 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. Subjects with curatively treated non-melanoma skin cancer may be enrolled without a 2-year restriction.
- 20. Subject 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.
- 21. Subjects must not be pregnant or lactating.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Eric Hua, 617-975-7414, ehua@bidmc.harvard.edu
Jacalyn Rosenblatt, MD
- Recruiting
University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, 60637
Clinical Trials Intake, 855-702-8222, cancerclinicaltrials@bsd.uchicago.edu
About this study
Official title: Phase II Study of Belantamab Mafodotin in Combination With Carfilzomib, Pomalidomide, and Dexamethasone (KPd) in Patients With Relapsed Multiple Myeloma
Doctors leading this study hope to learn if the combination of belantamab mafodotin, carfilzomib, pomalidomide, and dexamethasone is effective and safe when given to people who have multiple myeloma that has gotten worse and is not responding to standard drugs that are used for treating multiple myeloma, including chimeric antigen receptor T-cell therapy.
Participation in this research will last about 6 -24 months, but it may be less or more depending on your response to treatment.
Read the detailed description
Doctors leading this study hope to learn if the combination of belantamab mafodotin, carfilzomib, pomalidomide, and dexamethasone is effective and safe when given to people who have multiple myeloma that has gotten worse and is not responding to standard drugs that are used for treating multiple myeloma, including chimeric antigen receptor T-cell therapy.
Participation in this research will last about 6 -24 months, but it may be less or more depending on your response to treatment.
The purpose of this research is to gather information on the safety and effectiveness of belantamab mafodotin, carfilzomib, pomalidomide, and dexamethasone for patients with a history of two or more prior lines of myeloma therapy. This combination is not FDA-approved, although carfilzomib and pomalidomide, are separately FDA-approved agents in combination with dexamethasone.
- Conditions
- Multiple Myeloma, Relapse Multiple Myeloma
- Being tested
- Belantamab mafodotin, Carfilzomib, Pomalidomide, Dexamethasone
- Keywords
- multiple myeloma
- 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
Also called Blenrep
Cycles 1, 3, 5, 7, etc. (odd numbered cycles): 1.9 mg/kg IV on Day 1 (28-day cycles)
CarfilzomibDrug
Also called Kyprolis
Cycle 1: 20 mg/m2 on Day 1, then 56 mg/m2 on Days 8/15
Cycles 2-8: 56 mg/m2 on Days 1/8/15
Cycles 9+: 56 mg/m2 on Days 1/15
PomalidomideDrug
Also called Pomalyst
3 mg Day 1-21 of 28-day Cycle
DexamethasoneDrug
Cycles 1-4: 40 mg Days 1/8/15/22
Cycles 5+: 20 mg Days 1/8/15/22
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: No Prior CAR T-Cell Therapy | Experimental | This cohort will consist of 19 participants who have not had CAR T-Cell Therapy. Participants will receive belantamab mafodotin, carfilzomib, pomalidomide and dexamethasone. Receives: Drug: Belantamab mafodotin; Drug: Carfilzomib; Drug: Pomalidomide; Drug: Dexamethasone |
| Cohort 2: Prior CAR T-Cell Therapy | Experimental | This cohort will consist of 64 participants who have had prior CAR T-Cell Therapy. Participants will receive belantamab mafodotin, carfilzomib, pomalidomide and dexamethasone. Receives: Drug: Belantamab mafodotin; Drug: Carfilzomib; Drug: Pomalidomide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Very Good Partial Response (No Prior CAR T-Cell Therapy Cohort)
No prior CAR T-cell therapy cohort: Rate of very good partial response (VGPR) or better after 6 cycles according to the 2016 International Myeloma Working Group (IMWG) Response Criteria by Independent Review Committee (IRC).
Measured: 6-24 months
Rate of Overall Response (Prior CAR T-Cell Therapy Cohort)
Prior CAR T-cell therapy cohort: Rate of overall response (ORR) as determined by investigator assessment.
Measured: 6-24 months
Secondary outcomes (5)
Overall Response Rate
Overall response rate as determined by the 2016 International Myeloma Working Group (IMWG) Response Criteria by Independent Review Committee (IRC) and investigator assessment.
Measured: 6-24 months
Minimal Residual Disease Negativity Rate
Minimal Residual Disease (MRD) negativity rate as assessed by next generation sequencing (limit of detection < 10-5).
Measured: 6-24 months
Progression-Free Survival
Progression-free survival of participants as determined by investigator assessment.
Measured: 6-24 months
Overall Survival Among Participants
Overall survival of participants as determined by investigator assessment.
Measured: 6-24 months
Frequency and Severity of Adverse Events (AEs)/ Serious Adverse Events
Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by the Common Terminology Criteria for Adverse Events v5.
Measured: 6-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start30 May 2023
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
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 University of ChicagoThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline, Amgen
- Responsible party
- Sponsor
- Investigators
- Benjamin Derman, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05789303
- Sponsor's protocol ID
- IRB22-1781
- Status last verified
- Sep 2026
- First submitted
- 23 Mar 2023
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Belantamab Mafodotin in Combination With Carfilzomib, Pomalidomide, and Dexamethasone (KPd) in Patients With Relapsed Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05789303
- Acronym / sponsor ID
- IRB22-1781
- Conditions
- Multiple Myeloma, Relapse Multiple Myeloma
- Keywords
- multiple myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- GlaxoSmithKline, Amgen
- Study start
- 30 May 2023 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 29 Mar 2023 (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.
Doctors leading this study hope to learn if the combination of belantamab mafodotin, carfilzomib, pomalidomide, and dexamethasone is effective and safe when given to people who have multiple myeloma that has gotten worse and is not responding to standard drugs that are used for treating multiple myeloma, including chimeric antigen receptor T-cell therapy.
Participation in this research will last about 6 -24 months, but it may be less or more depending on your response to treatment.
Detailed description
Doctors leading this study hope to learn if the combination of belantamab mafodotin, carfilzomib, pomalidomide, and dexamethasone is effective and safe when given to people who have multiple myeloma that has gotten worse and is not responding to standard drugs that are used for treating multiple myeloma, including chimeric antigen receptor T-cell therapy.
Participation in this research will last about 6 -24 months, but it may be less or more depending on your response to treatment.
The purpose of this research is to gather information on the safety and effectiveness of belantamab mafodotin, carfilzomib, pomalidomide, and dexamethasone for patients with a history of two or more prior lines of myeloma therapy. This combination is not FDA-approved, although carfilzomib and pomalidomide, are separately FDA-approved agents in combination with dexamethasone.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: No Prior CAR T-Cell Therapy | Experimental | Drug: Belantamab mafodotin, Drug: Carfilzomib, Drug: Pomalidomide, Drug: DexamethasoneThis cohort will consist of 19 participants who have not had CAR T-Cell Therapy. Participants will receive belantamab mafodotin, carfilzomib, pomalidomide and dexamethasone. |
| Cohort 2: Prior CAR T-Cell Therapy | Experimental | Drug: Belantamab mafodotin, Drug: Carfilzomib, Drug: Pomalidomide, Drug: DexamethasoneThis cohort will consist of 64 participants who have had prior CAR T-Cell Therapy. Participants will receive belantamab mafodotin, carfilzomib, pomalidomide and dexamethasone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (29 listed)
- Disease Related
- Waldenström's macroglobulinemia, systemic amyloidosis, POEMS syndrome, or plasma cell leukemia at the time of screening.
- Radiotherapy to multiple sites within 3 weeks before start of protocol treatment (localized radiotherapy to a single site 1 week before start is permissible).
- Subject must not have used an investigational drug or approved systemic anti-myeloma therapy (including systemic steroids) within 14 days preceding the first dose of study drug.
- Prior refractory status to belantamab mafodotin. Concurrent Conditions
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 mafodotinAlso: BlenrepCycles 1, 3, 5, 7, etc. (odd numbered cycles): 1.9 mg/kg IV on Day 1 (28-day cycles) | Drug | Cohort 1: No Prior CAR T-Cell Therapy, Cohort 2: Prior CAR T-Cell Therapy |
| CarfilzomibAlso: KyprolisCycle 1: 20 mg/m2 on Day 1, then 56 mg/m2 on Days 8/15 Cycles 2-8: 56 mg/m2 on Days 1/8/15 Cycles 9+: 56 mg/m2 on Days 1/15 | Drug | Cohort 1: No Prior CAR T-Cell Therapy, Cohort 2: Prior CAR T-Cell Therapy |
| PomalidomideAlso: Pomalyst3 mg Day 1-21 of 28-day Cycle | Drug | Cohort 1: No Prior CAR T-Cell Therapy, Cohort 2: Prior CAR T-Cell Therapy |
| DexamethasoneCycles 1-4: 40 mg Days 1/8/15/22 Cycles 5+: 20 mg Days 1/8/15/22 | Drug | Cohort 1: No Prior CAR T-Cell Therapy, Cohort 2: Prior CAR T-Cell Therapy |
Primary outcome
Rate of Very Good Partial Response (No Prior CAR T-Cell Therapy Cohort)
Time frame: 6-24 months
No prior CAR T-cell therapy cohort: Rate of very good partial response (VGPR) or better after 6 cycles according to the 2016 International Myeloma Working Group (IMWG) Response Criteria by Independent Review Committee (IRC).
Rate of Overall Response (Prior CAR T-Cell Therapy Cohort)
Time frame: 6-24 months
Prior CAR T-cell therapy cohort: Rate of overall response (ORR) as determined by investigator assessment.
5 secondary outcomes
Overall Response Rate
Time frame: 6-24 months
Minimal Residual Disease Negativity Rate
Time frame: 6-24 months
Progression-Free Survival
Time frame: 6-24 months
Overall Survival Among Participants
Time frame: 6-24 months
Frequency and Severity of Adverse Events (AEs)/ Serious Adverse Events
Time frame: 6-24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: Yes
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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.
Benjamin Derman, MD principal investigator
University of Chicago
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Belantamab mafodotin, Carfilzomib and Pomalidomide in people with Multiple Myeloma and Relapse Multiple Myeloma, run by University of Chicago at 2 sites 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 0 inclusion and 29 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: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact Clinical Trials Intake (1-855-702-8222, cancerclinicaltrials@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Very Good Partial Response (No Prior CAR T-Cell Therapy Cohort) (time frame: 6-24 months). The study lists 2 primary outcomes in all. 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 23 Sep 2026.