Skip to main content
TTrialFinderData
TrialFinderData is for informational purposes only and does not provide medical advice. Always talk to your doctor.

Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Belantamab Mafodotin, Pomalidomide and Dexamethasone for the Treatment of High-Risk Myeloma

Maintenance Therapy With Belantamab, Pomalidomide and Dexamethasone (BPd) in High-Risk Myeloma Patients: A Phase 2 Study With a Safety Run-In

Belantamab Mafodotin, Pomalidomide and Dexamethasone for the Treatment of High-Risk Myeloma (NCT05208307) is a Phase 2 interventional studying Plasma Cell Myeloma, sponsored by Emory University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This phase II trial studies the effect of belantamab mafodotin, pomalidomide, and dexamethasone in treating patents with high-risk myeloma. Belantamab mafodotin is a monoclonal antibody, called belantamab, linked to a chemotherapy drug, called mafodotin. Belantamab is a form of targeted therapy because it attaches to specific molecules on the surface of cancer cells, known as BCMA receptors, and delivers mafodotin to kill them. Chemotherapy drugs, such as pomalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Anti-inflammatory drugs, such as dexamethasone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Giving belantamab mafodotin, pomalidomide, and dexamethasone may kill more cancer cells.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Plasma Cell Myeloma and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 34 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - Transplant-eligible myeloma patient that has undergone autologous stem cell transplant (ASCT) within one year of their diagnosis and has achieved \>= partial response (PR) based on IMWG standard criteria. Patients will be enrolled within day 60-100 after ASCT - Patient's with high-risk disease defined as - Presence of del(17p); t(4;14); t(14;16); t(14;20) by fluorescence in situ hybridization (FISH) or by cytogenetics (CTG) - Plasma cell leukemia at diagnosis with \>= 20% circulating plasma cells on peripheral blood - Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2 - Participant must be \>= 18 years of age - Absolute neutrophil count (ANC) \>=1.5 x 10\^9/L (performed within 28 days of initiation of protocol therapy unless otherwise specified) - Hemoglobin \>= 8.0 g/dL (performed within 28 days of initiation of protocol therapy unless otherwise specified) - Platelets \>= 75 x 10\^9/L (performed within 28 days of initiation of protocol therapy unless otherwise specified) - Total bilirubin =\< 1.5 x upper limit of normal (ULN) (Isolated bilirubin \>= 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin \< 35%) (performed within 28 days of initiation of protocol therapy unless otherwise specified) - Alanine aminotransferase (ALT) =\< 2.5 x ULN (performed within 28 days of initiation of protocol therapy unless otherwise specified) - Estimated glomerular filtration rate (eGFR) \>= 30 mL/min/ 1.73 m\^2 (performed within 28 days of initiation of protocol therapy unless otherwise specified) - Spot urine (albumin/creatinine ratios) \< 500 mg/g (56 mg/mmol) (performed within 28 days of initiation of protocol therapy unless otherwise specified) ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Transplant-eligible myeloma patient that has undergone autologous stem cell transplant (ASCT) within one year of their diagnosis and has achieved \>= partial response (PR) based on IMWG standard criteria. Patients will be enrolled within day 60-100 after ASCT * Patient's with high-risk disease defined as * Presence of del(17p); t(4;14); t(14;16); t(14;20) by fluorescence in situ hybridization (FISH) or by cytogenetics (CTG) * Plasma cell leukemia at diagnosis with \>= 20% circulating plasma cells on peripheral blood * Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2 * Participant must be \>= 18 years of age * Absolute neutrophil count (ANC) \>=1.5 x 10\^9/L (performed within 28 days of initiation of protocol therapy unless otherwise specified) * Hemoglobin \>= 8.0 g/dL (performed within 28 days of initiation of protocol therapy unless otherwise specified) * Platelets \>= 75 x 10\^9/L (performed within 28 days of initiation of protocol therapy unless otherwise specified) * Total bilirubin =\< 1.5 x upper limit of normal (ULN) (Isolated bilirubin \>= 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin \< 35%) (performed within 28 days of initiation of protocol therapy unless otherwise specified) * Alanine aminotransferase (ALT) =\< 2.5 x ULN (performed within 28 days of initiation of protocol therapy unless otherwise specified) * Estimated glomerular filtration rate (eGFR) \>= 30 mL/min/ 1.73 m\^2 (performed within 28 days of initiation of protocol therapy unless otherwise specified) * Spot urine (albumin/creatinine ratios) \< 500 mg/g (56 mg/mmol) (performed within 28 days of initiation of protocol therapy unless otherwise specified) * Female participants: contraceptive use should be consistent with local regulations 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, 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 the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. WOCBP refers to sexually mature female, regardless of sexual orientation or whether they have undergone tubal ligation, who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally menopausal for at least 24 consecutive months. A WOCBP must have a negative highly sensitive serum pregnancy test (as required by local regulations) 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 woman with a nearly undetected pregnancy. 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 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. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure * Male participants: contraceptive use 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 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 when having sexual intercourse with a woman of childbearing potential (including pregnant females) * All prior treatment-related toxicities (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events \[NCI-CTCAE\], version 4.03) must be =\< grade 1 at the time of enrolment except for alopecia * Participant must be able to understand the study procedures and agree to participate in the study by providing written informed consent Exclusion Criteria: * Participant must not have current corneal epithelial disease except mild changes in corneal epithelium * Participant 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 * Participant must not 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 multiple myeloma (MM) are eligible, provided they fulfil inclusion criteria * Participant must not use contact lenses while participating in this study * Participant must not be simultaneously enrolled in any interventional clinical trial * Participant 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 * Participant must not have had plasmapheresis within 7 days prior to first dose of study treatment * Participant must not have received prior treatment with a monoclonal antibody within 30 days of receiving the first dose of study drugs * Participant must not have had major surgery =\< 4 weeks prior to initiating study treatment * Participant must not have any evidence of active mucosal or internal bleeding * Participant must not have evidence of cardiovascular risk including any of the following: * Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant electrocardiogram (ECG) abnormalities such as 2nd degree (Mobitz Type II) or 3rd degree atrioventricular (AV) block * 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 (NYHA, 1994) * Uncontrolled hypertension * Participant 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 * Participant must not have an active infection requiring treatment * Known human immunodeficiency virus (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 acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within the last 12 months * Note: consideration must be given to antiretroviral therapy (ART) and prophylactic antimicrobials that may have a drug:drug interaction and/or overlapping toxicities with belantamab mafodotin or other combination products as relevant * Positive hepatitis C antibody test result or positive hepatitis C ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study treatment unless the participant can meet the following criteria: * RNA test negative * Successful anti-viral treatment (usually 8 weeks duration) is required, followed by a negative hepatitis C virus (HCV) RNA test after a washout period of at least 4 weeks * Patients will hepatitis B will be excluded unless the following criteria can be met * SEROLOGY: Hepatitis B core antibody positive (HbcAb+), hepatitis B surface antigen negative (HbsAg-); SCREENING: Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) undetectable; DURING STUDY TREATMENT: Monitoring per protocol, antiviral treatment instituted if HBV DNA becomes detectable * SEROLOGY: HBsAg+ at screen or within 3 months prior to first dose; SCREENING: HBV DNA undetectable, highly effective antiviral treatment started at least 4 weeks prior to first dose of study treatment, baseline imaging per protocol, participants with cirrhosis are excluded; DURING STUDY TREATMENT: Antiviral treatment maintained throughout study treatment, monitoring and management per protocol * Note: presence of hep B surface antibody (HBsAb) indicating previous vaccination will not exclude a participant * 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 * Participant must not have any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormalities) that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures * Diagnosed with smoldering MM, monoclonal gammopathy of undetermined significance, Waldenstrom's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome, amyloidosis or standard risk myeloma or secondary plasma cell leukemia * High risk patients that did not achieve \>= PR after stem cell transplant * Participant has \>= grade 2 peripheral neuropathy on clinical examination within 28 days before initiation of protocol therapy * Participants must not be pregnant or lactating * Any condition, including laboratory abnormalities, that in the opinion of the investigator places the subject at unacceptable risk if he/she were to participate in the study * Prior malignancy (within the last 5 years) except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer * Known hypersensitivity to acyclovir or similar anti-viral drug * Known intolerance to steroid therapy * Contraindication or prior intolerance to thromboembolic prophylaxis with aspirin, warfarin or low-molecular weight heparin * Participants with known central nervous system (CNS) disease * Poor tolerability or known allergy to any of the study drugs or compounds of similar chemical or biologic composition to dexamethasone, boron or mannitol

Treatments Being Tested

BIOLOGICAL

Belantamab Mafodotin

Given IV

DRUG

Dexamethasone

Given PO

DRUG

Pomalidomide

Given PO

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Emory University/Winship Cancer Institute
Atlanta, Georgia, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05208307), the sponsor (Emory University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05208307 clinical trial studying?

This phase II trial studies the effect of belantamab mafodotin, pomalidomide, and dexamethasone in treating patents with high-risk myeloma. Belantamab mafodotin is a monoclonal antibody, called belantamab, linked to a chemotherapy drug, called mafodotin. Belantamab is a form of targeted therapy because it attaches to specific molecules on the surface of cancer cells, known as BCMA receptors, and delivers mafodotin to kill them. Chemotherapy drugs, such as pomalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by … The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05208307?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05208307?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05208307. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05208307. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.