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

NCT05208307 | Recruiting Phase 2 DMC FDA Drug

• 4 other identifiers: STUDY00003092NCI-2021-08385Winship5382-21P30CA138292
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Plasma Cell Myeloma

Outcome Measures

Primary Outcomes (1)

• Complete response rate

  Assessed per International Myeloma Working Group criteria (best response during maintenance therapy).

  Up to 3 years

Secondary Outcomes (8)

• Incidence of adverse events

  Up to 3 years

• Very good partial response rate with BPd maintenance

  Up to 3 years

• Stringent complete response rate with BPd maintenance

  Up to 3 years

• Overall response with BPd maintenance

  Up to 3 years

• Progression free survival

  Up to 3 years

Study Arms (1)

Treatment (belantamab mafodotin, pomalidomide, dexamethasone)

EXPERIMENTAL

Patients receive belantamab mafodotin IV over 30 minutes on day 1 of every other cycle, pomalidomide PO QD on days 1-21, and dexamethasone PO QD on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Biological: Belantamab Mafodotin; Drug: Dexamethasone; Drug: Pomalidomide

Interventions

Dexamethasone DRUG

Given PO

Also known as: Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex, Alin, Alin Depot, Alin Oftalmico, Amplidermis, Anemul mono, Auricularum, Auxiloson, Baycadron, Baycuten, Baycuten N, Cortidexason, Cortisumman, Decacort, Decadrol, Decadron, Decadron DP, Decalix, Decameth, Decasone R.p., Dectancyl, Dekacort, Deltafluorene, Deronil, Desamethasone, Desameton, Dexa-Mamallet, Dexa-Rhinosan, Dexa-Scheroson, Dexa-sine, Dexacortal, Dexacortin, Dexafarma, Dexafluorene, Dexalocal, Dexamecortin, Dexameth, Dexamethasone Intensol, Dexamethasonum, Dexamonozon, Dexapos, Dexinoral, Dexone, Dinormon, Dxevo, Fluorodelta, Fortecortin, Gammacorten, Hemady, Hexadecadrol, Hexadrol, Lokalison-F, Loverine, Methylfluorprednisolone, Millicorten, Mymethasone, Orgadrone, Spersadex, TaperDex, Visumetazone, ZoDex

Treatment (belantamab mafodotin, pomalidomide, dexamethasone)

Pomalidomide DRUG

Given PO

Also known as: 4-Aminothalidomide, Actimid, CC-4047, Imnovid, Pomalyst

Treatment (belantamab mafodotin, pomalidomide, dexamethasone)

Belantamab Mafodotin BIOLOGICAL

Given IV

Also known as: Belantamab Mafodotin-blmf, Blenrep, GSK2857916, J6M0-mcMMAF

Treatment (belantamab mafodotin, pomalidomide, dexamethasone)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Emory University: lead
• GlaxoSmithKline: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Emory University/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

belantamab mafodotin; Dexamethasone; Calcium Dobesilate; auricularum; dexamethasone acetate; dexamethasone 21-phosphate; pomalidomide

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Ajay K. Nooka, MD,MPH,FACP

  Emory University/Winship Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ajay K. Nooka, MD,MPH,FACP

CONTACT

(404) 778-1900; anooka@emory.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: January 26, 2022
• Study Start: July 21, 2022
• Primary Completion (Estimated): October 21, 2026
• Study Completion (Estimated): October 21, 2027
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)