Belantamab Mafodotin, Pomalidomide and Dexamethasone for the Treatment of High-Risk Myeloma
ConditionPlasma Cell Myeloma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEmory University
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Belantamab Mafodotin
Biological/VaccineGiven IV
Dexamethasone
DrugGiven PO
Pomalidomide
DrugGiven PO
Treatment groups
34 Participants
are divided into 1 treatment groupGroup A: Treatment (belantamab mafodotin, pomalidomide, dexamethasone)Experimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Complete response rate
Assessed per International Myeloma Working Group criteria (best response during maintenance therapy).
Time frame
Up to 3 yearsSecondary outcomes
1
Incidence of adverse events
Toxicities of all patients will be tabulated as frequency and percentage. To evaluate the safety of the belantamab mafodotin, pomalidomide and dexamethasone (BPd) combination in the maintenance setting, proportion of safe patients will be estimated and its 95% confidence interval (CI) will be constructed by assuming binomial distribution. Adverse events will be graded using Common Terminology Criteria for Adverse Events (version 5.0).
Time frame
Up to 3 years2
Very good partial response rate with BPd maintenance
Will be calculated as the proportion with 95% CI, assuming binomial distribution.
Time frame
Up to 3 years3
Stringent complete response rate with BPd maintenance
Will be calculated as the proportion with 95% CI, assuming binomial distribution.
Time frame
Up to 3 years4
Overall response with BPd maintenance
Will be calculated as the proportion with 95% CI, assuming binomial distribution.
Time frame
Up to 3 yearsSponsors and contacts
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Source ClinicalTrials.gov