Study Summary
This trial is testing a new combination drug treatment for multiple myeloma, a cancer of the blood.
Eligible Conditions
- Relapsed or Refractory Multiple Myeloma
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 4 Secondary · Reporting Duration: From date of randomization until the date of death from any cause, assessed up to 100 months
Day 28
Cytokine Profile Data
Month 100
Overall survival
Progression free survival
Time to progression
Up to 12 weeks
Response rate in Expansion Cohort
Up to 6 weeks
Overall incidence and severity of AEs in Dose Escalation
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Arm A
1 of 2
Arm B
1 of 2
Experimental Treatment
64 Total Participants · 2 Treatment Groups
Primary Treatment: Belantamab Mafodotin, Cyclophosphamide and Dexamethasone · No Placebo Group · Phase 1 & 2
Arm A
Drug
Experimental Group · 1 Intervention: Belantamab Mafodotin, Cyclophosphamide and Dexamethasone · Intervention Types: DrugArm B
Drug
Experimental Group · 1 Intervention: Belantamab Mafodotin, Cyclophosphamide and Dexamethasone · Intervention Types: DrugTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from date of randomization until the date of death from any cause, assessed up to 100 months
Who is running the clinical trial?
University of Maryland, BaltimoreLead Sponsor
618 Previous Clinical Trials
356,734 Total Patients Enrolled
10 Trials studying Multiple Myeloma
114 Patients Enrolled for Multiple Myeloma
Ashraf Badros, MB; ChBPrincipal InvestigatorUniversity of Maryland, Baltimore
Eligibility Criteria
Age 18+ · All Participants · 6 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You may have had a previous stem cell transplant or targeted therapy using CAR-T cells or BiTes, but it must have been more than 100 days ago and any related side effects must have been mild. You should not have any active infections and must meet the inclusion criteria for organ system function. If you are of reproductive age, you should use contraception as required by local regulations.
References
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- Macsai M, Nariani A, Gan H, Lassman A, Merrell R, Gomez E, et al. Corneal Toxicity of ABT-414 in Glioblastoma (GBM): Clinical Manifestations, Ophthalmological Findings and Management. Investigative Ophthalmology & Visual Science. 2016 Sep 26;57(12):269-269.
- Lonial S, Lee HC, Badros A, Trudel S, Nooka AK, Chari A, Abdallah AO, Callander N, Lendvai N, Sborov D, Suvannasankha A, Weisel K, Karlin L, Libby E, Arnulf B, Facon T, Hulin C, Kortum KM, Rodriguez-Otero P, Usmani SZ, Hari P, Baz R, Quach H, Moreau P, Voorhees PM, Gupta I, Hoos A, Zhi E, Baron J, Piontek T, Lewis E, Jewell RC, Dettman EJ, Popat R, Esposti SD, Opalinska J, Richardson P, Cohen AD. Belantamab mafodotin for relapsed or refractory multiple myeloma (DREAMM-2): a two-arm, randomised, open-label, phase 2 study. Lancet Oncol. 2020 Feb;21(2):207-221. doi: 10.1016/S1470-2045(19)30788-0. Epub 2019 Dec 16.
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Frequently Asked Questions
What is the maximum number of participants allowed in this research endeavor?
"Affirmative, based on the information published on clinicaltrials.gov, this research trial is currently recruiting participants. This study was initially posted in early January and recently updated at the end of month. The team intends to enroll 64 individuals from a single location." - Anonymous Online Contributor
Unverified Answer
What is the primary aim of this clinical research?
"This medical trial's primary outcome, which is to be monitored for up to 12 weeks, entails evaluating the overall incidence and intensity of adverse events in a dose escalation experiment. Secondary objectives comprise measuring the time until progression of symptoms, analyzing cytokine profile data (such as IL-4, CXCL10 (IP-10), etc.), and assessing Progression Free Survival - or how long it takes for study drugs to control disease development." - Anonymous Online Contributor
Unverified Answer
Are there any slots available for prospective participants in this clinical trial?
"According to information stored on clinicaltrials.gov, this trial is actively searching for participants with the initial post-date set at January 1st 2022 and latest edit logged as of January 24th 2022." - Anonymous Online Contributor
Unverified Answer
What medical condition is Belantamab Mafodotin, Cyclophosphamide and Dexamethasone commonly prescribed for?
"Belantamab Mafodotin, Cyclophosphamide and Dexamethasone are frequently prescribed to treat synovitis. This potent mix can also be used for ophthalmia, sympathetic pathologies, lung cancers, as well as branch retinal vein occlusion." - Anonymous Online Contributor
Unverified Answer
To what extent has Belantamab Mafodotin, Cyclophosphamide and Dexamethasone been tested as part of other clinical trials?
"Presently, 1293 trials are evaluating Belantamab Mafodotin, Cyclophosphamide and Dexamethasone. Of these studies, 268 are in their concluding phase 3. Despite the majority of research being conducted around Philadelphia Pennsylvania, a total 41370 locations have active clinical trials for this drug combination." - Anonymous Online Contributor
Unverified Answer