Carolinas HealthCare System

Research and Clinical Trials

Multiple Myeloma 

Brief Description PrincipalĀ Investigator
Primary: Provide early access to daratumumab treatment and collect additional
safety data while the medication is not commercially available for subjects with multiple myeloma who have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) or whose disease is double refractory to both a PI and an IMiD.
Usmani, Saad Zafar 
Progression-Free Survival (PFS) Time (Time Frame: From baseline for the duration of disease follow-up, with an expected average of 40 months)
The PFS is defined as time from date of randomization to either progressive disease (PD), or death, whichever occurs first. PD will be determined according to International Myeloma Working Group (IMWG) criteria.
Usmani, Saad Zafar 
To collect high quality specimens from patients with hematologic disorders and normal volunteers.
Future specimen analyses will be performed to determine the differences between sick and normal cells. Data used for these comparisons will include, but are not limited to: gene expression data, DNA, RNA, epigenetics, proteomics, metabolomics, and pathway analysys.
Avalos, Belinda Rene 
Primary: To collect high quality biospecimens to study plasma cell disorders.
Exploratory: 1. To determine the differences between precurser states and multiple myeloma using gene expression data, DNA sequencing, RNA studies, epigenetics, proteomics, metabolomics, pathway analysis, and immunophenotypic analysis. 2. To standardize MRD assays and validate prognostic MRD thesholds for MRD monitoring as a tool for risk-adapted clinical trials. 3. To evaluate biomarkers and immune markers associated
Bhutani, Manisha 
Phase I: To determine appropriate Phase II dose of elotuzumab to use in combination with lenalidomide, bortezomib and dexamethasone for patients with multiple myeloma.
Phase II: To assess whether incorporation of the novel agent elotuzumab into the treatment algorithm of high risk multiple myeloma (HRMM) will improve progression-free survival (PFS). Also, to estimate the frequency and severity of toxicities of this treatment strategy in this patient population.
Usmani, Saad Zafar 
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