Carolinas HealthCare System

Research and Clinical Trials

Multiple Myeloma 

Brief Description PrincipalĀ Investigator
I. To maintain a Childhood Cancer Registry for infants, children, adolescents, and young adults with cancer.

II. To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto Children's Oncology Group (COG) therapeutic clinical trials.

III. To develop a well annotated childhood cancer biobank for current and future research through the collection of biospe
Kaplan, Joel Adam 
Primary: To estimate the response rate after 4 cycles in subjects treated with elotuzumab plus bortezomib, lenalidomide and dexamethseone (E-RVD).
Secondary:
To estimate # of subjects with stem cell mobilization after 4 cycles ERVD.
To estimate # of subjects requiring dose modification of study drug ERVD.
To characterize safety profile of ERVD.
To provide information on activity of ERVD on BR, ORR, PFS
Usmani, Saad Zafar 
To evaluate the pharmacokinetics, safety, and tolerability of SC delivery of daratumumab (Part 1).
To compare the pharmacokinetics, safety, and tolerability of SC and IV delivery of daratumumab (Part 2).
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 
Primary:
To collect high quality specimens from patients with hematologic disorders and normal volunteers.
Exploratory:
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 
To evaluate the efficacy of NEOD001 plus standard of care vs. placebo plus standard of care when administered intravenously in subjects with AL amyloidosis by assessing time to all-cause mortality or cardiac hospitalization. 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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