Research and Clinical Trials

Brief Description Principal Investigator
To describe the anti-tumor activity (efficacy) and toxicity (safety) of commercially available, targeted anti-cancer drugs used for treatment of patients with advanced solid tumors, multiple myeloma or B cell non-Hodgkin lymphoma with a genomic variant known (i) to be a target of an FDA-approved anti-cancer drug or (ii) to predict sensitivity to an FDA-approved anti-cancer drug. Kim, Edward Sanghyun
Primary: To determine the recommended dose and regimen of durvalumab as monotherapy or
in combination with POM +/- dex in subjects with RRMM.
Secondary:
?h Evaluate the safety and preliminary efficacy of durvalumab monotherapy and in
combination with POM +/- dex in subjects with RRMM
?h Evaluate the pharmacokinetics (PK) of DUR and POM with or without
dexamethasone in subjects with RRMM
Exploratory:
?h Determine the immunogenicity of durvalumab as single agent and when given in
combi
Usmani, Saad Zafar
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 determine the proportion of high risk smoldering multiple myeloma patients who are progression free at 2 years after receiving elotuzumab and lenalidomide +/- dexamethasone combination therapy. (MMRC071) Bhutani, Manisha
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 Objective: The primary objective of the study is to evaluate the safety, tolerability (including dose-limiting toxicity [DLT]), and dosing of daratumumab when administered to subjects with multiple myeloma in combination with various treatment regimens: VELCADE-dexamethasone (VD), VELCADE-melphalan-prednisone (VMP), pomalidomide-dexamethasone (Pom-dex), and VELCADE-thalidomide-dexamethasone (VTD).
Additional Primary Objectives added to Amendment INT-5: The primary objective of the carfi
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
Primary: Compare the Progression Free Survival (PFS) as assessed by CACC blinded central review acccording to the IMWG response critera between treatment arms.
Secondary: Compart eh Overall Survival (OS). Evaluate Overall Response Rate (ORR) and Disease Contraol Rae (DCR) as assessed by CAC blinded central review using IMWG criteria or EBMT criteria for minor response only and DUration of Response (DOR) as assessed by CAC blinded central review using IMWG criteria.
Usmani, Saad Zafar
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
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