iCare for Cancer Patients

Multiple Myeloma Clinical Trial

Official title:

iCare for Cancer Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02435550
• Other study ID #: IRB201500073
• Secondary ID: OCR14209
• Status: Terminated
• Phase: N/A
• Start date: June 26, 2015
• Est. completion date: October 1, 2019

Study information

• Verified date: December 2019
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to use genomic information from individual patients to create simulation avatars that will be used to predict novel drug combinations with therapeutic potential.

Description:

As part of normal clinical care, subjects will undergo peripheral blood draws and biopsies for disease assessment of their cancer. In cases of hematological malignancies, bone marrow aspiration & biopsy are routinely performed.

As part of this project, the following will be done to the samples collected and with clinical outcomes data:

• donate peripheral blood specimens whenever blood is already being drawn for clinical purposes.

• donate bone marrow aspiration samples whenever a bone marrow aspiration procedure is already being done for clinical purposes.

• donate saliva whenever blood draw is already being done for clinical purposes.

• allow the investigators to perform gene mutation profiling.

• allow the investigators to study gene mutation results.

• allow the investigators to perform pharmacogenetic profiling.

• allow the investigators to study pharmacogenetic profiles.

• allow the investigators to examine chromosome copy number variations.

• allow the investigators to examine genomic methylation.

• allow the investigators to quantify metabolomics/cytokines.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 136
• Est. completion date: October 1, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Individuals known or suspected of having a blood cancer or hematologic disorder

• Individuals with presence of extramedullary disease

• Capable of providing informed consent.

Exclusion Criteria:

• Does not have a blood cancer or a hematologic disorder

Related Conditions & MeSH terms

• Acute Lymphoid Leukemia
• Acute Myelogenous Leukemia
• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Acute Lymphoblastic
• Leukemia, Lymphoid
• Leukemia, Myeloid, Acute
• Multiple Myeloma
• Myelodysplastic Syndromes
• Myelofibrosis
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Genetic:
• Molecular diagnostic testing
Molecular diagnostic testing will be performed on peripheral blood, bone marrow aspirate and saliva samples that will be collected from each patient as part of routine care. Tests performed may include: cytogenetics, FISH, chromosome copy number variation, next generation DNA sequencing, methylation, and metabolomics.

Locations

Country	Name	City	State
United States	UF Health Shands Cancer Hospital	Gainesville	Florida

Sponsors (3)

Lead Sponsor	Collaborator
University of Florida	Cellworks Group Inc., Gateway for Cancer Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response	The overall response rate (ORR) is defined as achieving a complete remission (CR), partial remission (PR), and/or hematological improvement based on 2006 International Working Group (IWG) criteria (Cheson, et al. Blood 2006).	Up to 5 years
Secondary	Number of patients with drug-related Grade 3 and Grade 4 adverse events	Toxicity will be assessed by the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) v 4. Adverse event incidences will be compared to individual pharmacogenetic gene variants.	Up to 5 years
Secondary	Progression-free survival after treatment	The disease free survival will be analyzed using Kaplan-Meier method and comparisons made to computer predicted response.	Up to five years
Secondary	Overall survival after treatment	The overall survival will be analyzed using Kaplan-Meier method and comparisons made to computer predicted response.	Up to 5 years