Collect and Assess Tissue Samples From Subjects With Hematologic Malignancy

Multiple Myeloma Clinical Trial

— (ANSWer)  

Official title:

An Observational Study to Collect and Assess Tissue Samples From Subjects With One of Three Neoplastic Conditions (ANSWer)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04014764
• Other study ID #: N-01
• Status: Completed
• Start date: December 15, 2019
• Est. completion date: March 31, 2022

Study information

• Verified date: April 2022
• Source: Notable Labs
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This is a prospective, multicenter observational study to collect clinically annotated biospecimens in order to assess the correlation between ex vivo data generated by the Notable assay platform and clinical outcome.

Description:

This is a prospective, multicenter, observational study with collection of de-identified biospecimens with matched clinical data from up to 1000 participants from clinical networks in the United States and Canada. Clinical information, demographics, and medical data relevant to cancer status are collected from all participants and their medical record at baseline (at study entry and time of baseline biospecimen collection), and subsequent visits per patient consent, for up to 1 year. The primary assessment is the establishment of a tumor registry with annotated clinical outcomes. Exploratory assessments include correlation of ex vivo functional testing results with clinical outcomes, as well as identification of potential biomarkers that correlate responses with genotype and/or phenotype.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Provide written informed consent;
• Age = 18 years, male or female, of any race;
• Documented hematologic malignancy (any of the below) in need of starting an active

anti-cancer therapy:

• Acute myelogenous leukemia (AML)
• Multiple myeloma (MM)
• Myelodysplastic syndrome (MDS)
• Lymphoma
• Acute lymphocytic leukemia (ALL)
• Chronic lymphocytic leukemia (CLL)
• Chronic myelogenous leukemia (CML)
• Neoplasm (MPN)
• Other (upon review and approval by medical monitor) Note: *Supportive care agents including erythropoiesis-stimulating agents (ESAs) such as EPO, Procrit, Aranesp, etc; granulocyte colony stimulating factor (G-CSF); hydroxyurea (Hydrea); and luspatercept (Reblozyl) are not considered anti-cancer therapy for this study
• Intent to start anti-cancer therapy within 21 days of biospecimen collection •=7 days from last anti-cancer therapy;
• Any number of prior therapies
• Subject cohort is currently open

Exclusion Criteria:

• Unwilling or unable to give consent
• Subject's disease is in remission
• Subject cohort is not open at time of consent
• Subject is restarting an ongoing treatment regimen after a dose interruption

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Acute Myelogenous Leukemia
• Chronic Myelogenous Leukemia
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Lymphoma
• Multiple Myeloma
• Myelodysplastic Syndromes
• Myeloproliferative Disorders
• Myeloproliferative Neoplasm
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Other:
• This is a non-interventional study
N/A. This is a non-interventional study. Following consent, the subject will have biospecimen samples taken during routine standard of care procedures, and provided to Sponsor for analysis. Optional research blood draws may occur at treating physician's discretion to obtain additional tissue samples.

Locations

Country	Name	City	State
Greece	University Hospital of Alexandroupolis	Alexandroupolis
Greece	Attikon University Hospital	Athens
Greece	National Kapodistrian Hospital/Laikon General Hospital	Athens
Greece	National Kapodistrian University of Athens	Athens
Greece	University Hospital of Ioánnina	Ioánnina
Greece	University Hospital Patras	Patras
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital San Pedro de Alcántare	Cáceres
Spain	Hospital Universitari I Politècnic La Fe	Valencia
United States	CBCC Global Research	Bakersfield	California
United States	Northern Light Cancer Care Center	Brewer	Maine
United States	The Lindner Center for Research and Education at The Christ Hospital -- The Cancer Center	Cincinnati	Ohio
United States	Colorado West Healthcare System, dba Grand Valley Oncology	Grand Junction	Colorado
United States	East Carolina University	Greenville	North Carolina
United States	Touro Infirmary	New Orleans	Louisiana
United States	Ocala Oncology Center	Ocala	Florida
United States	Mid Florida Hematology and Oncology Center	Orange City	Florida
United States	New York Cancer and Blood Specialists	Port Jefferson Station	New York
United States	Utah Cancer Specialists	Salt Lake City	Utah
United States	Pacific Central Coast Health Centers -- SLO Oncology and Hematology Health Center	San Luis Obispo	California

Sponsors (1)

Lead Sponsor	Collaborator
Notable Labs

Countries where clinical trial is conducted

United States,  Greece,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response to treatment	Collect clinical responses to treatment and outcomes in patients who have provided samples to the biobank	3 years
Secondary	Type of clinical treatment responses	Correlate ex vivo drug sensitivity data on patient samples with clinical treatment responses.	3 years
Secondary	Types of somatic tumor mutations	Determine genotype and/or phenotype relationships between ex vivo and clinical responses with somatic tumor mutations.	3 years

External Links

•   Site Feasibility Questionnaire, public study information