National Cancer Institute "Cancer Moonshot Biobank"

Multiple Myeloma Clinical Trial

Official title:

Cancer Moonshot Biobank Research Protocol

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04314401
• Other study ID #: NCI-2020-00750
• Secondary ID: NCI-2020-0075010
• Status: Recruiting
• Start date: November 11, 2020
• Est. completion date: September 16, 2025

Study information

• Verified date: February 2024
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This trial collects multiple tissue and blood samples, along with medical information, from cancer patients. The "Cancer Moonshot Biobank" is a longitudinal study. This means it collects and stores samples and information over time, throughout the course of a patient's cancer treatment. By looking at samples and information collected from the same people over time, researchers hope to better understand how cancer changes over time and over the course of medical treatments.

Description:

PRIMARY OBJECTIVE:

I. To support current and future investigations into drug resistance and sensitivity and other National Cancer Institute (NCI)-sponsored cancer research initiatives through the procurement and distribution of multiple longitudinal biospecimens and associated data from a diverse group of cancer patients who are undergoing standard of care treatment at NCI Community Oncology Research Program (NCORP) sites and other National Clinical Trials Network (NCTN) sites.

SECONDARY OBJECTIVES:

I. To provide a service of value to study participants and their medical providers through the performance of molecular profiling assays on tumor samples in a Clinical Laboratory Improvement Act (CLIA)-certified laboratory and reporting of results to physicians and patients that they may opt to use in clinical management, including analysis of data for acquired resistance mechanisms.

II. To enable the development of patient-derived models such as cell lines and xenografts for cancer researchers through the provision of biospecimens from up to 20% of study participants to the NCI's Patient Derived Models Repository (PDMR), a national resource available to investigators.

III. To develop and implement robust approaches in patient and provider engagement to improve understanding of biobanking and its relationship to cancer research and increase representation of minority and underserved study participants in cancer research.

IV. To develop increased capabilities in United States (U.S.) community hospitals and clinics for contribution to cancer research through biobanking activities.

V. To enable secondary research generated from the project through deposition of data in public repositories such as Cancer Research Data Commons (CRDC), The Cancer Imaging Archive (TCIA) and database of Genotypes and Phenotypes (dbGAP), including clinical, radiology and pathology data with an emphasis on treatment response and outcome data.

VI. To provide residual biospecimens and associated data from the project to the cancer research community.

OUTLINE:

Patients undergo collection of tissue and blood samples prior to initiation of treatment, during treatment, post treatment and at disease progression. Patients with hematological malignancies also undergo collection of bone marrow and cerebral spinal fluid at the same time points. Archival blood and tissue, as well as bone marrow of patients with hematological malignancies, is also collected, if available. Patient medical records are reviewed, and data is collected for at least 5 years.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: September 16, 2025
• Est. primary completion date: September 16, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

Inclusion Criteria:

• Is consistent with OR has been diagnosed with one of the following:

• Colorectal cancer: Stage IV

• Non-small cell or small cell lung cancer: stage III/IV

• Prostate cancer: metastatic prostate cancer

• Gastric cancer, not otherwise specified (NOS): stage IV

• Esophageal cancer, NOS: stage IV

• Adenocarcinoma of gastroesophageal junction: stage IV

• High grade serous ovarian cancer: stage III/IV

• Invasive breast carcinoma: stage III/IV

• Melanoma: stage III/IV

• Acute myeloid leukemia

• Multiple myeloma

• For the purposes of this study, re-staging is allowed

• Patient should fit in one of the following four clinical scenarios (a-d)

• Undergoing diagnostic workup for one of the diseases listed for which treatment will likely include a new regimen of standard of care therapy OR

• Scheduled to begin treatment with a new regimen of standard of care therapy OR

• Currently progressing on a regimen of standard of care therapy OR

• Currently being treated with a regimen standard of care therapy, without evidence of progression

• Requirements for fresh tissue biospecimen collections at enrollment:

• For clinical scenarios a, b, and c above, freshly collected tumor tissue or bone marrow (BM) aspirate must be submitted at enrollment

• For clinical scenarios a and b, the fresh tissue collection must be prior to starting therapy

• For clinical scenario a, the biospecimen collection must be part of a standard of care medical procedure

• For clinical scenarios b or c, the biospecimen collection may be part of a standard of care medical procedure OR

• The biospecimen collection may be part of a study-specific procedure ("research only biopsy"), when the patient has a tumor amenable to image guided or direct vision biopsy and is willing and able to undergo a tumor biopsy for molecular profiling

• Note: For research-only biopsies, the biopsy must not be associated with a significant risk of severe or major complications or death; the procedure cannot be a mediastinal, laparoscopic, open or endoscopic biopsy; nor can the procedure be a brain biopsy; nor can the patient be under the age of majority as determined by each U.S. state

• Requirements for archival tissue:

• For clinical scenarios a and b above, archival tissue as outlined below must be submitted IF AVAILABLE

• For clinical scenarios c and d above, archival tissue as outlined below is REQUIRED

• Pre-existing archival material (formalin-fixed, paraffin-embedded [FFPE] block, BM aspirate, or unstained slides) that:

• Contains the cancer type for which the participant is enrolled, and

• Was collected no more than 5 years prior to initiation of therapy, and

• Contains at least a surface area of 5 mm^2 and optimum surface area of 25 mm^2 or 3-5 mL cryopreserved bone marrow aspirate to yield 200 million bone marrow mononuclear cells, and

• No more than 1 line of standard of care systemic therapy was administered from the date of archival material collection to the date of initiation of therapy

• Requirements for blood collection: ALL scenarios require fresh blood collection at enrollment

• Blood collection for clinical scenarios a, b, and c must take place within 1 week of fresh tumor specimen collection

• Blood collection for clinical scenario d must take place within 4 weeks of enrollment

• Age 13 or older

• Any sex and any gender

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2

• Ability to understand and willingness to sign an informed consent document. Consent may be provided by a Legally Authorized Representative (LAR) in accordance with 45 CFR 46.102(i)

Exclusion Criteria:

• Treated with or has already begun treatment with a non-standard of care therapeutic agent (investigational) in an interventional clinical trial

• Uncontrolled intercurrent illness that in the physician's assessment would pose undue risk for biopsy

• Use of full dose coumarin-derivative anticoagulants such as warfarin are prohibited. Patients may be switched to low molecular weight (LMW) heparin at physician discretion

• Low molecular weight (LMW) heparin is permitted for prophylactic or therapeutic use

• Factor X inhibitors are permitted

• Use of anti-platelet drugs are permitted

• Stopping the anticoagulation treatment for biopsy, bone marrow aspirate, or resection should be per site standard operating procedure (SOP)

• NCI PDMR EXCLUSION CRITERIA: Patients with CRC that is not mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H)

• NCI PDMR EXCLUSION CRITERIA: Patients with complete response

• NCI PDMR EXCLUSION CRITERIA: Patients with invasive fungal infections

• NCI PDMR EXCLUSION CRITERIA: Patients with active and/or uncontrolled infections or who are still recovering from an infection

• Actively febrile patients with uncertain etiology of febrile episode

• All antibiotics for non-prophylactic treatment of infection should be completed at least 1 week (7 days) prior to collection

• No recurrence of fever or other symptoms related to infection for at least 1 week (7 days) following completion of antibiotics

• NCI PDMR EXCLUSION CRITERIA: Patients with human immunodeficiency virus (HIV), active or chronic hepatitis (i.e. quantifiable hepatitis B virus [HBV]-deoxyribonucleic acid [DNA] and/or positive hepatitis B surface antigen [HbsAg], quantifiable hepatitis C virus [HCV]-ribonucleic acid [RNA]) or known history of HBV/HCV without documented resolution

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Adenocarcinoma
• Anatomic Stage III Breast Cancer AJCC v8
• Anatomic Stage IV Breast Cancer AJCC v8
• Breast Neoplasms
• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Carcinoma, Ovarian Epithelial
• Carcinoma, Small Cell
• Clinical Stage III Cutaneous Melanoma AJCC v8
• Clinical Stage IV Cutaneous Melanoma AJCC v8
• Clinical Stage IV Esophageal Adenocarcinoma AJCC v8
• Clinical Stage IV Esophageal Squamous Cell Carcinoma AJCC v8
• Clinical Stage IV Gastric Cancer AJCC v8
• Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
• Esophageal Squamous Cell Carcinoma
• Lung Neoplasms
• Lung Non-Small Cell Carcinoma
• Lung Small Cell Carcinoma
• Malignant Solid Neoplasm
• Melanoma
• Metastatic Prostate Carcinoma
• Multiple Myeloma
• Ovarian Neoplasms
• Prostatic Neoplasms
• Skin Neoplasms
• Small Cell Lung Carcinoma
• Stage III Lung Cancer AJCC v8
• Stage III Ovarian Cancer AJCC v8
• Stage IV Colorectal Cancer AJCC v8
• Stage IV Lung Cancer AJCC v8
• Stage IV Ovarian Cancer AJCC v8
• Stage IV Prostate Cancer AJCC v8
• Stage IVB Prostate Cancer AJCC v8

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of blood, tissue, bone marrow, and cerebral spinal fluid samples

Other:
• Medical Chart Review
Medical charts are reviewed and data is collected

Locations

Country	Name	City	State
Puerto Rico	Centro Comprensivo de Cancer de UPR	San Juan
Puerto Rico	San Juan City Hospital	San Juan
Puerto Rico	San Juan Community Oncology Group	San Juan
United States	McFarland Clinic - Ames	Ames	Iowa
United States	Trinity Health Saint Joseph Mercy Hospital Ann Arbor	Ann Arbor	Michigan
United States	PCR Oncology	Arroyo Grande	California
United States	Northside Hospital	Atlanta	Georgia
United States	Harold Alfond Center for Cancer Care	Augusta	Maine
United States	AIS Cancer Center at San Joaquin Community Hospital	Bakersfield	California
United States	Saint Louis Cancer and Breast Institute-Ballwin	Ballwin	Missouri
United States	Our Lady of the Lake Physician Group	Baton Rouge	Louisiana
United States	Waldo County General Hospital	Belfast	Maine
United States	MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford	Biddeford	Maine
United States	Illinois CancerCare-Bloomington	Bloomington	Illinois
United States	Boca Raton Regional Hospital	Boca Raton	Florida
United States	Trinity Health Medical Center - Brighton	Brighton	Michigan
United States	Children's Hospital at Montefiore	Bronx	New York
United States	Montefiore Medical Center - Moses Campus	Bronx	New York
United States	Montefiore Medical Center-Einstein Campus	Bronx	New York
United States	Montefiore Medical Center-Weiler Hospital	Bronx	New York
United States	MaineHealth Cancer Care - Brunswick	Brunswick	Maine
United States	Mid Coast Hospital	Brunswick	Maine
United States	Trinity Health Medical Center - Canton	Canton	Michigan
United States	Carson Tahoe Regional Medical Center	Carson City	Nevada
United States	Oncology Associates at Mercy Medical Center	Cedar Rapids	Iowa
United States	Physicians' Clinic of Iowa PC	Cedar Rapids	Iowa
United States	Novant Health Presbyterian Medical Center	Charlotte	North Carolina
United States	Chelsea Hospital	Chelsea	Michigan
United States	John H Stroger Jr Hospital of Cook County	Chicago	Illinois
United States	Prisma Health Baptist Hospital	Columbia	South Carolina
United States	Prisma Health Richland Hospital	Columbia	South Carolina
United States	LincolnHealth - Miles Campus and Hospital	Damariscotta	Maine
United States	Carle at The Riverfront	Danville	Illinois
United States	Cancer Care Specialists of Illinois - Decatur	Decatur	Illinois
United States	Decatur Memorial Hospital	Decatur	Illinois
United States	Blank Children's Hospital	Des Moines	Iowa
United States	Iowa Methodist Medical Center	Des Moines	Iowa
United States	Mission Cancer and Blood - Des Moines	Des Moines	Iowa
United States	Bayhealth Hospital Kent Campus	Dover	Delaware
United States	Marshfield Medical Center-EC Cancer Center	Eau Claire	Wisconsin
United States	Thomas Hospital	Fairhope	Alabama
United States	Franklin Memorial Hospital	Farmington	Maine
United States	Mercy Hospital Fort Smith	Fort Smith	Arkansas
United States	Gibbs Cancer Center-Gaffney	Gaffney	South Carolina
United States	Illinois CancerCare-Galesburg	Galesburg	Illinois
United States	Nebraska Cancer Specialists/Oncology Hematology West PC	Grand Island	Nebraska
United States	Corewell Health Grand Rapids Hospitals - Butterworth Hospital	Grand Rapids	Michigan
United States	Prisma Health Greenville Memorial Hospital	Greenville	South Carolina
United States	Gibbs Cancer Center-Pelham	Greer	South Carolina
United States	OptumCare Cancer Care at Seven Hills	Henderson	Nevada
United States	Freeman Health System	Joplin	Missouri
United States	Mercy Hospital Joplin	Joplin	Missouri
United States	Kingman Regional Medical Center	Kingman	Arizona
United States	Alliance for Childhood Diseases/Cure 4 the Kids Foundation	Las Vegas	Nevada
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	Comprehensive Cancer Centers of Nevada - Central Valley	Las Vegas	Nevada
United States	Comprehensive Cancer Centers of Nevada - Town Center	Las Vegas	Nevada
United States	Hope Cancer Care of Nevada	Las Vegas	Nevada
United States	OptumCare Cancer Care at Charleston	Las Vegas	Nevada
United States	OptumCare Cancer Care at Fort Apache	Las Vegas	Nevada
United States	Saint Mary's Regional Medical Center	Lewiston	Maine
United States	Trinity Health Saint Mary Mercy Livonia Hospital	Livonia	Michigan
United States	Centra Alan B Pearson Regional Cancer Center	Lynchburg	Virginia
United States	Marshfield Medical Center-Marshfield	Marshfield	Wisconsin
United States	Carle Physician Group-Mattoon/Charleston	Mattoon	Illinois
United States	Bayhealth Hospital Sussex Campus	Milford	Delaware
United States	Aurora Saint Luke's Medical Center	Milwaukee	Wisconsin
United States	Marshfield Clinic-Minocqua Center	Minocqua	Wisconsin
United States	Mobile Infirmary Medical Center	Mobile	Alabama
United States	Morristown Medical Center	Morristown	New Jersey
United States	Good Samaritan Regional Health Center	Mount Vernon	Illinois
United States	Saint Joseph Hospital	Nashua	New Hampshire
United States	Children's Hospital New Orleans	New Orleans	Louisiana
United States	University Medical Center New Orleans	New Orleans	Louisiana
United States	NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center	New York	New York
United States	Newton Medical Center	Newton	New Jersey
United States	Stephens Memorial Hospital	Norway	Maine
United States	Mercy Hospital Oklahoma City	Oklahoma City	Oklahoma
United States	Illinois CancerCare-Pekin	Pekin	Illinois
United States	Illinois CancerCare-Peoria	Peoria	Illinois
United States	FirstHealth of the Carolinas-Moore Regional Hospital	Pinehurst	North Carolina
United States	Chilton Medical Center	Pompton	New Jersey
United States	Trinity Health Saint Joseph Mercy Oakland Hospital	Pontiac	Michigan
United States	Maine Medical Center-Bramhall Campus	Portland	Maine
United States	Maine Medical Partners Surgical Care	Portland	Maine
United States	MMP Surgical Care Casco Bay	Portland	Maine
United States	Valley Medical Center	Renton	Washington
United States	Marshfield Medical Center-Rice Lake	Rice Lake	Wisconsin
United States	VCU Massey Cancer Center at Stony Point	Richmond	Virginia
United States	Virginia Commonwealth University/Massey Cancer Center	Richmond	Virginia
United States	Penobscot Bay Medical Center	Rockport	Maine
United States	Delbert Day Cancer Institute at PCRMC	Rolla	Missouri
United States	Mercy Clinic-Rolla-Cancer and Hematology	Rolla	Missouri
United States	Heartland Regional Medical Center	Saint Joseph	Missouri
United States	Mercy Hospital Saint Louis	Saint Louis	Missouri
United States	Mercy Hospital South	Saint Louis	Missouri
United States	Missouri Baptist Medical Center	Saint Louis	Missouri
United States	Saint Louis Cancer and Breast Institute-South City	Saint Louis	Missouri
United States	MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford	Sanford	Maine
United States	Lewis Cancer and Research Pavilion at Saint Joseph's/Candler	Savannah	Georgia
United States	Maine Children's Cancer Program	Scarborough	Maine
United States	Maine Medical Center- Scarborough Campus	Scarborough	Maine
United States	Maine Medical Partners Neurology	Scarborough	Maine
United States	LSU Health Sciences Center at Shreveport	Shreveport	Louisiana
United States	Maine Medical Partners - South Portland	South Portland	Maine
United States	Maine Medical Partners Urology	South Portland	Maine
United States	Spartanburg Medical Center	Spartanburg	South Carolina
United States	CoxHealth South Hospital	Springfield	Missouri
United States	Mercy Hospital Springfield	Springfield	Missouri
United States	Marshfield Medical Center-River Region at Stevens Point	Stevens Point	Wisconsin
United States	Overlook Hospital	Summit	New Jersey
United States	Tampa General Hospital	Tampa	Florida
United States	MGC Hematology Oncology-Union	Union	South Carolina
United States	Carle Cancer Center	Urbana	Illinois
United States	Illinois CancerCare - Washington	Washington	Illinois
United States	Mercy Hospital Washington	Washington	Missouri
United States	Marshfield Medical Center - Weston	Weston	Wisconsin
United States	Novant Health Forsyth Medical Center	Winston-Salem	North Carolina
United States	Marshfield Clinic - Wisconsin Rapids Center	Wisconsin Rapids	Wisconsin
United States	North Star Lodge Cancer Center at Yakima Valley Memorial Hospital	Yakima	Washington

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procure, store and distribute longitudinal biospecimens and associated clinical data	Will procure, store and distribute longitudinal biospecimens and associated clinical data for current and future cancer research in order to elucidate molecular mechanisms of sensitivity and intrinsic or acquired resistance to standard of care systemic therapies, including immunotherapy. Cases will be grouped according to patient demographics, cancer type and treatment regimen. Statistical analysis will be descriptive and will be analyzed for each Biospecimen Source Site (BSS) as well as study aggregate.	Up to 10 years
Primary	Percentage of enrolled patients by cancer type and treatment regimen overall	Will assess the percentage of enrolled patients by cancer type and treatment regimen overall and those who contribute samples to the Drug Resistance and Sensitivity Network and other approved investigators. Statistical analysis will be descriptive and will be analyzed for each BSS as well as study aggregate.	Until completion of biospecimen collection, up to 3 years
Primary	Percentage of minority and underserved study participants accrued	Statistical analysis will be descriptive and will be analyzed for each BSS as well as study aggregate.	Until completion of biospecimen collection, up to 3 years
Secondary	Pan-cancer gene panel tumor next generation sequencing test	Statistical analysis will be descriptive and will be analyzed for each BSS as well as study aggregate.	Until completion of biospecimen collection, up to 3 years
Secondary	Cancer Research Data Commons, The Cancer Imaging Archive and database of Genotypes and Phenotypes data contribution	Statistical analysis will be descriptive and will be analyzed for each BSS as well as study aggregate.	Until completion of biospecimen collection, up to 3 years
Secondary	Percentage of minority and underserved study participants accrued	Statistical analysis will be descriptive and will be analyzed for each BSS as well as study aggregate.	Until completion of biospecimen collection, up to 3 years
Secondary	Percentage of enrolled patients for whom molecular profiling is attempted	Statistical analysis will be descriptive and will be analyzed for each BSS as well as study aggregate. Will also be assessed by patient demographics, cancer type and treatment regimen.	Until completion of biospecimen collection, up to 3 years
Secondary	Percentage of enrolled patients for whom molecular profiling results are generated	Statistical analysis will be descriptive and will be analyzed for each BSS as well as study aggregate. Will also be assessed by patient demographics, cancer type and treatment regimen.	Until completion of biospecimen collection, up to 3 years
Secondary	Percentage of enrolled patients for whom samples are obtained at each longitudinal timepoint	Statistical analysis will be descriptive and will be analyzed for each BSS as well as study aggregate. Will also be assessed by patient demographics, cancer type and treatment regimen.	Until completion of biospecimen collection, up to 3 years
Secondary	Percentage of collected biospecimens that are delivered to the Patient Derived Models Repository	Statistical analysis will be descriptive and will be analyzed for each BSS as well as study aggregate. Will also be assessed by patient demographics, cancer type and treatment regimen.	Until completion of biospecimen collection, up to 3 years