Multiple Myeloma Support + Trials

What's the purpose of this trial?

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.

This trial is currently open and accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

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

Additional Trial Information

Enrollment: 1,000 patients (estimated)

Need Help?

Interested in joining or learning more about this trial?

(888) 828-2206

Alabama

Thomas Hospital

Open and Accepting

AIS Cancer Center at San Joaquin Community Hospital

Bakersfield, CA

Open and Accepting

Colorado

Lutheran Hospital - Cancer Centers of Colorado Intermountain Health

Lakewood, CO

Open and Accepting

Delaware

Bayhealth Hospital Kent Campus

Dover, DE

Open and Accepting

Bayhealth Hospital Sussex Campus

Milford, DE

Open and Accepting

Florida

Lynn Cancer Institute Baptist Health Boca Raton Regional Hospital

Open and Accepting

Baton Rouge, LA

Open and Accepting

Children's Hospital New Orleans

New Orleans, LA

Open and Accepting

Open and Accepting

Open and Accepting

Maine Medical Partners Urology MaineHealth

South Portland, ME

Open and Accepting

Open and Accepting

Open and Accepting

Nashua, NH

Open and Accepting

New Jersey

Morristown Medical Center Atlantic Health System

Morristown, NJ

Open and Accepting

Newton Medical Center

Newton, NJ

Open and Accepting

Chilton Medical Center

Pequannock Township, NJ

Open and Accepting

Overlook Hospital

Summit, NJ

Open and Accepting

Greenville, NC

Open and Accepting

Vidant Oncology - Kinston

Kinston, NC

Open and Accepting

FirstHealth Moore Regional Hospital

Open and Accepting

Prisma Health Baptist Hospital

Columbia, SC

Open and Accepting

Gibbs Cancer Center-Gaffney

Gaffney, SC

Open and Accepting

Prisma Health - Greenville Memorial Hospital

Greenville, SC

Open and Accepting

Gibbs Cancer Center-Pelham

Open and Accepting

North Star Lodge Cancer Center

Yakima, WA

Open and Accepting

West Virginia

Edwards Comprehensive Cancer Center

Huntington, WV

Open and Accepting

What's the purpose of this trial?

What will happen during the trial?

You may be able to join this trial if you:

Additional Trial Information

Trial Locations

All Trial Locations

Alabama

Open and Accepting

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Arizona

Open and Accepting

California

Open and Accepting

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Colorado

Open and Accepting

Delaware

Open and Accepting

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Florida

Open and Accepting

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Georgia

Open and Accepting

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Illinois

Open and Accepting

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Iowa

Open and Accepting

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Louisiana

Open and Accepting

Open and Accepting

Maine

Open and Accepting

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Open and Accepting

Temporarily Suspended

Open and Accepting

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Open and Accepting

Michigan

Open and Accepting

Open and Accepting

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Open and Accepting

Missouri

Open and Accepting

Open and Accepting

Open and Accepting

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Open and Accepting

Open and Accepting