A Multicenter Prospective Observational Cohort Study Evaluating the Impact of Cancer-Directed Treatment and Medication Use, Including Cannabis Use, in Multiple Myeloma Patients
NCT ID: NCT07225738
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
700 participants
OBSERVATIONAL
2025-12-24
2027-05-13
Brief Summary
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Detailed Description
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I. Characterize and compare longitudinal patterns in quality of life, as assessed by the Functional Assessment of Cancer Therapy-Multiple Myeloma (FACT-MM) instrument, among cannabis users and non-users.
II. Estimate and characterize the potential therapeutic benefit and adverse effects associated with cannabis use as assessed by longitudinal patterns of patient reported symptoms (Edmonton Symptoms Assessment Scale-ESAS) and medical assessments (Common Terminology Criteria for Adverse Events-CTCAE v5.0) through a comparative analysis of users and non-users.
OUTLINE: This is an observational study. Participants are assigned to 1 of 2 groups.
GROUP I: Patients complete surveys and undergo blood sample collection throughout the study.
GROUP II: Healthcare providers complete a survey on study.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Observational group I
Patients complete surveys and undergo blood sample collection throughout the study.
Non-Interventional Study
Non-interventional study
Observational group II
Healthcare providers complete a survey on study.
Non-Interventional Study
Non-interventional study
Interventions
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Non-Interventional Study
Non-interventional study
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age: ≥ 18 years
* ECOG ≤ 3
* Ability to read and understand English
* Patient must be newly diagnosed with a histologically confirmed multiple myeloma
* Patients may have started first line therapies and received up to four cycles
* HCP SURVEY: Documented informed consent of the participant
* HCP SURVEY: Age: ≥ 18 years
* HCP SURVEY: Licensed physician, physician assistant, nurse practitioner, or registered nurse
* HCP SURVEY: Currently practicing in oncology or providing direct care to oncology patients
* HCP SURVEY: Able to read and understand English
* HCP SURVEY: Affiliation with City of Hope
Exclusion Criteria
* Other active malignancy
* Patients may not have undergone autologous hematopoietic stem cell transplantation
* Unable to comply with the study assessments
* HCP SURVEY: Reports directly to study PI (Dr. Richard Lee)
* HCP SURVEY: Member of the study team or involved in survey design or analysis
* HCP SURVEY: Individuals with a real or perceived conflict of interest that could bias survey responses
18 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Richard T Lee
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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CTCA at Western Regional Medical Center
Goodyear, Arizona, United States
City of Hope Medical Center
Duarte, California, United States
City of Hope Seacliff
Huntington Beach, California, United States
City of Hope at Irvine Lennar
Irvine, California, United States
City of Hope at Long Beach Elm
Long Beach, California, United States
City of Hope at Newport Beach Fashion Island
Newport Beach, California, United States
City of Hope South Pasadena
South Pasadena, California, United States
City of Hope Upland
Upland, California, United States
City of Hope West Covina
West Covina, California, United States
City of Hope Atlanta Cancer Center
Newnan, Georgia, United States
City of Hope at Chicago
Zion, Illinois, United States
Countries
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Facility Contacts
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Richard T. Lee
Role: primary
Richard T. Lee
Role: primary
Richard T. Lee
Role: primary
Richard T. Lee
Role: primary
Richard T. Lee
Role: primary
Richard T. Lee
Role: primary
Richard T. Lee
Role: primary
Richard T. Lee
Role: primary
Richard T. Lee
Role: primary
Richard T. Lee
Role: primary
Richard T. Lee
Role: primary
Other Identifiers
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NCI-2025-07334
Identifier Type: REGISTRY
Identifier Source: secondary_id
25077
Identifier Type: OTHER
Identifier Source: secondary_id
25077
Identifier Type: -
Identifier Source: org_study_id