A Multicenter Prospective Observational Cohort Study Evaluating the Impact of Cancer-Directed Treatment and Medication Use, Including Cannabis Use, in Multiple Myeloma Patients
4 other identifiers
observational
700
1 country
11
Brief Summary
This study assesses the impact of cannabis (also commonly called marijuana, weed, or THC) use on quality of life among patients with multiple myeloma who are receiving chemotherapy. It also evaluates the potential benefits and harms of cannabis use.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2026
Longer than P75 for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2025
CompletedFirst Posted
Study publicly available on registry
November 10, 2025
CompletedStudy Start
First participant enrolled
January 21, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 22, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 22, 2030
February 20, 2026
February 1, 2026
4.6 years
October 16, 2025
February 18, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Longitudinal patterns in quality of life
Will 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. The analysis will compare difference scores from the FACT-MM between these groups using ANOVA at the end of treatment. For comparisons between groups at four specific assessment points (baseline, C1, C2, C3, and C4), a repeated measures analysis of variance analysis will be performed. Multivariable mixed-effects regression model, which takes possible dependence of longitudinal measurements within each subject into account, will be used. The possible within-subject dependence will also be taken into account using the robust standard error (generalized estimating equation method) when statistical inferences are made with regards to the treatment effect and interaction between treatment and time period.
Up to one year
Potential therapeutic benefit and adverse effects associated with cannabis use
Will 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) through a comparative analysis of users and non-users. Descriptive statistics will be computed regarding reported benefits and harms of cannabis, and associations will be explored with the different type of cannabis utilized.
Up to one year
Potential therapeutic benefit and adverse effects associated with cannabis use
Will estimate and characterize the potential therapeutic benefit and adverse effects associated with cannabis use as assessed by medical assessments (Common Terminology Criteria for Adverse Events-CTCAE v5.0) through a comparative analysis of users and non-users. Descriptive statistics will be computed regarding reported benefits and harms of cannabis, and associations will be explored with the different type of cannabis utilized.
Up to one year
Study Arms (2)
Observational group I
Patients complete surveys and undergo blood sample collection throughout the study.
Observational group II
Healthcare providers complete a survey on study.
Interventions
Non-interventional study
Eligibility Criteria
Newly diagnosed multiple myeloma patients who have received up to four cycles of first line therapy and City of Hope affiliated health care providers currently practicing in oncology or providing direct care to oncology patients.
You may qualify if:
- \* Documented informed consent of the participant
- 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
You may not qualify if:
- \* Patients may not have completed five cycles of first line therapy or undergone any second line therapy
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- City of Hope Medical Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (11)
CTCA at Western Regional Medical Center
Goodyear, Arizona, 85338, United States
City of Hope Medical Center
Duarte, California, 91010, United States
City of Hope Seacliff
Huntington Beach, California, 92648, United States
City of Hope at Irvine Lennar
Irvine, California, 92618, United States
City of Hope at Long Beach Elm
Long Beach, California, 90813, United States
City of Hope at Newport Beach Fashion Island
Newport Beach, California, 92660, United States
City of Hope South Pasadena
South Pasadena, California, 91030, United States
City of Hope Upland
Upland, California, 91786, United States
City of Hope West Covina
West Covina, California, 91790, United States
City of Hope Atlanta Cancer Center
Newnan, Georgia, 30265, United States
City of Hope at Chicago
Zion, Illinois, 60099, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard T Lee
City of Hope Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2025
First Posted
November 10, 2025
Study Start
January 21, 2026
Primary Completion (Estimated)
August 22, 2030
Study Completion (Estimated)
August 22, 2030
Last Updated
February 20, 2026
Record last verified: 2026-02