A Multicenter Prospective Observational Cohort Study Evaluating the Impact of Cancer-Directed Treatment and Medication Use, Including Cannabis Use, in Multiple Myeloma Patients

February 18, 2026 updated by: City of Hope Medical Center
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

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.

Study Type

Observational

Enrollment (Estimated)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Goodyear, Arizona, United States, 85338
        • Not yet recruiting
        • CTCA at Western Regional Medical Center
        • Contact:
        • Principal Investigator:
          • Richard T. Lee
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope Medical Center
        • Contact:
        • Principal Investigator:
          • Richard T. Lee
      • Huntington Beach, California, United States, 92648
        • Not yet recruiting
        • City of Hope Seacliff
        • Contact:
        • Principal Investigator:
          • Richard T. Lee
      • Irvine, California, United States, 92618
        • Recruiting
        • City of Hope at Irvine Lennar
        • Contact:
        • Principal Investigator:
          • Richard T. Lee
      • Long Beach, California, United States, 90813
        • Not yet recruiting
        • City of Hope at Long Beach Elm
        • Contact:
        • Principal Investigator:
          • Richard T. Lee
      • Newport Beach, California, United States, 92660
        • Not yet recruiting
        • City of Hope at Newport Beach Fashion Island
        • Contact:
        • Principal Investigator:
          • Richard T. Lee
      • South Pasadena, California, United States, 91030
        • Not yet recruiting
        • City of Hope South Pasadena
        • Contact:
        • Principal Investigator:
          • Richard T. Lee
      • Upland, California, United States, 91786
        • Not yet recruiting
        • City of Hope Upland
        • Contact:
        • Principal Investigator:
          • Richard T. Lee
      • West Covina, California, United States, 91790
        • Not yet recruiting
        • City of Hope West Covina
        • Contact:
        • Principal Investigator:
          • Richard T. Lee
    • Georgia
      • Newnan, Georgia, United States, 30265
        • Not yet recruiting
        • City of Hope Atlanta Cancer Center
        • Contact:
        • Principal Investigator:
          • Richard T. Lee
    • Illinois
      • Zion, Illinois, United States, 60099
        • Not yet recruiting
        • City of Hope at Chicago
        • Contact:
        • Principal Investigator:
          • Richard T. Lee

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

  • * 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

Exclusion Criteria:

  • * 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational group I
Patients complete surveys and undergo blood sample collection throughout the study.
Other: Non-Interventional Study
Non-interventional study
Other Names:
  • Non-Interventional Observational Study
  • Noninterventional (Observational) Study
Observational group II
Healthcare providers complete a survey on study.
Other: Non-Interventional Study
Non-interventional study
Other Names:
  • Non-Interventional Observational Study
  • Noninterventional (Observational) Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Longitudinal patterns in quality of life
Time Frame: Up to one year
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
Time Frame: Up to one year
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
Time Frame: Up to one year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Richard T Lee, City of Hope Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2026

Primary Completion (Estimated)

August 22, 2030

Study Completion (Estimated)

August 22, 2030

Study Registration Dates

First Submitted

October 16, 2025

First Submitted That Met QC Criteria

November 5, 2025

First Posted (Actual)

November 10, 2025

Study Record Updates

Last Update Posted (Actual)

February 20, 2026

Last Update Submitted That Met QC Criteria

February 18, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25077 (Other Identifier: City of Hope Medical Center)
  • P30CA033572 (U.S. NIH Grant/Contract)
  • NCI-2025-07334 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • U01CA286808 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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