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

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CTCA at Western Regional Medical Center, Goodyear, Arizona, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Interventional Study

Other

Non-interventional study

Other names: Non-Interventional Observational Study, Noninterventional (Observational) Study

Primary outcomes

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.
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.
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.

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

National Cancer Institute (NCI)

Registry information

Important dates

Study start: 2026
Primary completion: 2030
Study completion: 2030
First posted: Nov 10, 2025
Registry last updated: Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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