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

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-24

Study Completion Date

2027-05-13

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Multiple Myeloma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational group I

Patients complete surveys and undergo blood sample collection throughout the study.

Non-Interventional Study

Intervention Type OTHER

Non-interventional study

Observational group II

Healthcare providers complete a survey on study.

Non-Interventional Study

Intervention Type OTHER

Non-interventional study

Interventions

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Non-Interventional Study

Non-interventional study

Intervention Type OTHER

Other Intervention Names

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Non-Interventional Observational Study Noninterventional (Observational) Study

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

City of Hope Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

City of Hope Medical Center

Duarte, California, United States

Site Status

City of Hope Seacliff

Huntington Beach, California, United States

Site Status

City of Hope at Irvine Lennar

Irvine, California, United States

Site Status

City of Hope at Long Beach Elm

Long Beach, California, United States

Site Status

City of Hope at Newport Beach Fashion Island

Newport Beach, California, United States

Site Status

City of Hope South Pasadena

South Pasadena, California, United States

Site Status

City of Hope Upland

Upland, California, United States

Site Status

City of Hope West Covina

West Covina, California, United States

Site Status

City of Hope Atlanta Cancer Center

Newnan, Georgia, United States

Site Status

City of Hope at Chicago

Zion, Illinois, United States

Site Status

Countries

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United States

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

P30CA033572

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U01CA286808

Identifier Type: NIH

Identifier Source: secondary_id

View Link

25077

Identifier Type: -

Identifier Source: org_study_id