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Recruiting NCT07225738

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

— Observational Multiple Myeloma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Non-Interventional Study.
Who it may be relevant to
Registry conditions: Multiple Myeloma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

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.

Interventions

  • Other Non-Interventional Study
    Non-interventional study

Primary outcome measures

  • Longitudinal patterns in quality of life [Time frame: Up to one year]
  • Potential therapeutic benefit and adverse effects associated with cannabis use [Time frame: Up to one year]
  • Potential therapeutic benefit and adverse effects associated with cannabis use [Time frame: Up to one year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 11 centers
  • CTCA at Western Regional Medical Center — Goodyear
  • City of Hope Medical Center — Duarte
  • City of Hope Seacliff — Huntington Beach
  • City of Hope at Irvine Lennar — Irvine
  • City of Hope at Long Beach Elm — Long Beach
  • City of Hope at Newport Beach Fashion Island — Newport Beach
  • City of Hope South Pasadena — South Pasadena
  • City of Hope Upland — Upland
  • … and 3 more centers

Identifiers

NCT: NCT07225738 · 25077 · NCI-2025-07334 · 25077 · P30CA033572 · U01CA286808

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗