Clinical trial · Observational
A Multicenter Prospective Observational Cohort Study Evaluating the Impact of Cancer-Directed Treatment and Medication Use, Including Cannabis Use, in Multiple Myeloma Patients
NCT07225738CI-TRIAL-00103707recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non-Interventional Study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Observational group I
- description
- Patients complete surveys and undergo blood sample collection throughout the study.
- interventionNames
- Other: Non-Interventional Study
- label
- Observational group II
- description
- Healthcare providers complete a survey on study.
- interventionNames
- Other: Non-Interventional Study
Primary outcomes (3)
- measure
- Longitudinal patterns in quality of life
- timeFrame
- Up to one year
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.