Multiple MyelomaNCT07225738
A Multicenter Prospective Observational Cohort Study Evaluating the Impact of Cancer-Directed Treatment and Medication Use, Including Cannabis Use, in Multiple Myeloma Patients
An observational study of Multiple Myeloma, run by City of Hope Medical Center at 11 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Non-Interventional Study
- How many people
- 700 participants
- Where
- 11 sitesUnited States
- Study dates
- 21 Jan 2026to 22 Aug 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- * 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
Show all 12Show fewer
- 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
Who cannot join
- * 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
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
United States11 sites, 11 recruiting
- Recruiting
City of Hope Medical Center
Duarte, California, 91010
Richard T. Lee, 949-671-4091, RichLee@coh.org
Richard T. Lee
- Not yet recruiting
CTCA at Western Regional Medical Center
Goodyear, Arizona, 85338
Richard T. Lee, 949-671-4091, RichLee@coh.org
Richard T. Lee
- Not yet recruiting
City of Hope Seacliff
Huntington Beach, California, 92648
Richard T. Lee, 949-671-4091, RichLee@coh.org
Richard T. Lee
- Recruiting
City of Hope at Irvine Lennar
Irvine, California, 92618
Richard T. Lee, 949-671-4091, RichLee@coh.org
Richard T. Lee
- Not yet recruiting
City of Hope at Long Beach Elm
Long Beach, California, 90813
Richard T. Lee, 949-671-4091, RichLee@coh.org
Richard T. Lee
- Not yet recruiting
City of Hope Atlanta Cancer Center
Newnan, Georgia, 30265
Richard T. Lee, 949-671-4091, RichLee@coh.org
Richard T. Lee
- Not yet recruiting
City of Hope at Newport Beach Fashion Island
Newport Beach, California, 92660
Richard T. Lee, 949-671-4091, RichLee@coh.org
Richard T. Lee
- Not yet recruiting
City of Hope South Pasadena
South Pasadena, California, 91030
Richard T. Lee, 949-671-4091, RichLee@coh.org
Richard T. Lee
- Not yet recruiting
City of Hope Upland
Upland, California, 91786
Richard T. Lee, 949-671-4091, RichLee@coh.org
Richard T. Lee
- Not yet recruiting
City of Hope West Covina
West Covina, California, 91790
Richard T. Lee, 949-671-4091, RichLee@coh.org
Richard T. Lee
- Not yet recruiting
City of Hope at Chicago
Zion, Illinois, 60099
Richard T. Lee, 949-671-4091, RichLee@coh.org
Richard T. Lee
About this study
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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
- Multiple Myeloma
- Being tested
- Non-Interventional Study
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Also called Non-Interventional Observational Study, Noninterventional (Observational) Study
Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| Observational group I | Patients complete surveys and undergo blood sample collection throughout the study. Receives: Other: Non-Interventional Study | |
| Observational group II | Healthcare providers complete a survey on study. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal patterns in quality of life
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.
Measured: Up to one year
Potential therapeutic benefit and adverse effects associated with cannabis use
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.
Measured: Up to one year
Potential therapeutic benefit and adverse effects associated with cannabis use
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.
Measured: Up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2025
- Study start21 Jan 2026
- Primary completion22 Aug 2030 (estimated)
- Study completion22 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Richard T Lee, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07225738
- Sponsor's protocol ID
- 25077
- Other IDs
- NCI-2025-07334, 25077, P30CA033572, U01CA286808
- Status last verified
- Feb 2026
- First submitted
- 16 Oct 2025
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Observational Cohort Study Evaluating the Impact of Cancer-Directed Treatment and Medication Use, Including Cannabis Use, in Multiple Myeloma Patients
- ClinicalTrials.gov ID
- NCT07225738
- Acronym / sponsor ID
- 25077
- Conditions
- Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 21 Jan 2026 (actual)
- Primary completion
- 22 Aug 2030 (estimated)
- Study completion
- 22 Aug 2030 (estimated)
- First posted
- 10 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observational group I | – | Other: Non-Interventional StudyPatients complete surveys and undergo blood sample collection throughout the study. |
| Observational group II | – | Other: Non-Interventional StudyHealthcare providers complete a survey on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- * Documented informed consent of the participant
Key exclusion criteria (7 listed)
- * Patients may not have completed five cycles of first line therapy or undergone any second line therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Interventional StudyAlso: Non-Interventional Observational Study, Noninterventional (Observational) StudyNon-interventional study | Other | Observational group I, Observational group II |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
Related trials for Multiple Myeloma
RecruitingObservational study
The Indiana Myeloma Registry
Plasma Cell Dyscrasias
RecruitingPhase 2
A Study of Selinexor (Seli) + Low-dose Dexamethasone (LDD) in Penta-refractory Multiple Myeloma (MM), Seli and Bortezomib + LDD in Triple-class Refractory MM.
Multiple Myeloma, Refractory
Not yet recruitingPhase 3
A Trial Comparing Ramantamig and Daratumumab (Ramantamig-D) Versus Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone in Participants With Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible
Multiple Myeloma
RecruitingPhase 1
Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Participant-specific Neoantigens in Patients With Hematologic Malignancies
Malignancy, Hematologic, Neoplasms, Hematologic
Not yet recruitingPhase 2
QLS4131 for Relapsed/Refractory Multiple Myeloma With Extramedullary Disease
Multiple Myeloma (MM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Richard T Lee principal investigator
City of Hope Medical Center
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by City of Hope Medical Center at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Longitudinal patterns in quality of life (time frame: Up to one year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.