Multiple MyelomaNCT04248244
Effects of Early Palliative Care Integration on Patients With Newly Diagnosed Multiple Myeloma
A study testing Palliative Care, FACT-MM questionnaire and HADS questionnaire in people with Multiple Myeloma, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
Multiple Myeloma (MM) is a common type of cancer involving the cells in the blood (commonly affecting bones, kidneys and blood). Although it remains incurable, MM has become a highly treatable form cancer thanks to new and improved treatment modalities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Palliative Care, FACT-MM questionnaire and HADS questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2020to 26 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be within eight weeks of being diagnosed with symptomatic MM based on current diagnostic criteria
- Able to read and respond to questions in English
- Have an ECOG performance status of 0, 1, 2 or 3
- Receiving oncologic care at a Cleveland Clinic facility
Who cannot join
- Have seen a PC provider in any setting (i.e., inpatient, outpatient or home-based)
- Need immediate referral to PC for hospice transition
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
About this study
Official title: A Pilot Study to Determine the Effects of Early Palliative Care Integration on Patients With Newly Diagnosed Multiple Myeloma
Multiple Myeloma (MM) is a common type of cancer involving the cells in the blood (commonly affecting bones, kidneys and blood). Although it remains incurable, MM has become a highly treatable form cancer thanks to new and improved treatment modalities. As patients deal with this disease, they often suffer from multiple symptoms that are caused by both the disease itself and the different drugs used to treat it. Research has shown that the most common symptoms patients suffer from include pain, constipation, tiredness, tingling in hands and feet, breathlessness, sadness and difficulty remembering things. These symptoms may negatively affect the quality of life of patients.
Palliative care (PC) is a type of treatment aimed at relieving symptoms and promoting the most optimal quality of life (QOL) for patients and their caregivers. Research has shown that patients with certain types of cancers, such as colon cancer and lung cancer, do better if they are seen by a PC provider early in the course of their disease. This study seeks to determine the effects of early PC involvement on participants with newly diagnosed MM
Read the detailed description
This is a pilot study with a prospective cohort design, and based in the outpatient or ambulatory care setting. Each participant will be followed for 12 months.
Twenty eligible patients will be enrolled, and within eight weeks of diagnosis. Patients will meet with a member of the outpatient PC team, which consists of board-certified PC physicians, advance practice providers and nurse care coordinators, within three weeks of enrollment. Additional visits may be scheduled at the discretion of participants, oncologists or PC providers and participants will receive routine oncologic care throughout the study period.
The primary objective of this study is to obtain preliminary data on the effects of early PC involvement in a cohort of patients with newly diagnosed symptomatic MM
The secondary objectives of this study are to assess self-reported QOL, estimate the change in QOL relative to baseline, estimate number of participants with self-reported symptoms of depression and anxiety, to determine if monthly PC visits are feasible for participants, and to estimate health services utilization.
- Conditions
- Multiple Myeloma
- Being tested
- Palliative Care, FACT-MM questionnaire, HADS questionnaire
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palliative CareOther
Early PC Integration - Participants will meet with a member of the outpatient PC team, which consists of board-certified PC physicians, advance practice providers and nurse care coordinators, within three weeks of enrollment. Participants will be scheduled to meet with a PC provider at least once per month. Additional visits may be scheduled at the discretion of participants, oncologists or PC providers. All participants will receive routine oncologic care throughout the study period.
FACT-MM questionnaireOther
FACT-MM questionnaires will be administered by a research coordinator upon enrollment and at four time points from the date of enrollment: 3 months, 6 months, 9 months and 12 months. All questionnaires will be administered in handwritten paper-based form, and while patients are in clinic. There is a +/- two-week window for completion of questionnaires to accommodate patient schedules. The assessment battery takes approximately 20 minutes to complete.
HADS questionnaireOther
HADS questionnaires will be administered by a research coordinator upon enrollment and at four time points from the date of enrollment: 3 months, 6 months, 9 months and 12 months. All questionnaires will be administered in handwritten paper-based form, and while patients are in clinic. There is a +/- two-week window for completion of questionnaires to accommodate patient schedules. The assessment battery takes approximately 20 minutes to complete.
| Study group | Role | What they receive |
|---|---|---|
| Early Palliative Care Integration | Experimental | 12 months of PC with concurrent standard treatment for MM, QOL assessments Receives: Other: Palliative Care; Other: FACT-MM questionnaire; Other: HADS questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported QOL as measured by FACT-MM scores
Self-reported QOL as measured by FACT-MM scores
The questionnaire is a combination of the original widely used and validated FACT-G (Functional Assessment of Cancer Therapy-General) questionnaire (27 items), and 14 MM-specific items.
FACT-MM total scores range from 0 to 164, with FACT-G sections ranging from 0 to 108 and MM-specific section ranging from 0 to 56.
Higher scores mean better QOL for all sections and total scores.
Measured: At baseline
Self-reported QOL as measured by FACT-MM scores
Self-reported QOL as measured by FACT-MM scores The questionnaire is a combination of the original widely used and validated FACT-G (Functional Assessment of Cancer Therapy-General) questionnaire (27 items), and 14 MM-specific items.
FACT-MM total scores range from 0 to 164, with FACT-G sections ranging from 0 to 108 and MM-specific section ranging from 0 to 56.
Higher scores mean better QOL for all sections and total scores.
Measured: 3 months
Self-reported QOL as measured by FACT-MM scores
Self-reported QOL as measured by FACT-MM scores The questionnaire is a combination of the original widely used and validated FACT-G (Functional Assessment of Cancer Therapy-General) questionnaire (27 items), and 14 MM-specific items.
FACT-MM total scores range from 0 to 164, with FACT-G sections ranging from 0 to 108 and MM-specific section ranging from 0 to 56.
Higher scores mean better QOL for all sections and total scores.
Measured: 6 months
Self-reported QOL as measured by FACT-MM scores
Self-reported QOL as measured by FACT-MM scores The questionnaire is a combination of the original widely used and validated FACT-G (Functional Assessment of Cancer Therapy-General) questionnaire (27 items), and 14 MM-specific items.
FACT-MM total scores range from 0 to 164, with FACT-G sections ranging from 0 to 108 and MM-specific section ranging from 0 to 56.
Higher scores mean better QOL for all sections and total scores.
Measured: 9 months
Self-reported QOL as measured by FACT-MM scores
Self-reported QOL as measured by FACT-MM scores The questionnaire is a combination of the original widely used and validated FACT-G (Functional Assessment of Cancer Therapy-General) questionnaire (27 items), and 14 MM-specific items.
FACT-MM total scores range from 0 to 164, with FACT-G sections ranging from 0 to 108 and MM-specific section ranging from 0 to 56.
Higher scores mean better QOL for all sections and total scores.
Measured: 12 months
Change in QOL relative to baseline as measured by FACT-MM scores
Change in QOL relative to baseline as measured by FACT-MM scores.
The questionnaire is a combination of the original widely used and validated FACT-G (Functional Assessment of Cancer Therapy-General) questionnaire (27 items), and 14 MM-specific items.
FACT-MM total scores range from 0 to 164, with FACT-G sections ranging from 0 to 108 and MM-specific section ranging from 0 to 56.
Higher scores mean better QOL for all sections and total scores.
Measured: 3 months, 6 months, 9 months and 12 months
Number of participants with self-reported symptoms of depression and anxiety
Number of participants with self-reported symptoms of depression and anxiety as measured by HADS questionnaire. The questionnaire consists of 14 items, two subscales (depression and anxiety) of seven questions each for depression and anxiety. Each subsection has a possible score range of 0 to 21, with higher scores indicating worse outcomes. A score of greater than or equal to eight on either subscale is considered clinically significant (i.e., probable depression or anxiety).
Measured: At baseline
Number of participants with self-reported symptoms of depression and anxiety
Number of participants with self-reported symptoms of depression and anxiety as measured by HADS questionnaire. The questionnaire consists of 14 items, two subscales (depression and anxiety) of seven questions each for depression and anxiety. Each subsection has a possible score range of 0 to 21, with higher scores indicating worse outcomes. A score of greater than or equal to eight on either subscale is considered clinically significant (i.e., probable depression or anxiety).
Measured: 3 months
Number of participants with self-reported symptoms of depression and anxiety
Number of participants with self-reported symptoms of depression and anxiety as measured by HADS questionnaire. The questionnaire consists of 14 items, two subscales (depression and anxiety) of seven questions each for depression and anxiety. Each subsection has a possible score range of 0 to 21, with higher scores indicating worse outcomes. A score of greater than or equal to eight on either subscale is considered clinically significant (i.e., probable depression or anxiety).
Measured: 6 months
Number of participants with self-reported symptoms of depression and anxiety
Number of participants with self-reported symptoms of depression and anxiety as measured by HADS questionnaire. The questionnaire consists of 14 items, two subscales (depression and anxiety) of seven questions each for depression and anxiety. Each subsection has a possible score range of 0 to 21, with higher scores indicating worse outcomes. A score of greater than or equal to eight on either subscale is considered clinically significant (i.e., probable depression or anxiety).
Measured: 9 months
Number of participants with self-reported symptoms of depression and anxiety
Number of participants with self-reported symptoms of depression and anxiety as measured by HADS questionnaire. The questionnaire consists of 14 items, two subscales (depression and anxiety) of seven questions each for depression and anxiety. Each subsection has a possible score range of 0 to 21, with higher scores indicating worse outcomes. A score of greater than or equal to eight on either subscale is considered clinically significant (i.e., probable depression or anxiety).
Measured: 12 months
Number of PC visits made in the first 12 months after diagnosis
Feasibility of monthly PC visits as measured by the number of PC visits made in the first 12 months after diagnosis
Measured: At 12 months
Health services utilization as measured by number of ER visits, hospital admissions or ICU admissions
Health services utilization as measured by number of ER visits, hospital admissions or ICU admissions
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start17 Feb 2020
- Primary completion26 Oct 2022
- Study completion26 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Renato Samala, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04248244
- Sponsor's protocol ID
- CASE2A19
- Status last verified
- Aug 2025
- First submitted
- 23 Jan 2020
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data from this pilot study will be used to design and power a larger prospective study.
Publications
Samala RV, Nurse DP, Chen X, Wei W, Crook JJ, Fada SD, Valent J. Effects of early palliative care integration on patients with newly diagnosed multiple myeloma. Support Care Cancer. 2024 Jun 27;32(7):468. doi: 10.1007/s00520-024-08665-2.
PubMed 38937310
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Determine the Effects of Early Palliative Care Integration on Patients With Newly Diagnosed Multiple Myeloma
- ClinicalTrials.gov ID
- NCT04248244
- Acronym / sponsor ID
- CASE2A19
- Conditions
- Multiple Myeloma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 17 Feb 2020 (actual)
- Primary completion
- 26 Oct 2022 (actual)
- Study completion
- 26 Oct 2022 (actual)
- First posted
- 30 Jan 2020 (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.
Multiple Myeloma (MM) is a common type of cancer involving the cells in the blood (commonly affecting bones, kidneys and blood). Although it remains incurable, MM has become a highly treatable form cancer thanks to new and improved treatment modalities. As patients deal with this disease, they often suffer from multiple symptoms that are caused by both the disease itself and the different drugs used to treat it. Research has shown that the most common symptoms patients suffer from include pain, constipation, tiredness, tingling in hands and feet, breathlessness, sadness and difficulty remembering things. These symptoms may negatively affect the quality of life of patients.
Palliative care (PC) is a type of treatment aimed at relieving symptoms and promoting the most optimal quality of life (QOL) for patients and their caregivers. Research has shown that patients with certain types of cancers, such as colon cancer and lung cancer, do better if they are seen by a PC provider early in the course of their disease. This study seeks to determine the effects of early PC involvement on participants with newly diagnosed MM
Detailed description
This is a pilot study with a prospective cohort design, and based in the outpatient or ambulatory care setting. Each participant will be followed for 12 months.
Twenty eligible patients will be enrolled, and within eight weeks of diagnosis. Patients will meet with a member of the outpatient PC team, which consists of board-certified PC physicians, advance practice providers and nurse care coordinators, within three weeks of enrollment. Additional visits may be scheduled at the discretion of participants, oncologists or PC providers and participants will receive routine oncologic care throughout the study period.
The primary objective of this study is to obtain preliminary data on the effects of early PC involvement in a cohort of patients with newly diagnosed symptomatic MM
The secondary objectives of this study are to assess self-reported QOL, estimate the change in QOL relative to baseline, estimate number of participants with self-reported symptoms of depression and anxiety, to determine if monthly PC visits are feasible for participants, and to estimate health services utilization.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Early Palliative Care Integration | Experimental | Other: Palliative Care, Other: FACT-MM questionnaire, Other: HADS questionnaire12 months of PC with concurrent standard treatment for MM, QOL assessments |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must be within eight weeks of being diagnosed with symptomatic MM based on current diagnostic criteria
- Able to read and respond to questions in English
- Have an ECOG performance status of 0, 1, 2 or 3
- Receiving oncologic care at a Cleveland Clinic facility
Key exclusion criteria (2 listed)
- Have seen a PC provider in any setting (i.e., inpatient, outpatient or home-based)
- Need immediate referral to PC for hospice transition
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 |
|---|---|---|
| Palliative CareEarly PC Integration - Participants will meet with a member of the outpatient PC team, which consists of board-certified PC physicians, advance practice providers and nurse care coordinators, within three weeks of enrollment. Participants will be scheduled to meet with a PC provider at least once per month. Additional visits may be scheduled at the discretion of participants, oncologists or PC providers. All participants will receive routine oncologic care throughout the study period. | Other | Early Palliative Care Integration |
| FACT-MM questionnaireFACT-MM questionnaires will be administered by a research coordinator upon enrollment and at four time points from the date of enrollment: 3 months, 6 months, 9 months and 12 months. All questionnaires will be administered in handwritten paper-based form, and while patients are in clinic. There is a +/- two-week window for completion of questionnaires to accommodate patient schedules. The assessment battery takes approximately 20 minutes to complete. | Other | Early Palliative Care Integration |
| HADS questionnaireHADS questionnaires will be administered by a research coordinator upon enrollment and at four time points from the date of enrollment: 3 months, 6 months, 9 months and 12 months. All questionnaires will be administered in handwritten paper-based form, and while patients are in clinic. There is a +/- two-week window for completion of questionnaires to accommodate patient schedules. The assessment battery takes approximately 20 minutes to complete. | Other | Early Palliative Care Integration |
Primary outcome
Self-reported QOL as measured by FACT-MM scores
Time frame: At baseline
Self-reported QOL as measured by FACT-MM scores The questionnaire is a combination of the original widely used and validated FACT-G (Functional Assessment of Cancer Therapy-General) questionnaire (27 items), and 14 MM-specific items. FACT-MM total scores range from 0 to 164, with FACT-G sections ranging from 0 to 108 and MM-specific section ranging from 0 to 56. Higher scores mean better QOL for all sections and total scores.
Self-reported QOL as measured by FACT-MM scores
Time frame: 3 months
Self-reported QOL as measured by FACT-MM scores The questionnaire is a combination of the original widely used and validated FACT-G (Functional Assessment of Cancer Therapy-General) questionnaire (27 items), and 14 MM-specific items. FACT-MM total scores range from 0 to 164, with FACT-G sections ranging from 0 to 108 and MM-specific section ranging from 0 to 56. Higher scores mean better QOL for all sections and total scores.
Self-reported QOL as measured by FACT-MM scores
Time frame: 6 months
Self-reported QOL as measured by FACT-MM scores The questionnaire is a combination of the original widely used and validated FACT-G (Functional Assessment of Cancer Therapy-General) questionnaire (27 items), and 14 MM-specific items. FACT-MM total scores range from 0 to 164, with FACT-G sections ranging from 0 to 108 and MM-specific section ranging from 0 to 56. Higher scores mean better QOL for all sections and total scores.
Self-reported QOL as measured by FACT-MM scores
Time frame: 9 months
Self-reported QOL as measured by FACT-MM scores The questionnaire is a combination of the original widely used and validated FACT-G (Functional Assessment of Cancer Therapy-General) questionnaire (27 items), and 14 MM-specific items. FACT-MM total scores range from 0 to 164, with FACT-G sections ranging from 0 to 108 and MM-specific section ranging from 0 to 56. Higher scores mean better QOL for all sections and total scores.
Self-reported QOL as measured by FACT-MM scores
Time frame: 12 months
Self-reported QOL as measured by FACT-MM scores The questionnaire is a combination of the original widely used and validated FACT-G (Functional Assessment of Cancer Therapy-General) questionnaire (27 items), and 14 MM-specific items. FACT-MM total scores range from 0 to 164, with FACT-G sections ranging from 0 to 108 and MM-specific section ranging from 0 to 56. Higher scores mean better QOL for all sections and total scores.
Change in QOL relative to baseline as measured by FACT-MM scores
Time frame: 3 months, 6 months, 9 months and 12 months
Change in QOL relative to baseline as measured by FACT-MM scores. The questionnaire is a combination of the original widely used and validated FACT-G (Functional Assessment of Cancer Therapy-General) questionnaire (27 items), and 14 MM-specific items. FACT-MM total scores range from 0 to 164, with FACT-G sections ranging from 0 to 108 and MM-specific section ranging from 0 to 56. Higher scores mean better QOL for all sections and total scores.
Number of participants with self-reported symptoms of depression and anxiety
Time frame: At baseline
Number of participants with self-reported symptoms of depression and anxiety as measured by HADS questionnaire. The questionnaire consists of 14 items, two subscales (depression and anxiety) of seven questions each for depression and anxiety. Each subsection has a possible score range of 0 to 21, with higher scores indicating worse outcomes. A score of greater than or equal to eight on either subscale is considered clinically significant (i.e., probable depression or anxiety).
Number of participants with self-reported symptoms of depression and anxiety
Time frame: 3 months
Number of participants with self-reported symptoms of depression and anxiety as measured by HADS questionnaire. The questionnaire consists of 14 items, two subscales (depression and anxiety) of seven questions each for depression and anxiety. Each subsection has a possible score range of 0 to 21, with higher scores indicating worse outcomes. A score of greater than or equal to eight on either subscale is considered clinically significant (i.e., probable depression or anxiety).
Number of participants with self-reported symptoms of depression and anxiety
Time frame: 6 months
Number of participants with self-reported symptoms of depression and anxiety as measured by HADS questionnaire. The questionnaire consists of 14 items, two subscales (depression and anxiety) of seven questions each for depression and anxiety. Each subsection has a possible score range of 0 to 21, with higher scores indicating worse outcomes. A score of greater than or equal to eight on either subscale is considered clinically significant (i.e., probable depression or anxiety).
Number of participants with self-reported symptoms of depression and anxiety
Time frame: 9 months
Number of participants with self-reported symptoms of depression and anxiety as measured by HADS questionnaire. The questionnaire consists of 14 items, two subscales (depression and anxiety) of seven questions each for depression and anxiety. Each subsection has a possible score range of 0 to 21, with higher scores indicating worse outcomes. A score of greater than or equal to eight on either subscale is considered clinically significant (i.e., probable depression or anxiety).
Number of participants with self-reported symptoms of depression and anxiety
Time frame: 12 months
Number of participants with self-reported symptoms of depression and anxiety as measured by HADS questionnaire. The questionnaire consists of 14 items, two subscales (depression and anxiety) of seven questions each for depression and anxiety. Each subsection has a possible score range of 0 to 21, with higher scores indicating worse outcomes. A score of greater than or equal to eight on either subscale is considered clinically significant (i.e., probable depression or anxiety).
Number of PC visits made in the first 12 months after diagnosis
Time frame: At 12 months
Feasibility of monthly PC visits as measured by the number of PC visits made in the first 12 months after diagnosis
Health services utilization as measured by number of ER visits, hospital admissions or ICU admissions
Time frame: At 12 months
Health services utilization as measured by number of ER visits, hospital admissions or ICU admissions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Derived from this study: PubMed 38937310Samala RV, Nurse DP, Chen X, Wei W, Crook JJ, Fada SD, Valent J. Effects of early palliative care integration on patients with newly diagnosed multiple myeloma. Support Care Cancer. 2024 Jun 27;32(7):468. doi: 10.1007/s00520-024-08665-2.
- Publication linkLink provided by the sponsor.
- Individual participant dataSharing planned: No. Data from this pilot study will be used to design and power a larger prospective study.
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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. This study is not recruiting at the moment.
Renato Samala, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palliative Care, FACT-MM questionnaire and HADS questionnaire in people with Multiple Myeloma, run by Case Comprehensive Cancer Center at 1 site 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported QOL as measured by FACT-MM scores (time frame: At baseline). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04248244, which also lists 1 linked publication.
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 11 Aug 2025.