Plasma Cell MyelomaNCT05918185
Evaluation of Comprehensive Geriatric Assessment and Laboratory Biomarkers in Elderly Patients With Multiple Myeloma
An observational study of Plasma Cell Myeloma, run by Mayo Clinic at 1 site in United States.
Trial summary
This study evaluates the association between a comprehensive geriatric assessment and laboratory biomarkers with the side effects of chemotherapy in older patients with multiple myeloma (MM). The comprehensive geriatric assessment is a tool that can help to determine how fit a patient is. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Plasma Cell Myeloma
- What is being tested?
- Biospecimen Collection, Comprehensive Geriatric Assessment and Electronic Health Record Review
- Type of treatment
- Surgery or procedure
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2023to 30 Aug 2025
- Phase
- Observational
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients over the age of 65 planned to start a new treatment for MM at Mayo Clinic in Rochester.
Who may be able to join
- Age >= 65 years
- Diagnosis of MM based on International Myeloma Working Group (IMWG) diagnostic criteria
- Newly diagnosed or have received 1 prior line of treatment
- Planned to start a new treatment for MM within 30 days
- Transplant eligible or ineligible
- Fluent in English (all assessment tools are in English)
- Able to provide written informed consent
Who cannot join
- Received > 1 prior line of treatment
- Patients included in an interventional therapeutic trial
- Not able to give informed consent
- Severe mental or cognitive disorder precluding geriatric assessment
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: The Role of the Comprehensive Geriatric Assessment in Elderly Patients With Multiple Myeloma: A Single Center Prospective Study
This study evaluates the association between a comprehensive geriatric assessment and laboratory biomarkers with the side effects of chemotherapy in older patients with multiple myeloma (MM). The comprehensive geriatric assessment is a tool that can help to determine how fit a patient is. It is composed of a series of questions and tests designed for older people to evaluate their physical function, mental status, mental health, nutritional status, social support, level of social activity, and the presence of other medical problems. In addition to geriatric assessment domains, laboratory biomarkers may provide information on physiologic dysfunction as a measure for evaluation of frailty in the cancer setting. This study will help researchers in the future by predicting which patients will have more side effects with chemotherapy based on their comprehensive geriatric assessment and laboratory biomarkers, which will allow adjustments to treatment in older adult patients with MM.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the association between a baseline comprehensive geriatric assessment (cGA) and chemotherapy toxicity in the first 4 months of treatment measured by treatment-related adverse events, patient-reported outcomes (PROs), and treatment discontinuation in older patients (>= 65 years) with multiple myeloma (MM).
SECONDARY OBJECTIVES:
- To evaluate the association between a baseline cGA and baseline disease- and host- related laboratory characteristics and cytogenetic risk profile by fluorescence in situ hybridization among newly diagnosed older (>= 65 years) patients with MM.
II. To evaluate how the cGA changes over 4 months from the start of treatment and the association between those changes and treatment response in older patients (>= 65 years) with MM.
III. To evaluate the association between proposed frailty biomarkers at baseline and treatment toxicity in the first 4 months of treatment measured by treatment-related adverse events, PROs, and treatment discontinuation in older (>= 65 years) patients with MM.
OUTLINE: This is an observational study.
Patients complete surveys and undergo cGA, blood sample collection, and electronic health record (EHR) review on study.
- Conditions
- Plasma Cell Myeloma
- Being tested
- Biospecimen Collection, Comprehensive Geriatric Assessment, Electronic Health Record Review, Survey Administration
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
Comprehensive Geriatric AssessmentOther
Undergo cGA
Electronic Health Record ReviewOther
Medical records are reviewed
Survey AdministrationOther
Complete surveys
| Study group | Role | What they receive |
|---|---|---|
| Observational (Surveys, cGA, blood sample, EHR review) | Patients complete surveys and undergo cGA, blood sample collection, and EHR review on study. Receives: Procedure: Biospecimen Collection; Other: Comprehensive Geriatric Assessment; Other: Electronic Health Record Review; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-related adverse events
Will graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The maximum observed grade per adverse event and capture grade >= 3 toxicities.
Measured: Up to 4 months
Secondary outcomes (3)
Chemotherapy toxicity
Will be analyzed longitudinally using toxicity over time analysis which measures adverse events over time, providing information on timing and evolution of symptoms during treatment.
Measured: Up to 4 months
Patient reported outcome (PRO) questionnaire
Will be assessed at the end of each treatment cycle (prior to each new cycle) at scheduled visits for a total of 4 months or until treatment discontinuation whichever comes first using the PRO Measurement Information System Global Health which is a 10-item questionnaire that assesses a patient's global heath. All questions have a five-point Likert-type scale, except for the rating of pain question which has a 10-point scale. Subscale scores can be generated for Global Physical Health and Global Mental for each patient.
Measured: Up to 4 months
Patient reported outcome (PRO-CTCAE) questionnaire
Select PRO-CTCAE symptomatic adverse event items to assess the presence, severity and interference of symptoms experienced by patients.
Measured: Up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start15 Feb 2023
- Primary completion30 Aug 2025
- Study completion30 Aug 2025
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 Plasma Cell MyelomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shaji K. Kumar, MD, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05918185
- Sponsor's protocol ID
- 21-010499
- Other IDs
- NCI-2022-06872, 21-010499
- Status last verified
- Jan 2026
- First submitted
- 17 May 2023
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abdallah N, Marar R, Yee C, Bodily A, Truman M, Wildes TM, Menser T, Weivoda M, Aug S, Smith B, Buadi F, Kapoor P, Dispenzieri A, Hayman S, Dingli D, Gonsalves W, Cook J, Zanwar S, Binder M, Kourelis T, Gertz M, Warsame R, Lin Y, Rajkumar SV, Dueck A, Kumar S. Self-reported geriatric impairments and treatment toxicity in older patients with multiple myeloma. Blood Adv. 2026 Oct 27;10(20):6957-6967. doi: 10.1182/bloodadvances.2026020579.
PubMed 42508993
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the Comprehensive Geriatric Assessment in Elderly Patients With Multiple Myeloma: A Single Center Prospective Study
- ClinicalTrials.gov ID
- NCT05918185
- Acronym / sponsor ID
- 21-010499
- Conditions
- Plasma Cell Myeloma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 26 Jun 2023 (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 evaluates the association between a comprehensive geriatric assessment and laboratory biomarkers with the side effects of chemotherapy in older patients with multiple myeloma (MM). The comprehensive geriatric assessment is a tool that can help to determine how fit a patient is. It is composed of a series of questions and tests designed for older people to evaluate their physical function, mental status, mental health, nutritional status, social support, level of social activity, and the presence of other medical problems. In addition to geriatric assessment domains, laboratory biomarkers may provide information on physiologic dysfunction as a measure for evaluation of frailty in the cancer setting. This study will help researchers in the future by predicting which patients will have more side effects with chemotherapy based on their comprehensive geriatric assessment and laboratory biomarkers, which will allow adjustments to treatment in older adult patients with MM.
Detailed description
PRIMARY OBJECTIVE:
- To evaluate the association between a baseline comprehensive geriatric assessment (cGA) and chemotherapy toxicity in the first 4 months of treatment measured by treatment-related adverse events, patient-reported outcomes (PROs), and treatment discontinuation in older patients (>= 65 years) with multiple myeloma (MM).
SECONDARY OBJECTIVES:
- To evaluate the association between a baseline cGA and baseline disease- and host- related laboratory characteristics and cytogenetic risk profile by fluorescence in situ hybridization among newly diagnosed older (>= 65 years) patients with MM.
II. To evaluate how the cGA changes over 4 months from the start of treatment and the association between those changes and treatment response in older patients (>= 65 years) with MM.
III. To evaluate the association between proposed frailty biomarkers at baseline and treatment toxicity in the first 4 months of treatment measured by treatment-related adverse events, PROs, and treatment discontinuation in older (>= 65 years) patients with MM.
OUTLINE: This is an observational study.
Patients complete surveys and undergo cGA, blood sample collection, and electronic health record (EHR) review on study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (Surveys, cGA, blood sample, EHR review) | – | Procedure: Biospecimen Collection, Other: Comprehensive Geriatric Assessment, Other: Electronic Health Record Review, Other: Survey AdministrationPatients complete surveys and undergo cGA, blood sample collection, and EHR review on study. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients over the age of 65 planned to start a new treatment for MM at Mayo Clinic in Rochester.
Key inclusion criteria (7 listed)
- Age >= 65 years
- Diagnosis of MM based on International Myeloma Working Group (IMWG) diagnostic criteria
- Newly diagnosed or have received 1 prior line of treatment
- Planned to start a new treatment for MM within 30 days
- Transplant eligible or ineligible
Key exclusion criteria (4 listed)
- Received > 1 prior line of treatment
- Patients included in an interventional therapeutic trial
- Not able to give informed consent
- Severe mental or cognitive disorder precluding geriatric assessment
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 |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Observational (Surveys, cGA, blood sample, EHR review) |
| Comprehensive Geriatric AssessmentUndergo cGA | Other | Observational (Surveys, cGA, blood sample, EHR review) |
| Electronic Health Record ReviewMedical records are reviewed | Other | Observational (Surveys, cGA, blood sample, EHR review) |
| Survey AdministrationComplete surveys | Other | Observational (Surveys, cGA, blood sample, EHR review) |
Primary outcome
Incidence of treatment-related adverse events
Time frame: Up to 4 months
Will graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The maximum observed grade per adverse event and capture grade >= 3 toxicities.
3 secondary outcomes
Chemotherapy toxicity
Time frame: Up to 4 months
Patient reported outcome (PRO) questionnaire
Time frame: Up to 4 months
Patient reported outcome (PRO-CTCAE) questionnaire
Time frame: Up to 4 months
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 3 Feb 2026.
- Derived from this study: PubMed 42508993Abdallah N, Marar R, Yee C, Bodily A, Truman M, Wildes TM, Menser T, Weivoda M, Aug S, Smith B, Buadi F, Kapoor P, Dispenzieri A, Hayman S, Dingli D, Gonsalves W, Cook J, Zanwar S, Binder M, Kourelis T, Gertz M, Warsame R, Lin Y, Rajkumar SV, Dueck A, Kumar S. Self-reported geriatric impairments and treatment toxicity in older patients with multiple myeloma. Blood Adv. 2026 Oct 27;10(20):6957-6967. doi: 10.1182/bloodadvances.2026020579.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
Related trials for Plasma Cell Myeloma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
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RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
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Active, not recruitingPhase 2
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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.
Shaji K. Kumar, MD principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plasma Cell Myeloma, run by Mayo Clinic 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 7 inclusion and 4 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 3 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 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?
Incidence of treatment-related adverse events (time frame: Up to 4 months). 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 NCT05918185, 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 3 Feb 2026.