Myeloma, MultipleNCT02033928
Comprehensive Frailty Assessment
An observational study of Myeloma, Multiple and Paraproteinemias, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
The purpose of this research study is to describe a patients' fitness before and after treatment (whether that treatment be chemotherapy or a transplant). Fitness is a way of measuring a patient's current quality of health. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloma, Multiple, Paraproteinemias, Hematologic Neoplasms
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Aug 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients at The Ohio State University with a plamsa cell dyscrasia and/or any patient receiving a blood or marrow transplant at Ohio State will be considered for this study.
Who may be able to join
- patients with a plasma cell dyscrasia AND/OR any patient receiving a stem cell transplant for a hematologic malignancy at The Ohio State University
- at least 18 years of age
Who cannot join
- Any medical or psychiatric condition that would make it difficult for the patient to comply with study procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Hospital East
Columbus, Ohio, 43205
About this study
The purpose of this research study is to describe a patients' fitness before and after treatment (whether that treatment be chemotherapy or a transplant). Fitness is a way of measuring a patient's current quality of health. With surveys, questionnaires and blood tests, we hope to create a tool that will give a good picture of patients' ability to tolerate treatment. In the future, we hope to devise the best treatment for a patient based on their "fitness".
- Conditions
- Myeloma, Multiple, Paraproteinemias, Hematologic Neoplasms
- Keywords
- Myeloma, MGUS (monoclonal gammopathy of undetermined significance), amyloidosis, stem cell transplant
- Medical subject headings
- Multiple Myeloma, Paraproteinemias, Hematologic Neoplasms, Neoplasms, Plasma Cell, Monoclonal Gammopathy of Undetermined Significance, Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Arm I: Transplant patients | Not described | |
| Arm II: Plasma cell dyscrasia patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Comprehensive Frailty Assessment
Responses to the Comprehensive Frailty Assessment will be assessed before and after treatment and changes will be evaluated. In transplant patients, this will be measured one year post transplant and in the non-transplant arm, this will be assessed after the second cycle of treatment.
Measured: up to 14 months
Secondary outcomes (1)
Time to progression
We will assess time to progression for multiple myeloma patients and the relationships of those outcomes to patients' functional, cognitive and psychosocial health.
Measured: date of enrollment to date of documented clinical progression up to two years post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2014 (estimated)
- Study startApr 2014
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloma, MultipleStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashley Rosko, Ohio State University Comprehensive Cancer Center
- Investigators
- Ashley Rosko, MD, Principal investigator, The Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02033928
- Sponsor's protocol ID
- OSU-13135
- Status last verified
- Feb 2018
- First submitted
- 18 Dec 2013
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Frailty Assessment
- ClinicalTrials.gov ID
- NCT02033928
- Acronym / sponsor ID
- OSU-13135
- Conditions
- Myeloma, Multiple, Paraproteinemias, Hematologic Neoplasms
- Keywords
- Myeloma, MGUS (monoclonal gammopathy of undetermined significance), amyloidosis, stem cell transplant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 13 Jan 2014 (estimated)
- 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.
The purpose of this research study is to describe a patients' fitness before and after treatment (whether that treatment be chemotherapy or a transplant). Fitness is a way of measuring a patient's current quality of health. With surveys, questionnaires and blood tests, we hope to create a tool that will give a good picture of patients' ability to tolerate treatment. In the future, we hope to devise the best treatment for a patient based on their "fitness".
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I: Transplant patients | – | – |
| Arm II: Plasma cell dyscrasia patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at The Ohio State University with a plamsa cell dyscrasia and/or any patient receiving a blood or marrow transplant at Ohio State will be considered for this study.
Key inclusion criteria (2 listed)
- patients with a plasma cell dyscrasia AND/OR any patient receiving a stem cell transplant for a hematologic malignancy at The Ohio State University
- at least 18 years of age
Key exclusion criteria (1 listed)
- Any medical or psychiatric condition that would make it difficult for the patient to comply with study procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Comprehensive Frailty Assessment
Time frame: up to 14 months
Responses to the Comprehensive Frailty Assessment will be assessed before and after treatment and changes will be evaluated. In transplant patients, this will be measured one year post transplant and in the non-transplant arm, this will be assessed after the second cycle of treatment.
1 secondary outcome
Time to progression
Time frame: date of enrollment to date of documented clinical progression up to two years post-enrollment
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 28 Feb 2018.
- The JameslineLink provided by the sponsor.
Related trials for Myeloma, Multiple
RecruitingObservational study
The Indiana Myeloma Registry
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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
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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. This study is not recruiting at the moment.
Ashley Rosko, MD principal investigator
The Ohio State University Comprehensive Cancer Center
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 Myeloma, Multiple and Paraproteinemias, run by Ohio State University 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 2 inclusion and 1 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 28 Feb 2018. 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?
Change in Comprehensive Frailty Assessment (time frame: up to 14 months). 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 28 Feb 2018.