Multiple Myeloma Patient Registry
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 17-008934
NCT ID: NCT03180853
Sponsor Protocol Number: NOPRODMMY4001
About this study
The purpose of this study is to document the participants characteristics, disease burden, and clinical management of participants in the United States who are treated for relapsed multiple myeloma in routine medical practice with a treatment strategies that include a proteasome inhibitor (PI) and/or immunomodulatory drug (IMiD) used either as monotherapy or combination therapy with other treatments.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Must sign, and/or their legally acceptable representative where applicable must sign, a participation agreement/informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements
- Have a diagnosis of relapsed multiple myeloma [according to International Myeloma Working Group (IMWG) criteria] with 1 to 3 prior lines of therapy. (An induction regimen followed by autologous stem cell transplantation and single-agent maintenance therapy will be considered a single line of therapy.)
- Participants must have initiated a new line of induction therapy that includes a proteasome inhibitor (PI) and/or immunomodulatory drug (IMiD) within 4 weeks prior to enrollment. A short course of corticosteroids is allowed prior to initiating the new line of induction therapy
Exclusion Criteria:
- Participant has plasma cell leukemia [greater than (>) 2.0 * 10^9 per liter] circulating plasma cells by standard differential), Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and/or skin changes), or amyloid light-chain amyloidosis
- Participant has a life expectancy of less than 6 months
- At the time of screening, participant is enrolled in an interventional clinical trial for multiple myeloma using an anti-neoplastic agent that is not currently approved by the United States (US) Food and Drug Administration (FDA) for this indication
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Sikander Ailawadhi, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available