A Study to Explore Quality of Life According to Treatment Plan for Patients with Multiple Myeloma Following Autologous Stem Cell Transplant
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
- Rochester, Minnesota: 16-007208
Sponsor Protocol Number: MRS-MM-REV-USA-071020151
About this study
The purpose of this study is to understand more about how multiple myeloma and its treatment affect day-to-day life for patients, with particular interest in how life is affected following stem cell transplant.
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
- Voluntarily sign an informed consent form
- Age ≥18 years
- Has initial diagnosis of multiple myeloma, and has had Stem Cell Transplant as treatment
- Monoclonal plasma cells in bone marrow ≥10% and/or presence of biopsy-proven plasmacytoma
- Monoclonal protein present in serum and/or urine.
- Myeloma-related organ dysfunction 1 or more
- (C) Calcium elevation in blood
- Serum calcium >1mg/dL (>0.25mmol/L) higher than the upper limit of normal or >11mg/dL (>2.75mmol/L)
- (R) Renal insufficiency
- SCr >2 mg/dL or >177 μmol/L)
- (A) Anemia
- Hemoglobin <10 g/dL (< 100g/L) or >2g/dL (>20g/L) below normal
- (B) Lytic bone lesions or osteoporosis
- Has received induction therapy followed by a single autologous stem cell transplant and should fall into one of the following subgroups
- Immediately following transplant (within the last 30-100 days) and has not yet commenced maintenance therapy,but previously received induction therapy
- Should not have experienced clinical progression post transplant
- > 100 days post stem cell transplant and currently receiving lenalidomide monotherapy as maintenance therapy
- Should not have experienced clinical progression post transplant
- > 100 days post stem cell transplant and currently receiving treatment that is not lenalidomide monotherapy as maintenance therapy (can include lenalidomide as combination therapy)
- Should not have experienced clinical progression post transplant
- > 100 days post stem cell transplant and currently not receiving any maintenance therapy following induction therapy
- Should not have experienced clinical progression post transplant
- > 100 days post stem cell transplant and has been informed they have progressive disease
- Should not yet have initiated the next line of treatment irrespective of whether has previously received maintenance therapy
Exclusion Criteria
- Allogeneic transplant
- Non-transplant
- Pre-transplant
- Tandem transplant
- Further transplant (history of >1 stem cell transplant)
- Has received consolidation therapy
- Current involvement in a clinical trial which prohibits participation in other research
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 |
|
Rochester, Minn.
Mayo Clinic principal investigator Shaji Kumar, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available