A Study to Explore Quality of Life According to Treatment Plan for Patients with Multiple Myeloma Following Autologous Stem Cell Transplant

Overview

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

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

Clinical Trials