Modulating The Toxicity And Efficacy Of High Dose Chemotherapy For Multiple Myeloma Through An Intervention To Increase Lean Body Mass
18 Years
N/A
Both
Newly Diagnosed Multiple Myeloma
Trial Information
Modulating The Toxicity And Efficacy Of High Dose Chemotherapy For Multiple Myeloma Through An Intervention To Increase Lean Body Mass
This is a prospective, single-institution, pilot study of a 3 month weight lifting program
designed to increase musle hypertrophy prior to starting stem cell collection and receiving
high-dose melphalan, in patients with multiple myeloma. We will use this exercise
intervention while patients are receiving initial induction chemotherapy in the 3-6 month
period before they receiv high-dose melphalan. The primary study endpoint is to determine
the feasibility of recruiting and retaining multiple myeloma patients to an exercise
intervention trial. The secondary study endpoint is to determine whether the weight lifting
program increases lean body mass as intended.
Inclusion Criteria:
- Histologically confirmed multiple myeloma
- 1 year since start of treatment for myeloma
- Patient and treating physician in agreement to proceed with autologous transplant,
with a planned time betwwen study enrollment and transplant of 10 weeks
- Age 18 years.
- Able to walk for 6 minutes unaided.
- Body mass index 50 kg/m2
- Serum creatinine 2.5 mg/dL
- Ability to understand the informed consent document and willingness to consent.
Written informed consent must be obtained from all patients before study entry.
Exclusion Criteria:
- Recent (in the past 6 months) participation in progressive weight lifting exercises
or who already exercise regulary (3 times a week of moderate intensity aerobic
exercise).
- Plan to move out of the area during the study intervention.
- A psychological, social, or logistical barrier that the principal investigators feel
would preclude completion of the study protocol.
- Plan for use of any anti-myeloma treatment other than melphalan (the use of total
body irradiation will NOT
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Number of Adverse Events
Outcome Time Frame:
3-6 months
Safety Issue:
Yes
Authority:
United States: Institutional Review Board
Study ID:
UPCC 13412
NCT ID:
NCT01809717
Start Date:
March 2013
Completion Date:
March 2014
Related Keywords:
- Newly Diagnosed Multiple Myeloma
- Multiple Myeloma
- Neoplasms, Plasma Cell
Name | Location |
|---|---|
| Abramson Cancer Center of the Unviersity of Pennsylvania | Philadelphia, Pennsylvania 19104 |
