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Modulating The Toxicity And Efficacy Of High Dose Chemotherapy For Multiple Myeloma Through An Intervention To Increase Lean Body Mass


N/A
18 Years
N/A
Open (Enrolling)
Both
Newly Diagnosed Multiple Myeloma

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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 PennsylvaniaPhiladelphia, Pennsylvania  19104