Multiple Myeloma and Exercise

Newly Diagnosed Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01809717
• Other study ID #: UPCC 13412
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: August 2013

Study information

• Verified date: March 2020
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will establich the feasibility of weight lifting exercise among patients with multiple myeloma, determine if weight lifting exercise increases lean body mass among patients with multiple myeloma and obtain further preliminary data on toxicity and pharmacokinetics of high-dose melphalan.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Newly Diagnosed Multiple Myeloma

Intervention

Other:
• Weight Lifting Exercises

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the Unviersity of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Adverse Events		3-6 months