Multiple Myeloma and Exercise

NCT ID: NCT01809717

Last Updated: 2020-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2013-08-31

Brief 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.

Detailed 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.

Conditions

Newly Diagnosed Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Weight Lifting Exercises

Group Type: EXPERIMENTAL

Weight Lifting Exercises

Intervention Type: OTHER

Interventions

Weight Lifting Exercises

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dan Vogl

Role: PRINCIPAL_INVESTIGATOR

Abramson CC

Locations

Abramson Cancer Center of the Unviersity of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

UPCC 13412

Identifier Type: -

Identifier Source: org_study_id