Multiple Myeloma and Exercise

March 9, 2020 updated by: Abramson Cancer Center of the University of Pennsylvania

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Abramson Cancer Center of the Unviersity of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Weight Lifting Exercises
Other: Weight Lifting Exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Adverse Events
Time Frame: 3-6 months
3-6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abramson Cancer Center of the University of Pennsylvania

Investigators

  • Principal Investigator: Dan Vogl, Abramson CC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

March 5, 2013

First Submitted That Met QC Criteria

March 11, 2013

First Posted (Estimate)

March 13, 2013

Study Record Updates

Last Update Posted (Actual)

March 10, 2020

Last Update Submitted That Met QC Criteria

March 9, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPCC 13412

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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