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Completed

NCT Number: NCT01809717

Multiple Myeloma and Exercise

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Abramson Cancer Center of the Unviersity of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Weight Lifting Exercises

Other

Primary outcomes

  1. Number of Adverse Events

    Time frame: 3-6 months

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Mar 13, 2013
Registry last updated
Mar 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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