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Multiple Myeloma and Exercise

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ClinicalTrials.gov Identifier: NCT01809717
Recruitment Status : Completed
First Posted : March 13, 2013
Last Update Posted : October 13, 2014
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Newly Diagnosed Multiple Myeloma Other: Weight Lifting Exercises Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Modulating The Toxicity And Efficacy Of High Dose Chemotherapy For Multiple Myeloma Through An Intervention To Increase Lean Body Mass
Study Start Date : March 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013


Arm Intervention/treatment
Experimental: Weight Lifting Exercises Other: Weight Lifting Exercises



Primary Outcome Measures :
  1. Number of Adverse Events [ Time Frame: 3-6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01809717


Locations
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United States, Pennsylvania
Abramson Cancer Center of the Unviersity of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania

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Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01809717     History of Changes
Other Study ID Numbers: UPCC 13412
First Posted: March 13, 2013    Key Record Dates
Last Update Posted: October 13, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases