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Multiple Myeloma and Exercise

Primary Purpose

Newly Diagnosed Multiple Myeloma

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Weight Lifting Exercises

About this trial

This is an interventional prevention trial for Newly Diagnosed Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Abramson Cancer Center of the Unviersity of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Weight Lifting Exercises

Arm Description

Outcomes

Primary Outcome Measures

Number of Adverse Events

Secondary Outcome Measures

Full Information

NCT ID

NCT01809717

First Posted

March 5, 2013

Last Updated

March 9, 2020

Sponsor

Abramson Cancer Center at Penn Medicine

1. Study Identification

Unique Protocol Identification Number

NCT01809717

Brief Title

Multiple Myeloma and Exercise

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

March 2013 (undefined)

Primary Completion Date

August 2013 (Actual)

Study Completion Date

August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Abramson Cancer Center at Penn Medicine

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Newly Diagnosed Multiple Myeloma

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Weight Lifting Exercises

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

Weight Lifting Exercises

Primary Outcome Measure Information:

Title

Number of Adverse Events

Time Frame

3-6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dan Vogl

Organizational Affiliation

Abramson CC

Official's Role

Principal Investigator

Facility Information:

Facility Name

Abramson Cancer Center of the Unviersity of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

12. IPD Sharing Statement

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Multiple Myeloma and Exercise

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