NCT01809717

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 13, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

March 10, 2020

Status Verified

March 1, 2020

Enrollment Period

5 months

First QC Date

March 5, 2013

Last Update Submit

March 9, 2020

Conditions

Newly Diagnosed Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

  • Number of Adverse Events

    3-6 months

Study Arms (1)

Weight Lifting Exercises

EXPERIMENTAL
Other: Weight Lifting Exercises

Interventions

Weight Lifting ExercisesOTHER
Weight Lifting Exercises

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed multiple myeloma
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abramson Cancer Center of the Unviersity of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Study Officials

  • Dan Vogl

    Abramson CC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2013

First Posted

March 13, 2013

Study Start

March 1, 2013

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

March 10, 2020

Record last verified: 2020-03

Locations

US(1)