Trial Outcomes & Findings for A Randomized Study of the Site for Growth Factor Injection for Patients Undergoing Autologous Stem Cell Transplantation (NCT NCT00646763)

NCT ID: NCT00646763

Last Updated: 2025-04-01

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 35 participants
• Primary outcome timeframe: 4 days
• Results posted on: 2025-04-01

Participant Flow

Participant milestones

Measure	Abdomen These subjects will have their cytokine injections administered only to their abdomen.	Extremities The extremity arm will have their injections administered to their upper and/or lower extremities.
Overall Study STARTED	18	17
Overall Study COMPLETED	18	17
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Randomized Study of the Site for Growth Factor Injection for Patients Undergoing Autologous Stem Cell Transplantation

Baseline characteristics by cohort

Measure	Abdomen n=18 Participants These subjects will have their cytokine injections administered only to their abdomen.	Extremities n=17 Participants The extremity arm will have their injections administered to their upper and/or lower extremities.	Total n=35 Participants Total of all reporting groups
Age, Customized	53 Mean STANDARD_DEVIATION 13.76 • n=5 Participants	52 Mean STANDARD_DEVIATION 17.02 • n=7 Participants	53 Mean STANDARD_DEVIATION 15.21 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants	17 participants n=7 Participants	35 participants n=5 Participants
Disease type Lymphoma	4 participants n=5 Participants	6 participants n=7 Participants	10 participants n=5 Participants
Disease type Myeloma	14 participants n=5 Participants	11 participants n=7 Participants	25 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 days

Population: Patients at our institution between the ages of 18 and 70 years old with relapsed or refractory Hodgkin's disease, non-Hodgkin's lymphoma, or mutiple myelomawhowere scheduled for an autologous HSCTwere eligible to participate in the study.

Outcome measures

Measure	Abdomen n=18 Participants These subjects will have their cytokine injections administered only to their abdomen.	Extremities n=17 Participants The extremity arm will have their injections administered to their upper and/or lower extremities.
The Total Number of CD34+ Cells Collected.	9,150,000 cells per Kg Standard Deviation 4,700,000	9,850,000 cells per Kg Standard Deviation 4,970,000

PRIMARY outcome

Timeframe: 7 days

Target numbers of CD34+ cells for a single autologous transplant are typically at least 5.0 * 10^6 cells/kg, a cell dose that consistently results in rapid cell engraftment

Outcome measures

Measure	Abdomen n=18 Participants These subjects will have their cytokine injections administered only to their abdomen.	Extremities n=17 Participants The extremity arm will have their injections administered to their upper and/or lower extremities.
Number of Participants for Whom Target Number of CD34+ Cells Were Collected.	10 participants	9 participants

SECONDARY outcome

Timeframe: 7 days

the number of days of apheresis required to collect target numbers of CD34+ cells.

Outcome measures

Measure	Abdomen n=18 Participants These subjects will have their cytokine injections administered only to their abdomen.	Extremities n=17 Participants The extremity arm will have their injections administered to their upper and/or lower extremities.
Total Number of Days of Apheresis	2.18 days Standard Deviation 1.01	2.00 days Standard Deviation 0.97

Adverse Events

Abdomen

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Extremities

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Abdomen n=18 participants at risk These subjects will have their cytokine injections administered only to their abdomen.	Extremities n=17 participants at risk The extremity arm will have their injections administered to their upper and/or lower extremities.
Musculoskeletal and connective tissue disorders Bone Pain	100.0% 18/18	100.0% 17/17
Skin and subcutaneous tissue disorders Redness at the injection site	100.0% 18/18	100.0% 17/17

Additional Information

Edmund Waller, MD, PhD

Emory University Winship Cancer Institute

Phone: 1-888-946-7447

Email: ewaller@emory.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place