Trial Outcomes & Findings for Filgrastim With or Without Plerixafor in Treating Patients With Multiple Myeloma Previously Treated With Lenalidomide (NCT NCT01301963)

NCT ID: NCT01301963

Last Updated: 2014-08-06

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

9 participants

Primary outcome timeframe

In =< 2 days of leukaphereses

Results posted on

2014-08-06

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I: Control Patients receive G-CSF SC QD on days 1-4. filgrastim: Given SC	Arm II: Experimental Patients receive G-CSF SC QD on days 1-4 and plerixafor SC QD on days 4-8. plerixafor: Given SC filgrastim: Given SC
Overall Study STARTED	5	4
Overall Study COMPLETED	5	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Filgrastim With or Without Plerixafor in Treating Patients With Multiple Myeloma Previously Treated With Lenalidomide

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I n=5 Participants Patients receive G-CSF SC QD on days 1-4. filgrastim: Given SC	Arm II n=4 Participants Patients receive G-CSF SC QD on days 1-4 and plerixafor SC QD on days 4-8. plerixafor: Given SC filgrastim: Given SC	Total n=9 Participants Total of all reporting groups
Age, Continuous	52.40 years STANDARD_DEVIATION 4.16 • n=5 Participants	56.25 years STANDARD_DEVIATION 8.18 • n=7 Participants	53.00 years STANDARD_DEVIATION 6.15 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	4 participants n=7 Participants	9 participants n=5 Participants

PRIMARY outcome

Timeframe: In =< 2 days of leukaphereses

Population: due to low enrollment (10% of anticipated participants), no analysis is being done on data collected in this study

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: In =< 5 days of leukaphereses

Population: Due to low enrollment (10% of anticipated participants), no analysis is being done on data collected in this study

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: By day 1

Patients will be randomized to receive either G-CSF or Plerixafor with G-CSF. All patients will undergo at least 2 days of leukopheresis. Cells/kg between these 2 arms will be compared. For those patients that do not reach the target goal will undergo a wash-out period and cross over to the other study arm.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1

Using the Wilcoxon Rand Sum Test

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1

Using the Chi-square test or Fisher's exact test, as appropriate.

Outcome measures

Outcome data not reported

Adverse Events

Arm I: Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm II: Experimental

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Hien Duong, MD

CCCC

Phone: 216-445-5531

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place