Trial Outcomes & Findings for FM 140 vs FM100 Study in Patients With Multiple Myeloma (NCT NCT00505895)

NCT ID: NCT00505895

Last Updated: 2014-10-17

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

52 participants

Primary outcome timeframe

Day 100

Results posted on

2014-10-17

Participant Flow

Recruitment Period: January 18, 2002 to July 27, 2011. All recruitment done in a medical clinical setting.

Of the 52 participants enrolled, two were not included due to one patient experiencing pulmonary complication and another not completing the study follow up requirement.

Participant milestones

Participant milestones
Measure	Fludarabine + Melphalan + Stem Cell Infusion Fludarabine 30 mg/m\^2 intravenous (IV) daily over 30 minutes for 4 Days (Beginning Day -4). Melphalan 140 mg/m\^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m\^2 IV infused starting on day -5.	Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion Fludarabine 30 mg/m\^2 IV daily over 30 minutes for 4 Days (Beginning Day -4). Lower-Dose Melphalan 100 mg/m\^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m\^2 IV infused starting on day -5.
Overall Study STARTED	27	23
Overall Study COMPLETED	27	23
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

FM 140 vs FM100 Study in Patients With Multiple Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fludarabine + Melphalan + Stem Cell Infusion n=27 Participants Fludarabine 30 mg/m\^2 intravenous (IV) daily over 30 minutes for 4 Days (Beginning Day -4). Melphalan 140 mg/m\^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m\^2 IV infused starting on day -5.	Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion n=23 Participants Fludarabine 30 mg/m\^2 intravenous daily over 30 minutes for 4 Days (Beginning Day -4). Lower-Dose Melphalan 100 mg/m\^2 intravenous over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m\^2 intravenous infused starting on day -5.	Total n=50 Participants Total of all reporting groups
Age, Continuous	52 years n=5 Participants	53 years n=7 Participants	53 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	12 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	11 Participants n=7 Participants	30 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants	23 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 100

Outcome measures

Outcome measures
Measure	Fludarabine + Melphalan + Stem Cell Infusion n=27 Participants Fludarabine 30 mg/m\^2 intravenous (IV) daily over 30 minutes for 4 Days (Beginning Day -4). Melphalan 140 mg/m\^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m\^2 IV infused starting on day -5.	Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion n=23 Participants Fludarabine 30 mg/m\^2 IV daily over 30 minutes for 4 Days (Beginning Day -4). Lower-Dose Melphalan 100 mg/m\^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m\^2 IV infused starting on day -5.
Number of Participants With Successful Engraftment at Day 100	27 participants	23 participants

SECONDARY outcome

Timeframe: GVHD grading weekly during first 100 days; Annual examinations for nine year study period

Population: For the acute GVHD analysis, only 48 patients' data were available.

Effects of Rituximab as measured by percentage of participants with Acute and Chronic Graft Versus Host Disease (GVHD) incidences after allogeneic transplantation. GVHD occurring anytime after day 90 post transplant was considered chronic GVHD; otherwise it was considered acute GVHD. Acute GVHD status defined as GVHD with maximum grade ≥2. Clinical grading of Acute GVHD (Thomas et al., New England Journal of Medicine (NEJM), 229:895, 1975): Grade 1 to 4.

Outcome measures

Outcome measures
Measure	Fludarabine + Melphalan + Stem Cell Infusion n=27 Participants Fludarabine 30 mg/m\^2 intravenous (IV) daily over 30 minutes for 4 Days (Beginning Day -4). Melphalan 140 mg/m\^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m\^2 IV infused starting on day -5.	Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion n=23 Participants Fludarabine 30 mg/m\^2 IV daily over 30 minutes for 4 Days (Beginning Day -4). Lower-Dose Melphalan 100 mg/m\^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m\^2 IV infused starting on day -5.
Acute Grade II-IV Graft Versus Host Disease (GVHD) Chronic GVHD	29 percentage of participants	48 percentage of participants
Acute Grade II-IV Graft Versus Host Disease (GVHD) Acute GVHD	22 percentage of participants	21 percentage of participants

Adverse Events

Fludarabine + Melphalan + Stem Cell Infusion

Serious events: 23 serious events

Other events: 8 other events

Deaths: 0 deaths

Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion

Serious events: 16 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Fludarabine + Melphalan + Stem Cell Infusion n=27 participants at risk Fludarabine 30 mg/m\^2 intravenous (IV) daily over 30 minutes for 4 Days (Beginning Day -4). Melphalan 140 mg/m\^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m\^2 IV infused starting on day -5.	Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion n=23 participants at risk Fludarabine 30 mg/m\^2 IV daily over 30 minutes for 4 Days (Beginning Day -4). Lower-Dose Melphalan 100 mg/m\^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m\^2 IV infused starting on day -5.
General disorders Death	85.2% 23/27 • Number of events 23 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.	69.6% 16/23 • Number of events 16 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.
Gastrointestinal disorders Diarrhea	7.4% 2/27 • Number of events 2 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.	0.00% 0/23 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.
Investigations Infection	11.1% 3/27 • Number of events 5 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.	26.1% 6/23 • Number of events 14 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.
Respiratory, thoracic and mediastinal disorders Pneumonitis	7.4% 2/27 • Number of events 2 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.	4.3% 1/23 • Number of events 1 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.
Nervous system disorders Seizures	3.7% 1/27 • Number of events 1 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.	0.00% 0/23 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.
Metabolism and nutrition disorders Total Bilirubin Level Change	7.4% 2/27 • Number of events 2 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.	0.00% 0/23 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.
Blood and lymphatic system disorders Secondary graft failure	0.00% 0/27 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.	4.3% 1/23 • Number of events 1 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.
Skin and subcutaneous tissue disorders Rash	0.00% 0/27 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.	4.3% 1/23 • Number of events 1 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.
Nervous system disorders Altered mental status	0.00% 0/27 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.	4.3% 1/23 • Number of events 1 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.
Renal and urinary disorders Elevated creatinine	0.00% 0/27 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.	4.3% 1/23 • Number of events 1 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.
Respiratory, thoracic and mediastinal disorders Pulmonary hemorrhage	3.7% 1/27 • Number of events 1 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.	0.00% 0/23 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.
Hepatobiliary disorders Elevated ALT	3.7% 1/27 • Number of events 1 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.	0.00% 0/23 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.
Gastrointestinal disorders Dysphagia	3.7% 1/27 • Number of events 1 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.	0.00% 0/23 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.

Other adverse events

Additional Information

Muzaffar Qazilbash, MD / Professor, Stem Cell Transplantation

University of Texas MD Anderson Cancer Center

Phone: 713-745-4371

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Fludarabine + Melphalan + Stem Cell Infusion n=27 participants at risk Fludarabine 30 mg/m\^2 intravenous (IV) daily over 30 minutes for 4 Days (Beginning Day -4). Melphalan 140 mg/m\^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m\^2 IV infused starting on day -5.	Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion n=23 participants at risk Fludarabine 30 mg/m\^2 IV daily over 30 minutes for 4 Days (Beginning Day -4). Lower-Dose Melphalan 100 mg/m\^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m\^2 IV infused starting on day -5.
Infections and infestations Fever	11.1% 3/27 • Number of events 3 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.	13.0% 3/23 • Number of events 3 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.
General disorders Volume overload	3.7% 1/27 • Number of events 1 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.	13.0% 3/23 • Number of events 3 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.
Cardiac disorders Hypertension	3.7% 1/27 • Number of events 1 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.	4.3% 1/23 • Number of events 1 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.
Gastrointestinal disorders Diarrhea	18.5% 5/27 • Number of events 5 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.	26.1% 6/23 • Number of events 6 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.
Gastrointestinal disorders Dysphagia	11.1% 3/27 • Number of events 3 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.	21.7% 5/23 • Number of events 5 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.
Gastrointestinal disorders Nausea	25.9% 7/27 • Number of events 8 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.	43.5% 10/23 • Number of events 11 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.
Skin and subcutaneous tissue disorders Rash	7.4% 2/27 • Number of events 3 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.	13.0% 3/23 • Number of events 3 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.
Nervous system disorders Dizziness	3.7% 1/27 • Number of events 1 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.	4.3% 1/23 • Number of events 1 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.
Renal and urinary disorders Hematuria	3.7% 1/27 • Number of events 1 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.	4.3% 1/23 • Number of events 1 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.
Renal and urinary disorders Elevated Creatinine	3.7% 1/27 • Number of events 1 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.	4.3% 1/23 • Number of events 1 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.
Eye disorders Conjunctivitis	3.7% 1/27 • Number of events 1 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.	8.7% 2/23 • Number of events 2 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.
Infections and infestations Infection	7.4% 2/27 • Number of events 2 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.	8.7% 2/23 • Number of events 3 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.
Cardiac disorders Dysarrhythmia	0.00% 0/27 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.	4.3% 1/23 • Number of events 1 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.
Hepatobiliary disorders Elevated Alkaline Phosphatase	0.00% 0/27 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.	8.7% 2/23 • Number of events 2 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.
Hepatobiliary disorders Elevated ALT	0.00% 0/27 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.	8.7% 2/23 • Number of events 2 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.
General disorders Lethargy	0.00% 0/27 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.	4.3% 1/23 • Number of events 1 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.
Nervous system disorders Neuropathy	0.00% 0/27 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.	4.3% 1/23 • Number of events 1 • The end of active treatment was the day of the drug administration of Rituximab on Day+16. Study participation was from baseline to 100 days after transplantation. Overall study period was March 2002 to May 2013.