Trial Outcomes & Findings for Busulfan Plus Melphalan Conditioning Regimen for Lymphoid Malignancies or Multiple Myeloma (NCT NCT00427765)
NCT ID: NCT00427765
Last Updated: 2012-01-19
Results Overview
Average number of years for survival post transplant where overall survival time is measured from date of transplant to disease progression or death for any reason.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
168 participants
Primary outcome timeframe
Baseline(transplantation) to disease progression or death for any reason, up to 6 years.
Results posted on
2012-01-19
Participant Flow
Recruitment Period: 2/4/2005 through 10/29/2010. All participant recruitment attempted at UT MD Anderson Cancer Center.
Among the participants enrolled, two were excluded from the trial before starting any treatment. There are two participants who were enrolled on the study twice (having to temporarily leave then re-enter the study).
Participant milestones
| Measure |
Busulfan + Melphalan
Busulfan 32 mg/m\^2 intravenous (IV) for 1 Day then 130 mg/m\^2 IV for 4 Days; and Melphalan 70 mg/m\^2 IV for 2 Days
|
|---|---|
|
Overall Study
STARTED
|
164
|
|
Overall Study
COMPLETED
|
164
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Busulfan Plus Melphalan Conditioning Regimen for Lymphoid Malignancies or Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Busulfan + Melphalan
n=164 Participants
Busulfan 32 mg/m\^2 intravenous (IV) for 1 Day then 130 mg/m\^2 IV for 4 Days; and Melphalan 70 mg/m\^2 IV for 2 Days
|
|---|---|
|
Age Continuous
|
42 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
97 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
164 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline(transplantation) to disease progression or death for any reason, up to 6 years.Population: Analysis by protocol
Average number of years for survival post transplant where overall survival time is measured from date of transplant to disease progression or death for any reason.
Outcome measures
| Measure |
Busulfan + Melphalan
n=164 Participants
Busulfan 32 mg/m\^2 intravenous (IV) for 1 Day then 130 mg/m\^2 IV for 4 Days; and Melphalan 70 mg/m\^2 IV for 2 Days
|
|---|---|
|
Average Overall Survival Time
|
3 years
Interval 0.1 to 6.0
|
Adverse Events
Busulfan + Melphalan
Serious events: 31 serious events
Other events: 164 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Busulfan + Melphalan
n=164 participants at risk
Busulfan 32 mg/m\^2 intravenous (IV) for 1 Day then 130 mg/m\^2 IV for 4 Days; and Melphalan 70 mg/m\^2 IV for 2 Days
|
|---|---|
|
Renal and urinary disorders
Acute Renal Failure
|
1.8%
3/164 • Number of events 3 • 5 years and 9 months
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
0.61%
1/164 • Number of events 1 • 5 years and 9 months
|
|
General disorders
Cholecystitis
|
0.61%
1/164 • Number of events 1 • 5 years and 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Diffuse Alveolar Hemorrhage
|
1.8%
3/164 • Number of events 3 • 5 years and 9 months
|
|
General disorders
Graft Vs Host Disease
|
5.5%
9/164 • Number of events 9 • 5 years and 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.2%
2/164 • Number of events 2 • 5 years and 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.61%
1/164 • Number of events 1 • 5 years and 9 months
|
|
General disorders
Ascites
|
0.61%
1/164 • Number of events 1 • 5 years and 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
1.8%
3/164 • Number of events 3 • 5 years and 9 months
|
|
Infections and infestations
Infection/Sepsis
|
1.2%
2/164 • Number of events 2 • 5 years and 9 months
|
|
Hepatobiliary disorders
Veno-Occlusive Disease
|
0.61%
1/164 • Number of events 1 • 5 years and 9 months
|
|
General disorders
Graft Failure
|
0.61%
1/164 • Number of events 1 • 5 years and 9 months
|
|
Gastrointestinal disorders
Esophagitis
|
0.61%
1/164 • Number of events 1 • 5 years and 9 months
|
|
Gastrointestinal disorders
Gastritis
|
0.61%
1/164 • Number of events 1 • 5 years and 9 months
|
|
General disorders
Portal Vein Flow
|
0.61%
1/164 • Number of events 1 • 5 years and 9 months
|
Other adverse events
| Measure |
Busulfan + Melphalan
n=164 participants at risk
Busulfan 32 mg/m\^2 intravenous (IV) for 1 Day then 130 mg/m\^2 IV for 4 Days; and Melphalan 70 mg/m\^2 IV for 2 Days
|
|---|---|
|
Cardiac disorders
Dysrhythmia
|
0.61%
1/164 • Number of events 1 • 5 years and 9 months
|
|
Cardiac disorders
Edema
|
1.2%
2/164 • Number of events 2 • 5 years and 9 months
|
|
Cardiac disorders
Hypertension
|
1.8%
3/164 • Number of events 3 • 5 years and 9 months
|
|
Blood and lymphatic system disorders
Thrombotic Thrombocytopenic purpura
|
1.2%
2/164 • Number of events 2 • 5 years and 9 months
|
|
General disorders
Fever
|
9.8%
16/164 • Number of events 16 • 5 years and 9 months
|
|
Gastrointestinal disorders
Diarrhea
|
67.1%
110/164 • Number of events 110 • 5 years and 9 months
|
|
Gastrointestinal disorders
Mucositis
|
84.1%
138/164 • Number of events 138 • 5 years and 9 months
|
|
Gastrointestinal disorders
Nausea
|
95.1%
156/164 • Number of events 156 • 5 years and 9 months
|
|
Renal and urinary disorders
Elevated Creatinine
|
2.4%
4/164 • Number of events 4 • 5 years and 9 months
|
|
Renal and urinary disorders
Hemorrhagic Cystitis
|
9.8%
16/164 • Number of events 16 • 5 years and 9 months
|
|
Hepatobiliary disorders
Elevated Alkaline Phosphatase
|
1.8%
3/164 • Number of events 3 • 5 years and 9 months
|
|
Hepatobiliary disorders
Elevated Alanine Aminotransferase
|
2.4%
4/164 • Number of events 4 • 5 years and 9 months
|
|
Hepatobiliary disorders
Elevated Bilirubin
|
6.7%
11/164 • Number of events 11 • 5 years and 9 months
|
|
Hepatobiliary disorders
Veno-Occlusive Disease
|
1.8%
3/164 • Number of events 3 • 5 years and 9 months
|
|
Infections and infestations
Infections
|
42.7%
70/164 • Number of events 70 • 5 years and 9 months
|
|
General disorders
Neutropenic Fever
|
43.9%
72/164 • Number of events 72 • 5 years and 9 months
|
|
General disorders
Confusion
|
1.8%
3/164 • Number of events 3 • 5 years and 9 months
|
|
General disorders
Headache
|
1.8%
3/164 • Number of events 3 • 5 years and 9 months
|
|
Nervous system disorders
Guillain-Barre Syndrome
|
0.61%
1/164 • Number of events 1 • 5 years and 9 months
|
|
Nervous system disorders
Cranial Nerve Palsy
|
1.2%
2/164 • Number of events 2 • 5 years and 9 months
|
|
Nervous system disorders
Seizure
|
1.2%
2/164 • Number of events 2 • 5 years and 9 months
|
|
Nervous system disorders
Neuropathy
|
1.8%
3/164 • Number of events 3 • 5 years and 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hemorrhage
|
0.61%
1/164 • Number of events 1 • 5 years and 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
7.3%
12/164 • Number of events 12 • 5 years and 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
2.4%
4/164 • Number of events 4 • 5 years and 9 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.9%
13/164 • Number of events 13 • 5 years and 9 months
|
|
General disorders
Graft Vs Host Disease
|
29.3%
48/164 • Number of events 48 • 5 years and 9 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place