Trial Outcomes & Findings for UARK 2003-25: A Study of Intravenous (IV) Busulfan (Busulfex®) in Multiple Myeloma Patients (NCT NCT00113919)

Last Updated: 2017-10-16

Results Overview

maximal dose of Busulfex® that can be given in a two, three, or four day period with acceptable toxicity to myeloma patients, who either are \> or = 65 years of age or have renal insufficiency, defined as creatinine \> 3g/dL or creatinine clearance \< 30 ml/min

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

14 participants

Primary outcome timeframe

three years

Results posted on

2017-10-16

Participant Flow

This study was conducted at a medical facility. The subjects were recruited from the physician's patient base.

Participant milestones

Participant milestones
Measure	Bisulfan Bisulfan in Multiple Myeloma patients \>65 years w/renal insufficiency
Overall Study STARTED	14
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Bisulfan Bisulfan in Multiple Myeloma patients \>65 years w/renal insufficiency
Overall Study Physician Decision	8
Overall Study Death	6

Baseline Characteristics

UARK 2003-25: A Study of Intravenous (IV) Busulfan (Busulfex®) in Multiple Myeloma Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bisulfan n=14 Participants Bisulfan in Multiple Myeloma patients \>65 years w/renal insufficiency
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: three years

Outcome measures

Outcome data not reported

Adverse Events

Bisulfan

Serious events: 12 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Bisulfan n=14 participants at risk Bisulfan in Multiple Myeloma patients \>65 years w/renal insufficiency
Blood and lymphatic system disorders Deep Vein Thrombosis	7.1% 1/14 • Number of events 1 • Dependent on notification by patient. Once UAMS received notification, documentation submitted to IRB within one week.
Gastrointestinal disorders abdominal pain	7.1% 1/14 • Number of events 1 • Dependent on notification by patient. Once UAMS received notification, documentation submitted to IRB within one week.
General disorders acute respiratory distress due to fluid overload	14.3% 2/14 • Number of events 2 • Dependent on notification by patient. Once UAMS received notification, documentation submitted to IRB within one week.
Infections and infestations bacteremia	7.1% 1/14 • Number of events 1 • Dependent on notification by patient. Once UAMS received notification, documentation submitted to IRB within one week.
Blood and lymphatic system disorders blood clot in Arteriovenous fistula	7.1% 1/14 • Number of events 1 • Dependent on notification by patient. Once UAMS received notification, documentation submitted to IRB within one week.
General disorders catheter related septecemia	7.1% 1/14 • Number of events 1 • Dependent on notification by patient. Once UAMS received notification, documentation submitted to IRB within one week.
General disorders cholecystitis	7.1% 1/14 • Number of events 1 • Dependent on notification by patient. Once UAMS received notification, documentation submitted to IRB within one week.
Gastrointestinal disorders colitis, diarrhea	7.1% 1/14 • Number of events 1 • Dependent on notification by patient. Once UAMS received notification, documentation submitted to IRB within one week.
Cardiac disorders febrile neutropenia with hypotention	7.1% 1/14 • Number of events 1 • Dependent on notification by patient. Once UAMS received notification, documentation submitted to IRB within one week.
General disorders fluid overload	14.3% 2/14 • Number of events 2 • Dependent on notification by patient. Once UAMS received notification, documentation submitted to IRB within one week.
General disorders hypotension, edema and depression	7.1% 1/14 • Number of events 1 • Dependent on notification by patient. Once UAMS received notification, documentation submitted to IRB within one week.
General disorders hypovolemic shock	7.1% 1/14 • Number of events 1 • Dependent on notification by patient. Once UAMS received notification, documentation submitted to IRB within one week.
General disorders inflammation syndrome, cellulitis, pansinusitis	7.1% 1/14 • Number of events 1 • Dependent on notification by patient. Once UAMS received notification, documentation submitted to IRB within one week.
General disorders nephrogenic fibrosing dermopathy	7.1% 1/14 • Number of events 1 • Dependent on notification by patient. Once UAMS received notification, documentation submitted to IRB within one week.
General disorders pancytopenia	7.1% 1/14 • Number of events 1 • Dependent on notification by patient. Once UAMS received notification, documentation submitted to IRB within one week.
Gastrointestinal disorders renal failure	21.4% 3/14 • Number of events 3 • Dependent on notification by patient. Once UAMS received notification, documentation submitted to IRB within one week.
General disorders seizures	14.3% 2/14 • Number of events 2 • Dependent on notification by patient. Once UAMS received notification, documentation submitted to IRB within one week.
General disorders septic shock	7.1% 1/14 • Number of events 1 • Dependent on notification by patient. Once UAMS received notification, documentation submitted to IRB within one week.
Cardiac disorders shortness of breath and tachcardia	7.1% 1/14 • Number of events 1 • Dependent on notification by patient. Once UAMS received notification, documentation submitted to IRB within one week.
General disorders staphylococcal infection	7.1% 1/14 • Number of events 1 • Dependent on notification by patient. Once UAMS received notification, documentation submitted to IRB within one week.

Other adverse events

Adverse event data not reported

Additional Information

Nathan Petty

University of Arkansas for Medical Sciences

Phone: 501-837-3894

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place