A randomized, double-blind, placebo-controlled, comparative trial of AMD3100 (240 mcg/kg) plus G-CSF (10 mcg/kg) versus G-CSF (10 mcg/kg) plus placebo to mobilize and collect greater than or equal to 6x10e6 CD34+ cells/kg in multiple myeloma patients for autologous transplantation - N/A
Phase 1
- Conditions
- Mobilization of stem cells prior to autologous stem cell transplantation in patients with multiple myelomaMedDRA version: 8.1Level: LLTClassification code 10028228Term: Multiple myeloma
- Registration Number
- EUCTR2005-003599-39-DE
- Lead Sponsor
- AnorMED Corp.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
*Diagnosis of multiple myeloma in first or second complete or partial remission
*ECOG performance status of 0 or 1
*White Blood Cell count (WBC) > 2.5 x 10e9/L
*Platelet (PLT) > 100 x 10e9/L
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
*Failed previous stem cell collection
*Previous stem cell transplantation
*Brain metastases or myelomatous meningitis
*Radiation to pelvis
*History of ventricular arrhythmias
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method