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Open Label Phase II Trial of an Augmented Mobilization Strategy With Plerixafor (Mozobil®) in a Population at Risk for Poor Stem Cell Mobilization


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma, Lymphoma

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Trial Information

Open Label Phase II Trial of an Augmented Mobilization Strategy With Plerixafor (Mozobil®) in a Population at Risk for Poor Stem Cell Mobilization


Inclusion Criteria:



1. Participants must be 18 years of age or older

2. Patients must be able to provide written consent

3. Participants must have a diagnosis of lymphoma or multiple myeloma and be undergoing
autologous stem cell mobilization for the purposes of ASCT

4. Females of child bearing age will be asked to use an approved form of contraception

Exclusion Criteria:

1. Patients who are pregnant or breastfeeding

2. Patients whose creatinine ≥ 250 μM

3. Serum AST, ALT or total bilirubin >5X upper limit of normal

4. Acute infection

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To increase the proportion of Poor Mobilizers who after receiving plerixafor are successfully collected in one day. The anticipated proportion increase is from 30%-60%.

Outcome Time Frame:

within 1-2 days after commencing therapy

Safety Issue:

No

Authority:

Canada: Health Canada

Study ID:

CCM-002

NCT ID:

NCT01037517

Start Date:

January 2010

Completion Date:

February 2013

Related Keywords:

  • Multiple Myeloma
  • Lymphoma
  • Myeloma
  • Multiple Myeloma or Lymphoma Patients undergoing
  • mobilization for the purpose of autologous stem cell collection
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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