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Evaluation of Plerixafor (Mozobil ™, AMD3100) in Combination With Chemotherapy and G-CSF for CD34+ Cell Mobilization

Phase 2
18 Years
Open (Enrolling)
Myeloma, Lymphoma

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Trial Information

Evaluation of Plerixafor (Mozobil ™, AMD3100) in Combination With Chemotherapy and G-CSF for CD34+ Cell Mobilization

Study is ongoing; no interim analysis.

Inclusion Criteria:

1. Age 18-70 years

2. MM or NHL patients in first or second complete or partial remission

3. ECOG performance status of 0 or 1

4. Up to 3 prior treatment regimens

5. Meet all eligibility requirements for autologous transplant.

6. Adequate marrow function defined as WBC >3,000; ANC >1,500/mm3 ; Platelets

7. Adequate renal function defined as creatinine clearance > 30 mL/min by

8. Adequate liver function defined as AST/ALT/Bilirubin < 2 times upper limit of normal

9. Able to provide informed consent

10. Women not pregnant and agree to use contraception

Exclusion Criteria:

1. High risk co-morbidities for acute treatment complications (e.g., symptomatic
coronary artery disease)

2. Brain metastases or carcinomatous meningitis

3. Previous treatment with high dose chemotherapy and autologous transplant.

4. Previous attempt to collect B-HPCs following mobilization with growth factors alone,
growth factors and chemotherapy, or plerixafor and growth factors.

5. Acute infection or unexplained fever >38°C

6. Weight > 175% of ideal body weight as defined by the Devine equation.

7. Experimental therapy within 4 weeks

8. Cytokine administration in the previous 14 days

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of patients achieving the target number of either 5 x 106 (lymphoma) or 10 x 106 (myeloma) of CD34+ cells/kg in a single day of apheresis

Outcome Time Frame:

Within the first 4 days following the first dose of Plerixafor

Safety Issue:


Principal Investigator

Edmund Waller, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emory University Winship Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

March 2010

Completion Date:

November 2013

Related Keywords:

  • Myeloma
  • Lymphoma
  • Myeloma
  • Lymphoma
  • Stem cell transplantation
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Emory University Winship Cancer InstituteAtlanta, Georgia  30322