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WCI1680-09: Evaluation of Alterations in Time of Administration of Plerixafor (Mozobil ®, AMD3100) in Combination With G-CSF on Safety and CD34+ Cell Mobilization


Phase 2
18 Years
N/A
Not Enrolling
Both
Autologous Transplantation

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Trial Information

WCI1680-09: Evaluation of Alterations in Time of Administration of Plerixafor (Mozobil ®, AMD3100) in Combination With G-CSF on Safety and CD34+ Cell Mobilization


Inclusion Criteria:



1. Age 18-70 years

2. MM 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
>75,000/mm3

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

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:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the proportion of patients who collect ≥ 5 x 106 CD34+ cells by day 5 (4 apheresis sessions) with plerixafor administration at 1500 and compare to historical data with administration at 2200.

Outcome Time Frame:

Within the first 5 days following plerixafor initiation

Safety Issue:

No

Principal Investigator

R. Donald Harvey, PharmD, FCCP

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emory University Winship Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

WCI1680-09

NCT ID:

NCT01149863

Start Date:

June 2010

Completion Date:

Related Keywords:

  • Autologous Transplantation
  • Autologous Transplantation

Name

Location

Emory University Winship Cancer InstituteAtlanta, Georgia  30322