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Status:

TERMINATED

Treatment With AMD3100 (Plerixafor) in MM Patients to Mobilize PBCs For Collection and for Transplantation

Lead Sponsor:

Genzyme, a Sanofi Company

Collaborating Sponsors:

AnorMED

Conditions:

Multiple Myeloma

Eligibility:

All Genders

18-75 years

Phase:

PHASE2

Brief Summary

This study will examine whether 240 µg/kg plerixafor given alone for up to 4 days is safe and well tolerated in multiple myeloma (MM) patients. In addition, this study determines if plerixafor alone c...

Detailed Description

This study will examine whether 240 µg/kg plerixafor given alone for up to 4 days is safe and well tolerated in multiple myeloma (MM) patients. In addition, this study determines if 240 µg/kg plerixaf...

Eligibility Criteria

Inclusion

  • Diagnosis of multiple myeloma (MM)
  • Eligible for autologous transplantation
  • Patients in first or second partial remission (PR) or complete remission (CR)
  • Patients who have received ≦2000 rads of prior radiation therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Recovered from all acute toxic effects of prior chemotherapy
  • White blood cells (WBC) \>3.0\*10\^9/l
  • Absolute polymorphonuclear leucocyte (PMN) count \>1.5\*10\^9/l
  • Platelet (PLT) count \> 150\*10\^9/l
  • Serum creatinine ≦2.2 mg/dl
  • Serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT) and total bilirubin \<2 x upper limit of normal (ULN)
  • Negative for HIV
  • Signed informed consent
  • Patients of childbearing potential agree to use an approved form of contraception

Exclusion

  • Patient received 2 or more alkylating agents, such as VBMCP (a combination of Vincristine, BCNU (Bis-Chloronitrosourea), Melphalan, Cyclophosphamide, and Prednisone)
  • Patient received a total dose of ≧200 mg of prior melphalan
  • A co-morbid condition which, in the view of the investigators, renders the patient at high risk from treatment complications
  • Patient has failed previous collections or collection attempts
  • A residual acute medical condition resulting from prior chemotherapy
  • Brain metastases or carcinomatous meningitis
  • Acute infection
  • Fever (temperature \>38 °C / 100.4 °F)
  • Hypercalcemia (\>1mg/dl above ULN)
  • Positive pregnancy test in female patients
  • Lactating females
  • Patients of childbearing potential unwilling to implement adequate birth control
  • Patients whose actual body weight exceeds 175% of their ideal body weight
  • History of ventricular arrhythmias
  • Patient received thalidomide within 10 days prior to receiving the first dose of plerixafor
  • Patients who previously received experimental therapy within 4 weeks of enrolling in this protocol or who are currently enrolled in another experimental protocol during the mobilization phase

Key Trial Info

Start Date :

November 1 2004

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2007

Estimated Enrollment :

9 Patients enrolled

Trial Details

Trial ID

NCT00396383

Start Date

November 1 2004

End Date

May 1 2007

Last Update

March 13 2014

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Memorial Sloan-Kettering Cancer Center

New York, New York, United States, 10021

2

Thomas Jefferson University

Philadelphia, Pennsylvania, United States, 19107