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

NCT ID: NCT00396383

Last Updated: 2014-03-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-11-30
• Study Completion Date: 2007-05-31

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 can be used to mobilize peripheral blood progenitor cells (PBPCs) for transplantation in MM patients. The minimum number of CD34+ cells to collect is 2*10^6 CD34+ cells/kg and the target is ≧4*10^6 CD34+ cells/kg. Success of transplant engraftment will be measured by the number of days to polymorphonuclear leukocytes (PMN) and platelet (PLT) engraftment. Durability of transplant will be assessed for a minimum of one year.

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 plerixafor alone can be used to mobilize peripheral blood progenitor cells (PBPCs) for transplantation in MM patients. The minimum number of CD34+ cells to collect is 2*10^6 CD34+ cells/kg and the target is ≧4*10^6 CD34+ cells/kg. Success of transplant engraftment will be measured by the number of days to polymorphonuclear leukocytes (PMN) and platelet (PLT) engraftment. Durability of engraftment will be assessed for a minimum of one year.

This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Participants with Multiple Myeloma (MM)

Participants with MM who were eligible for autologous peripheral blood stem cell transplantation.

Group Type: EXPERIMENTAL

plerixafor

Intervention Type: DRUG

Participants were given a 240 µg/kg dose of plerixafor by subcutaneous injection in the morning followed by apheresis 6 hours later. Daily treatment with plerixafor followed by apheresis was administered for up to 4 consecutive days or until 4\*10\^6 CD34+ cells/kg body weight had been collected.

Interventions

plerixafor

Participants were given a 240 µg/kg dose of plerixafor by subcutaneous injection in the morning followed by apheresis 6 hours later. Daily treatment with plerixafor followed by apheresis was administered for up to 4 consecutive days or until 4\*10\^6 CD34+ cells/kg body weight had been collected.

Intervention Type: DRUG

Other Intervention Names

Mozobil; AMD3100

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AnorMED

INDUSTRY

Sponsor Role: collaborator

Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Genzyme Corporation

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Genzyme, a Sanofi Company

Locations

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Countries

United States

References

Flomenberg N, Comenzo R, Badel K, Calandra G. Single agent AMD3100 mobilization of peripheral blood progenitor cells for autologous transplantation in patients with multiple myeloma (MM) [abstract]. Blood. Nov 16 2006;108(11 Pt 1):965a.

Reference Type: RESULT

Flomenberg N, Comenzo RL, Badel K, Calandra G. Plerixafor (Mozobil) alone to mobilize hematopoietic stem cells from multiple myeloma patients for autologous transplantation. Biol Blood Marrow Transplant. 2010 May;16(5):695-700. doi: 10.1016/j.bbmt.2009.12.538. Epub 2010 Jan 11.

Reference Type: RESULT

PMID: 20067838 (View on PubMed)

Other Identifiers

AMD3100-2108

Identifier Type: -

Identifier Source: org_study_id