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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00396383
• Date of registration: 02/11/2006
• Primary sponsor: Genzyme
• Public title: Treatment With AMD3100 (Plerixafor) in MM Patients to Mobilize PBCs For Collection and for Transplantation
• Scientific title: Treatment With AMD3100 in Multiple Myeloma Patients to Mobilize Peripheral Blood Progenitor Cells For Collection and for Transplantation
• Date of first enrolment: November 2004
• Target sample size: 9
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00396383
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Medical Monitor
• Affiliation: Genzyme

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Multiple Myeloma

Intervention(s)

Drug: plerixafor

Primary Outcome(s)

Number of Participants Who Achieved =4*10^6 CD34+ Cells/kg [Time Frame: Day 1 up to day 4]

Participant Counts of Summarized Adverse Events (AE) During Treatment [Time Frame: 1 month]

Secondary Outcome(s)

Number of Participants With a Durable Graft at 12 Months Post Transplantation [Time Frame: Approximately month 13]

Number of Transplantations That Achieved Platelet (PLT) Engraftment Grouped by Days to Engraftment [Time Frame: Approximately 2 months]

Number of Transplantations That Achieved Polymorphonuclear Leukocyte (PMN) Engraftment Grouped by Days to Engraftment [Time Frame: Approximately 2 months]

Secondary ID(s)

AMD3100-2108

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

AnorMED