Mobilization of stem cells prior to autologous stem cell transplantation in patients with multiple myeloma, non-Hodgkin's lympoma, and Hodgkin's disease. MedDRA version: 8.1 Level: LLT Classification code 10029547 Term: Non-Hodgkin's lymphoma MedDRA version: 9.1 Level: LLT Classification code 10028228 Term: Multiple myeloma MedDRA version: 9.1 Level: LLT Classification code 10020206 Term: Hodgkin's disease
Conditions
Sponsors
Genzyme Europe BV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18 to 78 years. 2. Eligible to undergo autologous transplantation. 3. Diagnosis of NHL, HD or MM [patients with plasma cell leukemia or other leukemias, including chronic lymphocytic leukemia (CLL), are excluded]. 4. In the last collection attempt prior to entry into this trial, the patient has failed to collect 0.8X10E6 cells/kg in at least 2 apheresis sessions or 2X10E6 cells/kg in 4 apheresis sessions using a mobilization regimen of chemotherapy, with or without G-CSF. NOTE: The complete history of the failed collection and/or collection attempts, including the mobilization regimen, apheresis yield(s), and/or peripheral blood (PB) CD34+ cell count(s) will be documented and submitted to Genzyme prior to enrollment and randomization. 5. A minimum of a 7-day interval between last collection attempt and randomization. 6. Performance status, Eastern Cooperative Oncology Group (ECOG) of 0 or 1 (see Appendix E). 7. Cardiac, pulmonary and renal function deemed clinically adequate to be able to undergo mobilization and transplant. 8. =/> 21 days between the last cycle of chemotherapy (e.g. cyclophosphamide) and randomization (thalidomide, dexamethasone, and other corticosteroids, Rituxan and Velcade are not considered prior chemotherapy for the purpose of this study). 9. The patient has recovered from all acute toxic effects of prior chemotherapy. 10. WBC > 2.5X10E9/l. 11. Absolute neutrophil count >1.5X10E9/l. 12. Platelet count > 75X10E9/l. 13. Adequate renal function as demonstrated by serum creatinine 60 ml/min. 14. Serum Glutamate Oxaloacetate Transaminase (SGOT), Serum Glutamate Pyruvate Transaminase (SGPT) and total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. A co-morbid condition which, in the view of the Investigators, renders the patient at high risk from treatment complications. 2. A residual acute medical condition resulting from prior chemotherapy. 3. Received thalidomide, dexamethasone or corticosteroids, Rituxan and Velcade within 7 days prior to randomization. 4. Brain metastases or carcinomatous meningitis. 5. Active acute or chronic infection or anti-infective therapy within 7 days of randomization. 6. Fever (temperature > 38°C). 7. Hypercalcaemia (> 1 mg/dl above the ULN). 8. Known to be HIV-positive. 9. Pregnant and nursing females. 10. Patient unwilling to implement adequate birth control (including both femalepatients of child-bearing potential and male patients with child-bearing potential partners). 11. Patients who previously received experimental therapy within 4 weeks of randomization or who are currently enrolled in another experimental protocol during the Mobilization phase. 12. Patients who have failed a previous collection attempt within 7 days or less from randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if patients reach a target of >= 2x10E6 cells/kg within 2 days of apheresis in NHL, HD or MM patients who are documented poor mobilizers that have received a mobilization regimen of G-CSF with placebo or a mobilization regimen of G-CSF with AMD3100. ;Secondary Objective: 1. To examine and compare the safety of both mobilization regimens, G-CSF plus AMD3100 (240 µg/kg) and G-CSF plus placebo in NHL, MM and HD patients. 2. To measure the daily and total number of CD34+ cells harvested during apheresis. 3. To measure the number of days of apheresis needed to harvest > 2x10E6 CD34+ cells/kg. 4. To measure the number of days of apheresis needed to harvest > 5x10E6 CD34+ cells/kg. 5. To determine the times of PLT and PMN engraftment 6. To evaluate the durability of PLT and PLM engraftment 7. To determine if patients reach the Optimum Target of >= 5x10E6 CD34+ cells/kg within 4 days of apheresis ;Primary end point(s): The efficacy of AMD3100 is demonstrated by the ability to mobilize and collect stem cells. The primary efficacy endpoint is the binary response variable categorizing whether the patient was able to mobilize a minimum of at least 2x10E6 CD34+ cells/kg within 2 days of apheresis. | — |
Countries
Germany
Outcome results
None listed