A Multicenter, Randomized, Comparative, Patient-blinded Study to Evaluate the Safety and Efficacy of G-CSF Alone Versus AMD3100 (240 µg/kg) Added to a G-CSF Mobilization Regimen in Adult Patients with Non-Hodgkin’s Lymphoma (NHL), Hodgkin’s Disease (HD) or Multiple Myeloma (MM) Who Have Previously Failed Stem Cell Collections.

Genzyme Europe BV0 sitesMarch 11, 2009

Overview

No summary available.

Registry

who.int

Start Date

March 11, 2009

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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.

•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).