Evaluation of the Safety and Efficacy of the Addition of AMD3100 to a G-CSF Mobilization Regimen in Patients With Lymphoma (NHL and HD) and Multiple Myeloma (MM).

This is an interventional treatment trial for Lymphoma focused on measuring Mobilisation stem cells, G-CSF Mobilisation Regimen, Lymphoma, Multiple Myeloma, Adult patients with lymphoma (Non Hodgkin's Lymphoma, Hodgkin's Disease) or Multiple Myeloma who previously failed Stem Cell Collections or Collection attempts. Read More

Inclusion Criteria:

• Eligible to undergo autologous transplantation.
• Diagnosis of NHL, HD or MM [patients with plasma cell leukemia or other leukemias including chronic lymphocytic leukemia (CLL), are excluded].
• In the last collection attempt prior to entry into this trial, the patient has failed to collect 0.8x10^6 cells/kg in at least 2 apheresis sessions or 2x10^6 cells/kg in 4 apheresis sessions using a mobilization regimen of chemotherapy, with or without G-CSF.
• A minimum of a 7 day interval between last collection attempt and randomization.
• Cardiac, pulmonary and renal function deemed clinically adequate to be able to undergo mobilization and transplant.
• Performance status, Eastern Cooperative Oncology Group (ECOG) of 0 or 1
• ≥ 21 days between the last cycle of chemotherapy and randomization (thalidomide, dexamethasone, and other corticosteroids, Rituxan® and Velcade® are not considered prior chemotherapy for the purpose of this study).
• The patient has recovered from all acute toxic effects of prior chemotherapy.
• WBC ≥ 2.5x10^9/l.
• Absolute neutrophil count ≥ 1.5x10^9/l.
• Platelet count ≥ 75x10^9/l.
• Adequate renal function as demonstrated by serum creatine ≤ or equal to 2.2 mg/dl or creatinine clearance (24 hr urine collection)≥ 60 ml/min
• Serum Glutamate Oxaloacetate Transaminase (SGOT), Serum Glutamate Pyruvate Transaminase (SGPT) and total bilirubin ≤ 2.5 x upper limit of normal (ULN).
• Signed informed consent.
• All patients must agree to use a highly effective method of contraception (including both female patients of child-bearing potential and male patients with child-bearing potential partners). Effective birth control includes: a) birth control pills, depo-progesterone, or an IUD PLUS one barrier method, or b) two barrier methods. Effective barrier methods are: male and female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm). For patients using hormonal contraceptive method, information about any interaction of MAD3100 with hormonal contraceptives is not known.

Exclusion Criteria:

• A co-morbid condition which, in the view of the Investigators, renders the patient at high risk from treatment complications.
• A residual acute medical condition resulting from prior chemotherapy.
• Received thalidomide, dexamethasone or corticosteroids, Rituxan® and Velcade® within 7 days prior to randomization.
• Brain metastases or carcinomatous meningitis.
• Active acute or chronic infection or anti-infective therapy within 1 week prior to randomization.
• Fever (temperature ≥ 38 degrees celsius).
• Hypercalcemia (≥ 1mg/dl above the ULN).
• Known to be HIV-positive.
• Pregnant and nursing females.
• Patient unwilling to implement adequate birth control (including both female patients of child-bearing potential and male patients with child-bearing potential partners).
• Patients who previously received experimental therapy within 4 weeks of randomization or who are currently enrolled in another experimental protocol during the Mobilization phase.
• Patients who have failed previous collection attempt within 7 days or less from randomization.