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).

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Some patients with multiple myeloma or lymphoma will need treatment with high dose chemotherapy to treat their condition. This potent treatment will kill many of the blood-forming cells in the bone marrow. The patient will therefore need these blood-forming cells replaced after the chemotherapy treatment. This is done by collecting some of teh patients own blood-forming stem cells before chemotherapy, storing them and then infusing them into the patient after chemotherapy (in the same way as a blood transfusion is given). The stem cells will then make their way unto the bone marrow and re-populate it. Having stem cells collected and returned later is called an "Autologous Transplant".

In most patients these blood-forming stem cells (which normally live in the bone marrow) are "mobilized" into the blood stream where they are then collected by a process called apheresis (a bit like donating blood). This process of mobilization is not always successful. In this study patients who did not collect enough stem cells in a previous cell collection attempt to have an autologous stem cell transplant will participate. Patients will be mobilized with G-CSF (current standard treatment to mobilize stem cells) and the effect of adding AMD3100 to G-CSF will be studied by comparing outcomes in patients who get G-CDF with placebo (non-active substance which looks like AMD3100) to patients who get G-CSF with AMD3100.

AMD3100 is a member of a new class of medications called "chemokine inhibitors". The drug triggers the movement of stem cells out of the bone marrow into the blood stream. In previous studies with healthy volunteers and cancer patients, when AMD3100 and G-CSF were used in combination, a greater number of stem cells were mobilized into the blood stream than by using g-CSF alone.

The purposes of this study are to measure how many stem cells can be collected, the number of days to collect those cells and the safety of a mobilization regimen of AMD3100 with G-CSF compared to G-CSF with placebo. If enough cells are collected to have a transplant, the study will also evaluate how well the cells grow when transplanted.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genzyme, a Sanofi Company
• Treatments: JM 3100; Lenograstim; Plerixafor

Criteria

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.