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.

• Conditions: 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: 8.1Level: LLTClassification code 10029547Term: Non-Hodgkin's lymphoma; MedDRA version: 9.1Level: LLTClassification code 10028228Term: Multiple myeloma; MedDRA version: 9.1Level: LLTClassification code 10020206Term: Hodgkin's disease

• Registration Number: EUCTR2006-004247-29-DE
• Lead Sponsor: Genzyme Europe BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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 < 2.5 X upper limit of normal (ULN).
15. No active Hepatitis A, B or C infection.
16. Signed informed consent.
17. 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, depot 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 a hormonal contraceptive method, information about any interaction of AMD3100 with hormonal contraceptives is not known.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified