Status:
COMPLETED
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).
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Lymphoma
Non Hodgkin's Lymphoma
Eligibility:
All Genders
18-78 years
Phase:
PHASE2
Brief 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 ma...
Detailed Description
This is a multicenter, randomized, comparative, patient-blinded study. Patients with NHL, HD or MM who would benefit from an autologous stem cell transplant, who failed previous collections or collect...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00665314
Start Date
November 1 2007
End Date
June 1 2009
Last Update
February 11 2014
Active Locations (5)
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1
Berlin, Germany
2
Cologne, Germany
3
Dresden, Germany
4
Nuremberg, Germany