Multiple Myeloma Clinical Trial
Official title:
Treatment With AMD3100 in Non-Hodgkin's Lymphoma and Multiple Myeloma Patients to Increase the Number of Peripheral Blood Stem Cells When Given a Mobilizing Regimen of G-CSF
Verified date | February 2014 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This study evaluates the safety and efficacy of plerixafor given in addition to granulocyte-colony stimulating factor (G-CSF) for collection of peripheral blood stem cells (PBSCs) for autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) and multiple myeloma (MM). Efficacy outcomes include evaluation of fold increase in circulating CD34+ cells from just before the first plerixafor injection to 10-11 hours post plerixafor (just before apheresis) and assessment of successful polymorphonuclear leukocyte (PMN) engraftment after transplantation. Data from this protocol will assist in the determination of the dosing schedule for future studies.
Status | Completed |
Enrollment | 49 |
Est. completion date | June 2006 |
Est. primary completion date | June 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Diagnosis of non-Hodgkin's lymphoma (NHL) or multiple myoloma (MM) eligible for autologous transplantation - No more than 3 prior regimens of chemotherapy - More than 4 weeks since last cycle of chemotherapy. Patient recovered from all acute toxic effects of prior chemotherapy. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - White blood cell (WBC) count >3.0*10^9/L - Absolute polymorphonuclear cells (PMN) count >1.5*10^9/L - Platelet (PLT) count >100*10^9/L - Serum creatinine <=2.2 mg/dL - Serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT) and total bilirubin <2 x upper limit of normal (ULN) - Left ventricle ejection fraction >45% by normal echocardiogram or multiple-gated acquisition (MUGA) scan - Forced expiratory volume of the lung in the first second (FEV1) >60% of predicted or diffusing capacity of the lung for carbon monoxide (DLCO) >45% of predicted - Negative for human immunodeficiency virus (HIV) type 1 - Women of child bearing potential agreed to use an approved form of contraception. Exclusion Criteria: - Patients who have failed previous collections - Brain metastases or carcinomatous meningitis - History of ventricular arrhythmias - A co-morbid condition which, in the view of the investigator, renders the patient at high risk for treatment complications - A residual acute medical condition resulting from prior chemotherapy - Acute infection - Fever (temp >38°C/100.4°F) - Patients whose actual body weight exceeds 175% of their ideal body weight - Patients who previously received experimental therapy within 4 weeks of enrolling in this study or who are currently enrolled in another experimental study during the mobilization period - Positive pregnancy test in female patients - Lactating females - Patients of child-bearing potential unwilling to implement adequate birth control. - Patients who have deterioration of their clinical status or laboratory parameters between the time of enrolment and transplant (such that they no longer meet entry criteria) may be removed from study at the discretion of the treating physician, principal investigator, or sponsor. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | University of Iowa | Iowa City | Iowa |
United States | University of Arkansas for Medical Sciences | Little Rock | Arkansas |
United States | UCLA School of Medicine | Loa Angeles | California |
United States | Loyola University Medical Center | Maywood | Illinois |
United States | University of Minnesota | Minneapolis | Minnesota |
United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Genzyme, a Sanofi Company | AnorMED |
United States,
Stiff P, Micallef I, McCarthy P, Magalhaes-Silverman M, Weisdorf D, Territo M, Badel K, Calandra G. Treatment with plerixafor in non-Hodgkin's lymphoma and multiple myeloma patients to increase the number of peripheral blood stem cells when given a mobili — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Median Cumulative Number of CD34+ Cells Collected During Apheresis | Median cumulative total number of CD34+ cells collected during apheresis. | Days 5-8 | No |
Other | Number of Transplants in Which Participants Achieved Platelet (PLT) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant | Participants were monitored for platelet (PLT) engraftment as per the local standard of care. The target for engraftment was 12 days after PBSC transplant and no transplant taking longer than 21 days for engraftment. | 2 months | No |
Other | Number of Participants With Durable Engraftment 12 Months After Transplantation | The number of participants maintaining a durable graft 12 months after autologous transplantation. A durable graft is defined as the maintenance of normal blood counts. | Approximately 13 months (12 months post-transplant ) | No |
Primary | Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE) | Number of participants with treatment emergent adverse events (TEAEs) collected from Day 1 (start of G-CSF mobilization) to the day before starting chemotherapy (approximately day 38). AEs were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe) and relatedness to study treatment (5 point scale from 'not related' to 'definitely related'). | Day 1 to approximately Day 38 (before start of chemotherapy) | Yes |
Secondary | Number of Participants Achieving a Two-Fold (Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL Following the First Dose of Plerixafor | The number of participants mobilized with G-CSF + plerixafor injection who have a = 2-fold increase in CD34+ cells. Fold increase was expressed as a ratio. Fold increase = (pre-apheresis PB CD34+ cells/µL) / (pre-plerixafor dosing PB CD34+ cells/µL) | Days 4-5 (first dose of plerixafor to apheresis) | No |
Secondary | Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant | Participants were monitored for polymorphonuclear leukocyte (PMN) engraftment as per the local standard of care. The target for engraftment was 12 days after PBSC transplant and no transplant taking longer than 21 days for engraftment. | 2 months | No |
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