Clinical trial NCT01095757: Evaluation of the Drug Plerixafor in Combination With Chemotherapy and G-CSF for Stem Cell Collection
Official title: Evaluation of Plerixafor (Mozobil ™, AMD3100) in Combination With Chemotherapy and G-CSF for CD34+ Cell Mobilization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Myeloma
Lymphoma
Keywords: Myeloma
Lymphoma
Stem cell transplantation
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Genzyme, a Sanofi Company
First posted: 2010-03-30
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test whether the addition of the drug plerixafor to treatment with chemotherapy and G-CSF can better activate your bone marrow stem cells to improve the chances of transplant. The study will look for the activation of a certain type of blood cell, called CD34+ cells in patients who receive plerixafor, chemotherapy and G-CSF. The investigators will follow the number of patients that achieve the target numbers of CD34+ cells. The number of patients achieving the target level of CD34+ cells, and the total number of CD34+ cells, will be compared to the numbers in previous studies testing just chemotherapy and G-CSF, without plerixafor.

The investigators will also test the safety of the combination of plerixafor with chemotherapy and G-CSF and look at the success of the transplantation after 12 months.


Eligibility criteria: Inclusion Criteria:

1. Age 18-70 years
2. Multiple myeloma (MM) or non-Hodgkin's lymphoma (NHL) patients in first or second complete or partial remission
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
4. Up to 3 prior treatment regimens
5. Meet all eligibility requirements for autologous transplant
6. Adequate marrow function defined as white blood cells (WBC) \>3,000; ANC \>1,500/mm3; platelets \>75,000/mm3
7. Adequate renal function defined as creatinine clearance \> 30 mL/min by Cockcroft-Gault
8. Adequate liver function defined as aspartate aminotransferase (AST)/alanine aminotransferase (ALT)/bilirubin \< 2 times upper limit of normal
9. Able to provide informed consent
10. Women not pregnant and agree to use contraception

Exclusion Criteria:

1. High risk co-morbidities for acute treatment complications (e.g., symptomatic coronary artery disease)
2. Brain metastases or carcinomatous meningitis
3. Previous treatment with high dose chemotherapy and autologous transplant
4. Previous attempt to collect B-hematopoietic progenitor cells (HPCs) following mobilization with growth factors alone, growth factors and chemotherapy, or plerixafor and growth factors
5. Acute infection or unexplained fever \>38°C
6. Weight \> 175% of ideal body weight as defined by the Devine equation
7. Experimental therapy within 4 weeks
8. Cytokine administration in the previous 14 days

Primary outcomes:
measure: Patients Achieving Greater Than or Equal to 5 x 10^6 of CD34+ Cells/kg in a Single Day of Apheresis
timeFrame: Within the first 4 days following the first dose of Plerixafor
measure: Patients Achieving >= 3 X 10^6 CD34+ Cell/Kg
timeFrame: Within the first 4 days following the first dose of Plerixafor
Secondary outcomes:
measure: Average Number of Days for Engraftment (Engraftment Defined as Absolute Neutrophil Count>500)
timeFrame: Within the first 4 days following the first dose of Plerixafor
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Winship Cancer Institute
state: Georgia
Study officials:
affiliation: Emory University Winship Cancer Institute
name: Edmund Waller, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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