Evaluation of the Drug Plerixafor in Combination With Chemotherapy and G-CSF for Stem Cell Collection

Completed · Phase 2

Conditions studied: Myeloma, Lymphoma

In brief

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.

Key facts

Study ID

NCT01095757

Run by

Emory University

People needed

45

Starts

2010-03-01

Expected to finish

2014-02-01

Last updated by the study team

2014-09-29

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Emory University Winship Cancer Institute — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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