Filgrastim With or Without Plerixafor in Treating Patients With Multiple Myeloma Previously Treated With Lenalidomide

Stopped early · Phase 3

Conditions studied: Refractory Multiple Myeloma

In brief

This clinical trial studies filgrastim (G-CSF) with or without plerixafor in treating patients with multiple myeloma (MM) previously treated with lenalidomide. Giving colony-stimulating factors, such as G-CSF, and plerixafor helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored

Key facts

Study ID

NCT01301963

Run by

Case Comprehensive Cancer Center

People needed

9

Starts

2011-07-01

Last updated by the study team

2014-08-06

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of MM by International Myeloma Working Group Criteria
• In first or second complete or partial remission or stable refractory but not actively progressing myeloma according to the classifications provided by The Center for International Blood \& Marrow Transplant Research
• Received at least 2 cycles of lenalidomide therapy
• Patients with MM scheduled to undergo stem cell harvest for possible allogeneic stem cell transplant (ASCT)
• At least 2 weeks since last exposure to lenalidomide
• Eastern Cooperative Oncology Group performance status of 0 or 1
• Prior to the start of mobilization:
• white blood cell count >/= 2.5 x 10\^9/L
• absolute neutrophil count >/= 1.2 x 10\^9/L
• platelet count >/=100 x 10\^9/L
• creatinine clearance >/= 30mL/minute
• If childbearing potential, must either agree to complete abstinence from heterosexual intercourse or effective means of contraception during stem cell mobilization; female patients will undergo pregnancy test prior to stem cell mobilization therapy

You may not qualify if…

• Had prior autologous or allogeneic transplantation
• Received pegfilgrastim within 3 weeks or G-CSF within 14 days of first dose of G-CSF for mobilization
• Failed previous hematopoietic stem cell collections or collection attempts
• Received radiation therapy to the pelvic area
• Received lenalidomide within 2 weeks of first dose of G-CSF for mobilization
• Had received experimental therapy within 4 weeks of enrolling in study
• Current or prior history of other malignancies, excluding basal cell carcinoma of the skin

Where it is running

• Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center — Cleveland, Ohio, United States
• Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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