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

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Case Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: JM 3100; Lenalidomide; Lenograstim; Plerixafor

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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