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

NCT ID: NCT01301963

Last Updated: 2014-08-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31

Brief 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

Detailed Description

PRIMARY OBJECTIVES:

I. Ability to reach target collection of 5 x 10^6 CD34+ cells/Kg with =< 2 days of leukaphereses using one of two mobilization regimens.

SECONDARY OBJECTIVES:

I. Percentage of patients achieving target goal CD34+ cell dose (as above) in =< 5 days of leukaphereses.

II. Compare collections between different mobilization regimens in those patients who are crossed over from one mobilization regimen to the other.

III. Compare days of apheresis, need for hospitalization during mobilization, and need for remobilization between mobilizing groups.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive G-CSF subcutaneously (SC) once daily (QD) on days 1-8.

ARM II: Patients receive G-CSF SC QD on days 1-7 and plerixafor SC QD on days 4-7.

After completion of study treatment, patients are followed up at 14 days.

Conditions

Refractory Multiple Myeloma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I

Patients receive G-CSF SC QD on days 1-4.

Group Type: ACTIVE_COMPARATOR

filgrastim

Intervention Type: BIOLOGICAL

Given SC

Arm II

Patients receive G-CSF SC QD on days 1-4 and plerixafor SC QD on days 4-8.

Group Type: EXPERIMENTAL

plerixafor

Intervention Type: DRUG

Given SC

filgrastim

Intervention Type: BIOLOGICAL

Given SC

Interventions

plerixafor

Given SC

Intervention Type: DRUG

filgrastim

Given SC

Intervention Type: BIOLOGICAL

Other Intervention Names

AMD 3100; Mozobil; G-CSF; Neupogen

Eligibility 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hien Duong, MD

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Hillard Lazarus, MD

Role: PRINCIPAL_INVESTIGATOR

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Locations

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

Countries

United States

Other Identifiers

NCI-2011-00186

Identifier Type: REGISTRY

Identifier Source: secondary_id

CASE3A10

Identifier Type: -

Identifier Source: org_study_id