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

Comparison of Plerixafor and G-CSF Versus G-CSF Alone for Stem Cell Mobilization in Patients With Multiple Myeloma Previously Treated With Lenalidomide

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

Study Overview

• Status: Terminated
• Conditions: Refractory Multiple Myeloma
• Intervention / Treatment: Biological: filgrastim; Drug: plerixafor

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
    • Cleveland, Ohio, United States, 44106
      • Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm I; Patients receive G-CSF SC QD on days 1-4.	Biological: filgrastim; Given SC; Other Names: G-CSF; Neupogen
Experimental: Arm II; Patients receive G-CSF SC QD on days 1-4 and plerixafor SC QD on days 4-8.	Biological: filgrastim; Given SC; Other Names: G-CSF; Neupogen; Drug: plerixafor; Given SC; Other Names: Mozobil; AMD 3100

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Ability to Reach Target Collection of 5 x 10^6 CD34+ Cells/kg	In =< 2 days of leukaphereses

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients Achieving Target Goal CD34+ Cells Dose		In =< 5 days of leukaphereses
Compare Hematopoietic Stem Cells/kg Collections Between Different Mobilization Regimens in Those Patients Who Are Crossed Over From One Mobilization Regimen to the Other	Patients will be randomized to receive either G-CSF or Plerixafor with G-CSF. All patients will undergo at least 2 days of leukopheresis. Cells/kg between these 2 arms will be compared. For those patients that do not reach the target goal will undergo a wash-out period and cross over to the other study arm.	By day 1
Compare Days of Apheresis Between Mobilization Groups	Using the Wilcoxon Rand Sum Test	Day 1
Compare Need for Hospitalization During Mobilization Between Mobilization Groups		Day 1
Compare Need for Remobilization Between Mobilization Groups	Using the Chi-square test or Fisher's exact test, as appropriate.	Day 1

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Hien Duong, MD, Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center; Principal Investigator: Hillard Lazarus, MD, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: February 22, 2011
• First Submitted That Met QC Criteria: February 22, 2011
• First Posted (Estimate): February 23, 2011

Study Record Updates

• Last Update Posted (Estimate): August 6, 2014
• Last Update Submitted That Met QC Criteria: July 7, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell; Anti-Infective Agents; Antiviral Agents; Anti-HIV Agents; Anti-Retroviral Agents; Plerixafor
• Other Study ID Numbers: CASE3A10; NCI-2011-00186 (Registry Identifier: CTRP (Clinical Trial Reporting Program))