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

Refractory Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01301963
• Other study ID #: CASE3A10
• Secondary ID: NCI-2011-00186
• Status: Terminated
• Phase: Phase 3
• First received: February 22, 2011
• Last updated: July 7, 2014
• Start date: July 2011

Study information

• Verified date: July 2014
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Refractory Multiple Myeloma

Intervention

Drug:
• plerixafor
Given SC

Biological:
• filgrastim
Given SC

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability to Reach Target Collection of 5 x 10^6 CD34+ Cells/kg		In =< 2 days of leukaphereses	No
Secondary	Percentage of Patients Achieving Target Goal CD34+ Cells Dose		In =< 5 days of leukaphereses	No
Secondary	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	No
Secondary	Compare Days of Apheresis Between Mobilization Groups	Using the Wilcoxon Rand Sum Test	Day 1	No
Secondary	Compare Need for Hospitalization During Mobilization Between Mobilization Groups		Day 1	No
Secondary	Compare Need for Remobilization Between Mobilization Groups	Using the Chi-square test or Fisher's exact test, as appropriate.	Day 1	No