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

NCT01301963 | Terminated Phase 3 Results DMC

• 2 other identifiers: CASE3A10NCI-2011-00186
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

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

Conditions

Refractory Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Ability to Reach Target Collection of 5 x 10^6 CD34+ Cells/kg

  In =< 2 days of leukaphereses

Secondary Outcomes (5)

• 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

  By day 1

• Compare Days of Apheresis Between Mobilization Groups

  Day 1

• Compare Need for Hospitalization During Mobilization Between Mobilization Groups

  Day 1

• Compare Need for Remobilization Between Mobilization Groups

  Day 1

Study Arms (2)

Arm I

ACTIVE COMPARATOR

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

Biological: filgrastim

Arm II

EXPERIMENTAL

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

Drug: plerixafor; Biological: filgrastim

Interventions

plerixafor DRUG

Given SC

Also known as: AMD 3100, Mozobil

Arm II

filgrastim BIOLOGICAL

Given SC

Also known as: G-CSF, Neupogen

Arm I; Arm II

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

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

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

plerixafor; Filgrastim; Granulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Hien Duong, MD
• Organization: CCCC

duongh@ccf.org

216-445-5531

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2011
• First Posted: February 23, 2011
• Study Start: July 1, 2011
• Primary Completion: June 1, 2013
• Last Updated: August 6, 2014
• Results First Posted: August 6, 2014

Record last verified: 2014-07

Locations

US (2)