Plerixafor in Treating Patients With Multiple Myeloma Previously Treated With Lenalidomide and Planning to Undergo Autologous Stem Cell Transplant

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00998049
First received: October 19, 2009
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

Rationale: 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. Purpose: This phase II trial is studying how well plerixafor works in patients with multiple myeloma previously treated with lenalidomide and planning to undergo autologous stem cell transplant.


Condition Intervention Phase
Multiple Myeloma
Refractory Multiple Myeloma
Stage I Multiple Myeloma
Stage II Multiple Myeloma
Stage III Multiple Myeloma
Drug: plerixafor
Drug: filgrastim
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Intravenously Administered AMD3100 (Plerixafor) for Stem Cell Mobilization in Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplantation Following a Lenalidomide Based Initial Therapy

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Number of Patients Achieving 3 Million CD34 Cells/kg After 2 Days of Apheresis [ Time Frame: After 2 days of apheresis ] [ Designated as safety issue: No ]

    Number of CD34 cells/kg collected on days 1-2.

    Apheresis is the process when blood is taken out through a catheter in a vein in one arm, blood is sent through a machine that takes out the stem cells and the rest of the blood is then returned through a vein in your other arm.



Secondary Outcome Measures:
  • CD34 Yield on Day 1 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Number of CD34 cells/kg collected on day 1.

  • CD34 Yield Day 2 [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
    Number of CD34 cells/kg collected on day 2

  • Median Number of Days of Apheresis [ Time Frame: Duration of apheresis (up to 7 days) ] [ Designated as safety issue: No ]
  • Time to Reach 6 Million CD34 Cells [ Time Frame: Duration of apheresis (up to 7 days) ] [ Designated as safety issue: No ]
    Number (median and 95% confidence interval) of days to reach 6 million CD34 cells/kg was estimated using the Kaplan Meier method. Participants were lower than 6 million CD34 cells/kg at time of last follow-up will be censored at that date.

  • Rate of Failure to Mobilize [ Time Frame: Duration of apheresis (up to 7 days) ] [ Designated as safety issue: No ]
    The rate of failure to mobilize will be estimated by dividing the number of patients that fail to mobilize by the total number of evaluable patients. A patient is considered a failure if they never achieve 2.5 million CD34 cells/kg.


Enrollment: 40
Study Start Date: December 2009
Estimated Study Completion Date: December 2014
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Plerixafor

Plerixafor 160mg/kg/dose by IV on days 5-8

Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8.

Drug: plerixafor
Plerixafor 160mg/kg/dose by IV on days 5-8
Other Names:
  • AMD 3100
  • LM-3100
  • Mozobil
Drug: filgrastim
Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8.
Other Names:
  • G-CSF
  • granulocyte colony-stimulating factor
  • Neupogen
  • r-metHuG-CSF
  • Recombinant Methionyl Human Granulocyte Colony Stimulating Factor

Detailed Description:

Primary Objective: I. To determine the proportion of patients reaching a stem cell yield of 3 million CD34 cells/kg by second day of apheresis with intravenously administered AMD3100 among patients receiving primary therapy for myeloma with lenalidomide. Secondary Objectives: I. Safety and tolerability of intravenously administered AMD3100. II. Rate of failure to mobilize. Outline: Patients receive plerixafor IV on days 5-8 and filgrastim subcutaneously on days 1-8 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion - Absolute neutrophil count >= 1000/uL - Platelet >= 75000/uL - Hemoglobin >= 8.0 g/dL - Serum aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT), serum alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) and total bilirubin < 2 x upper limit of normal (ULN) - Confirmed diagnosis of multiple myeloma, requiring therapy - Initial treatment for symptomatic myeloma using a lenalidomide based treatment regimen, started =< 12 months prior to registration - Received at least 2 cycles of treatment with the lenalidomide regimen - Last dose of lenalidomide > 2 weeks prior to registration - Eligible to undergo autologous transplantation - ECOG performance status (PS) 0 or 1 - Willingness to return for follow-up - Provide informed written consent - Adequate cardiopulmonary function: ejection fraction >= 45%, corrected pulmonary diffusion capacity of >= 50%, FEV1 >= 50%, FVC >= 50% - Negative serum or urine pregnancy test done =< 7 days prior to registration, for women of childbearing potential only Exclusion - A co-morbid condition which, in the view of the Investigators, renders the patient at high risk from treatment complications - Active malignancy with the exception of non melanoma skin cancer or in situ cervical or breast cancer - Other co-morbidity which would interfere with patient's ability to participate in the trial, e.g. uncontrolled infection, uncompensated heart or lung disease - Other concurrent chemotherapy, radiotherapy, or any ancillary therapy considered investigational - Use of cyclophosphamide as part of stem cell mobilization - Use of more than one regimen for treatment of symptomatic myeloma - Dialysis dependent renal failure - Pregnant women or women of reproductive ability who are unwilling to use effective contraception - Nursing women - Men who are unwilling to use a condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking the drug and for 4 weeks after stopping treatment - Acute infection, active HIV infection

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00998049

Locations
United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: Shaji Kumar, M.D. Mayo Clinic
Principal Investigator: Joseph R. Mikhael, M.D. Mayo Clinic in Arizona
  More Information

No publications provided

Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00998049     History of Changes
Other Study ID Numbers: MC0889, NCI-2009-01328, MC0889, 08-005644
Study First Received: October 19, 2009
Results First Received: June 26, 2012
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Lenograstim
JM 3100
Lenalidomide
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 24, 2014