A Safety Study Looking at the Combination of Velcade and G-CSF in Patients With Myeloma or Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
University of Kansas
ClinicalTrials.gov Identifier:
NCT01171092
First received: July 26, 2010
Last updated: December 30, 2013
Last verified: December 2013
  Purpose

The purpose of this study is to determine if the combination of G-CSF and bortezomib is safe and effective in blood cell mobilization.


Condition Intervention Phase
Malignant Lymphoma, Stem Cell Type
Autologous Transplant
Drug: bortezomib and G-CSF
Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Trial to Assess Mobilization of Hematopoietic Progenitor Cells With a Combination of Bortezomib and G-CSF in Patients Undergoing Autologous Transplant for Myeloma and Lymphoma

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Determine the effectiveness of the combination of bortezomib and G-CSF [ Time Frame: 100 days after transplant ] [ Designated as safety issue: Yes ]
    The primary aim of this single-arm pilot study is to determine the effectiveness of a combination of Bortezomib and G-SCSF in blood stem cell mobilization through the estimation of the proportion of patients receiving treatment that obtain adequate stem cell yield.


Secondary Outcome Measures:
  • Assess the safety of the combination of bortezomib and G-CSF [ Time Frame: 365 days after transplant ] [ Designated as safety issue: Yes ]
    Assess the safety of the study mobilization regimen


Estimated Enrollment: 20
Study Start Date: September 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: bortezomib and G-CSF Drug: bortezomib and G-CSF

Bortezomib injection:

1.3mg/m2 11 days before and 8 days before the stem cell collection

G-CSF injection:

10mcg/kg on days -4 to day -1 once daily

Other Names:
  • Velcade
  • Filgrastim

Detailed Description:

The study plans to use VELCADE for two doses followed by G-CSF given for 4 doses as is standard for mobilization with G-CSF alone. The rationale for VELCADE prior to the G-CSF is because VELCADE causes thrombocytopenia, similar to how cyclophosphamide is given followed by G-CSF for stem cell mobilization. Usually a cycle of VELCADE for myeloma therapy consists of 4 doses, but this may result in more significant drop in the platelet count. Low platelet counts may preclude adequate stem cell collection. The mobilization with VELCADE and GCSF will be approximately 3 -4 weeks after completion of the initial therapy for the primary disease.

Patients meeting eligibility criteria and who give informed consent will be mobilized using bortezomib at 1.3mg/m2 on day -11 and day -8. Subsequently G-CSF will be administered subcutaneously from day -4 to day -1 as a once daily injection at the standard /established dose of 10mcg/kg. Stem cell collection will be done on day 0 per standard of care regimen and protocol with processing of 4 -5 blood volumes. Stem cell enumeration by flow cytometry will be done prior to the collection by flow cytometry. The number of CD 34 positive cells (stem cell phenotype) / kg obtained each day of collection will be noted. G-CSF will be continued daily until adequate numbers of stem cells are obtained for the performance of a single autologous transplant (> 2.5 million CD 34 cells/kg of weight. Subsequently the data for engraftment of neutrophils and platelets will be monitored as is routine for all patients undergoing autologous transplant.

  Eligibility

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

Inclusion Criteria:

  • Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
  • Female subject is either post-menopausal for at least 1 year before the screening visit, or surgically sterilized or if they are of childbearing potential, agree to practice 2 effective methods of contraception from the time of signing the informed consent form through 30 days after the last dose of VELCADE, or agree to completely abstain from heterosexual intercourse.
  • Male subject, even if surgically sterilized (ie, status post vasectomy) must agree to 1 of the following: practice effective barrier contraception during the entire study treatment period and through a minimum of 30 days after the last dose of study drug, or completely abstain from heterosexual intercourse.
  • > 18 yrs of age needing to undergo an autologous blood stem cell transplant for the treatment of multiple myeloma or lymphoma

Exclusion Criteria Patients meeting any of the following exclusion criteria are not to be enrolled in the study.

  • Patient has a platelet count of < 100x 109/L within 14 days before enrollment.
  • Patient has an absolute neutrophil count of < 1.0x109/ within 14 days before enrollment.
  • Patient has > 1.5 x ULN Total Bilirubin
  • Patient has a calculated or measured creatinine clearance of < 50 mL/minute within 14 days before enrollment.
  • Patient has ≥ Grade 2 peripheral neuropathy.
  • Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
  • Patient has hypersensitivity to VELCADE, boron or mannitol or G-CSF
  • Female subject is pregnant or lactating. Confirmation that the subject is not pregnant must be established by a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
  • Female patients who are lactating or have a positive serum pregnancy test during the screening period, or a positive urine pregnancy test on Day 1 before first dose of study drug, if applicable.
  • Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial until 2 weeks after patient has received the last dose of Velcade for mobilization.
  • Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
  • Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.
  • Treated with VELCADE in the past 30 days
  • Radiation therapy within 3 weeks before randomization. Enrollment of subjects who require concurrent radiotherapy (which must be localized in its field size) should be deferred until the radiotherapy is completed and 3 weeks have elapsed since the last date of therapy.
  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: NCT01171092

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
University of Kansas Medical Center, Westwood Campus
Westwood, Kansas, United States, 66205
Sponsors and Collaborators
University of Kansas
Millennium Pharmaceuticals, Inc.
Investigators
Principal Investigator: Sunil Abhyankar, MD University of Kansas
  More Information

No publications provided

Responsible Party: University of Kansas
ClinicalTrials.gov Identifier: NCT01171092     History of Changes
Other Study ID Numbers: 11803, X05279
Study First Received: July 26, 2010
Last Updated: December 30, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by University of Kansas:
stem cell
transplant
myeloma
lymphoma
BMT
autologous

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bortezomib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 23, 2014