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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

Phase 0
18 Years
Open (Enrolling)
Malignant Lymphoma, Stem Cell Type, Autologous Transplant

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Trial Information

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

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

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.

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not part of normal medical care, with the understanding that consent may be withdrawn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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the effectiveness of the combination of bortezomib and G-CSF

Outcome Description:

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.

Outcome Time Frame:

100 days after transplant

Safety Issue:


Principal Investigator

Sunil Abhyankar, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Kansas


United States: Institutional Review Board

Study ID:




Start Date:

September 2010

Completion Date:

October 2013

Related Keywords:

  • Malignant Lymphoma, Stem Cell Type
  • Autologous Transplant
  • stem cell
  • transplant
  • myeloma
  • lymphoma
  • BMT
  • autologous
  • Lymphoma



University of Kansas Medical Center Kansas City, Kansas  66160-7353
University of Kansas Medical Center, Westwood Campus Kansas City, Kansas  66205