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

NCT01171092 | Completed Early Phase 1 DMC

• 2 other identifiers: 11803X05279
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Malignant Lymphoma, Stem Cell Type; Autologous Transplant

Keywords

stem cell; transplant; myeloma; lymphoma; BMT; autologous

Outcome Measures

Primary Outcomes (1)

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

  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.

  100 days after transplant

Secondary Outcomes (1)

• Assess the safety of the combination of bortezomib and G-CSF

  365 days after transplant

Study Arms (1)

bortezomib and G-CSF

EXPERIMENTAL

Drug: bortezomib and G-CSF

Interventions

bortezomib and G-CSF DRUG

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

Also known as: Velcade, Filgrastim

bortezomib and G-CSF

Eligibility Criteria

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

You may qualify if:

• 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• Millennium Pharmaceuticals, Inc.: collaborator

Study Sites (2)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

University of Kansas Medical Center, Westwood Campus

Westwood, Kansas, 66205, United States

Location

MeSH Terms

Conditions

Lymphoma; Neoplasms, Plasma Cell

Interventions

Bortezomib; Granulocyte Colony-Stimulating Factor; Filgrastim

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; 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

Study Officials

• Sunil Abhyankar, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2010
• First Posted: July 28, 2010
• Study Start: September 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: December 1, 2014
• Last Updated: January 11, 2017

Record last verified: 2017-01

Locations

US (2)