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Phase I Study of Bortezomib With G-CSF for Stem Cell Mobilization in Patients With Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02220608
Recruitment Status : Completed
First Posted : August 20, 2014
Last Update Posted : January 8, 2018
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
The purpose of this research study is to determine the highest dose of a drug called bortezomib that can be given with a drug called G-CSF before stem cell collection to help in the mobilization of stem cells.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Biological: Bortezomib Drug: G-CSF Phase 1

Detailed Description:
The purpose of this phase I study is to define the maximum tolerated dose of bortezomib and its mobilization effects when given with G-CSF for stem cell mobilization in multiple myeloma patients. We hypothesize that bortezomib, in addition to increasing the number of mobilized stem cells, will optimize final apheresis product by decreasing myeloma cell contamination. Therefore, all multiple myeloma patients rather than multiple myeloma patients with G-CSF mobilization failure will be the target of this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of the Safety and Feasibility of Bortezomib in Combination With G-CSF for Stem Cell Mobilization in Patients With Multiple Myeloma
Actual Study Start Date : February 20, 2015
Actual Primary Completion Date : July 31, 2016
Actual Study Completion Date : November 30, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Bortezomib

Arm Intervention/treatment
Experimental: Arm 1: Dose Level 1 (Bortezomib & G-CSF)
G-CSF will be administered daily for 5 days (Days 1-5). On Day 4 at approximately 1800 hours, bortezomib will be administered. Apheresis will begin on Day 5 either 15 or 18 hours following Day 4 bortezomib dose; 20L of peripheral blood will be processed with a cumulative target collection goal of > 6.0x106 CD34+cells/kg. If the target collection goal is not met after one apheresis procedures, up to three additional days of G-CSF and apheresis may be repeated.
Biological: Bortezomib
Other Names:
  • Velcade
  • LDP 341
  • MLN341
  • PS-341

Drug: G-CSF
Other Names:
  • Neupogen
  • filgrastim XM02
  • granulocyte colony-stimulating factor
  • Recombinant Methionyl Human Granulocyte Colony Stimulating Factor
  • tbo-filgrastim
  • tevagrastim

Experimental: Arm 2: Dose Level 2 (Bortezomib & G-CSF)
G-CSF will be administered daily for 5 days (Days 1-5). On Day 4 at approximately 1800 hours, bortezomib will be administered. Apheresis will begin on Day 5 either 15 or 18 hours following Day 4 bortezomib dose; 20L of peripheral blood will be processed with a cumulative target collection goal of > 6.0x106 CD34+cells/kg. If the target collection goal is not met after one apheresis procedures, up to three additional days of G-CSF and apheresis may be repeated.
Biological: Bortezomib
Other Names:
  • Velcade
  • LDP 341
  • MLN341
  • PS-341

Drug: G-CSF
Other Names:
  • Neupogen
  • filgrastim XM02
  • granulocyte colony-stimulating factor
  • Recombinant Methionyl Human Granulocyte Colony Stimulating Factor
  • tbo-filgrastim
  • tevagrastim




Primary Outcome Measures :
  1. Maximum tolerated dose (MTD) of bortezomib when given with G-CSF [ Time Frame: Approximately 12 months (completion of all patients on trial) ]
    The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity during the first 28 days after administration of the first dose of bortezomib and before auto-HSCT. Dose escalations will proceed until the MTD has been reached.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed diagnosis of multiple myeloma.
  • Eligible for autologous transplantation.
  • Received at least two cycles of any regimen as initial systemic therapy for multiple myeloma and are within 2-12 months of the first dose of initial therapy.
  • At least 18 years of age.
  • ECOG performance status ≤ 2
  • Normal bone marrow and organ function as defined below:

    • Platelets ≥ 50,000/mm3
    • Hemoglobin ≥ 8.0 g/dL
    • Absolute neutrophil count ≥1,000/mm3
    • AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
    • Total bilirubin ≤ 1.5 x IULN
    • Measured or calculated creatinine clearance ≥ 30 mL/min
  • Female patients who:

    • are postmenopausal for at least 1 year before the screening visit OR
    • are surgically sterile OR
    • Women of childbearing potential and men must agree to practice 2 effective methods of contraception prior to study entry, for the duration of study participation, and for 30 days after the last dose of study treatment. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
  • Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Exclusion Criteria:

  • Previous stem cell collection or transplantation (autologous or allogeneic).
  • Evidence of multiple myeloma disease progression (as defined by IMWG) any time prior to auto-HSCT.
  • Diagnosis of plasma cell leukemia.
  • Concurrent hematologic or non-hematologic malignancy requiring treatment (other than multiple myeloma or secondary amyloidosis).
  • Radiation therapy within 3 weeks prior to enrollment.
  • Grade 2 or higher peripheral neuropathy.
  • Known hypersensitivity to any of the following: bortezomib, boron, mannitol.
  • Myocardial infarction within 6 months prior to enrollment or 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
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, or serious medical or psychiatric illness/social situations that would limit compliance with study requirements.
  • Female patients who are pregnant and/or breastfeeding. Patient must have a negative serum pregnancy test within 14 days of study entry.
  • Known HIV-positivity. These patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients with HIV-positivity when indicated.
  • Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of the trial and throughout the duration of the trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02220608


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Millennium Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Armin Ghobadi, M.D. Washington University School of Medicine
Additional Information:
Publications:
Ghobadi A, Holt M, Ritchey J et al. The effect of Bortezomib (B) Alone or in Combination with Other Agents for Stem Cell Mobilization in Mice. Blood (ASH Annual Meeting Abstracts), Nov 2012; 120: 583

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02220608    
Other Study ID Numbers: 201412026
1KL2TR002346-01 ( U.S. NIH Grant/Contract )
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: January 8, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Washington University School of Medicine:
Multiple Myeloma
G-CSF
Bortezomib
Additional relevant MeSH terms:
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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
Bortezomib
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents