Exploratory Trial to Estimate Proportion of Patients With Tumor Cell Contaminated Leukapheresis Products With and Without Bortezomib With In-vivo Purging - Multiple Myeloma (MM)

May 24, 2021 updated by: Siddhartha Ganguly

An Exploratory Trial to Estimate the Proportion of Patients With Tumor Cell Contaminated, Flow Positive Leukapheresis Products Collected With and Without Bortezomib as In-vivo Purging Prior to Autologous Stem Cell Harvest for Multiple Myeloma

Explore stem cell collection with or without bortezomib with in-vivo purging in multiple myeloma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

High dose chemotherapy with autologous stem cell transplant has resulted in improved overall survival and is currently considered an effective first line therapy applicable to the majority of patients with multiple myeloma. However disease relapse is inevitable and remains the primary cause of mortality in this cohort.

The purpose of this study is to estimate the proportion of subjects with plasma cell contamination of harvested stem cell product in standard and treatment arms. The study will explore whether or not in-vivo purging of malignant tumor plasma cells will improve progression free survival (PFS) for patients.

The study will consist of two groups:

Group A: Standard of Care (SOC) stem cell collection without in-vivo purging with bortezomib. Granulocyte colony-stimulating factor (G-CSF) and Mozobil used if needed.

Group B: Bortezomib 1.3mg/m^2 will be given subcutaneously (SQ) on days -11 and -8 followed by Granulocyte colony-stimulating factor (G-CSF) on days -4 through -1 prior to stem cell harvest (day 0).

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Westwood, Kansas, United States, 66205
        • The University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects must meet all of the inclusion criteria to participate in this study.
  • Ability to understand, and the willingness to sign a written Informed Consent Form
  • Diagnosis of multiple myeloma undergoing planned autologous stem cell transplantation
  • Age ≥ 18 years
  • Karnofsky Performance Status (KPS) 70 or above, Eastern Cooperative Oncology Group (ECOG) 0, 1 or 2

  • Adequate organ and marrow function as defined below:

    • leukocytes ≥ 3,000/micro Liter (mcL)
    • absolute neutrophil count ≥ 1,500/mcL
    • platelets ≥ 100,000/mcL
    • total bilirubin within normal institutional limits NOTE: For this study, subjects with bilirubin levels > 1.5 Upper Limit of Normal (ULN) are excluded from enrollment in this study.
    • Aspartate Aminotransferase (AST) ( Serum Glutamic Oxaloacetic Transaminase [SGOT]) ≤ 2.5 X institutional upper limit of normal
    • Alanine Aminotransferase (ALT) (Serum Pyruvic Glutamic Transaminase [SPGT]) ≤ 2.5 X institutional upper limit of normal
    • creatinine within normal institutional limits
  • Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days following completion of therapy. Should a woman or partner become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician and the investigator immediately.

  • A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

    • Has not undergone a hysterectomy or bilateral oophorectomy; or
    • Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)

Exclusion Criteria:

  • Subjects meeting any of the exclusion criteria at baseline will be excluded from study participation.
  • Current or anticipated use of other investigational agents. NOTE the following clarification for this study: Prohibited Concurrent Therapy:

Participation in clinical trials with other investigational agents that are not included in this trial, within 14 days of the start of this trial until 2 weeks after participant has received the last dose of bortezomib for mobilization.

  • Hypersensitivity to bortezomib, boron or mannitol or Granulocyte colony-stimulating factor (G-CSF)
  • Subject has received > 6 months of lenalidomide (Revlimid®) therapy prior to stem cell collection
  • Subject has known brain metastases. Presence of brain metastases should be excluded from this clinical trial because of poor prognosis and because patients often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  • Grade 3 or higher peripheral neuropathy
  • Bilirubin levels > 1.5 ULN

  • Uncontrolled inter-current illness including, but not limited to

    • ongoing or active infection
    • symptomatic congestive heart failure
    • unstable angina pectoris
    • cardiac arrhythmia
    • psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant or nursing: There is a potential for congenital abnormalities and for this regimen to harm nursing infants.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Stem cell collection without in-vivo purging with Bortezomib

Standard of Care Stem cell collection without in-vivo purging with Bortezomib. Standard of Care drugs Granulocyte colony-stimulating factor (G-CSF) +/- Mozobil (the latter if needed).

NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B
Drug: Granulocyte colony-stimulating factor (G-CSF)
Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed.
Other Names:
  • filgrastim
  • Zarxio
  • NEUPOGEN
  • filgrastim-sndz
Drug: Mozobil
Mozobil will be given to all participants by injection under the skin only if needed per Investigator.
Other Names:
  • plerixafor
Experimental: Stem cell collection with in-vivo purging with Bortezomib

Bortezomib will be given subcutaneously (SQ) at 1.3 mg/m2 on day -11 and day -8 followed by Granulocyte colony-stimulating factor (G-CSF) given SQ on day -4 thru day -1 and continued until the collection is completed. Mozobil will be given if needed.

There must be at least 72 hours between each dose of bortezomib. NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B
Drug: Granulocyte colony-stimulating factor (G-CSF)
Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed.
Other Names:
  • filgrastim
  • Zarxio
  • NEUPOGEN
  • filgrastim-sndz
Drug: Mozobil
Mozobil will be given to all participants by injection under the skin only if needed per Investigator.
Other Names:
  • plerixafor
Drug: Bortezomib
Bortezomib will be given to Group B participants by injection under the skin 11 days and 8 days before stem cell collection.
Other Names:
  • VELCADE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Multiparametric Flow Cytometry - Minimum Residual Disease
Time Frame: Day 0 for all subjects (Day 0 is the day of stem cell collection)
Estimate the proportion of subjects with plasma cell contamination (defined as >0.01% and at least 100 cellular events) of harvested stem cell product by multi parametric flow cytometry (MFC) from patients with myeloma undergoing autologous stem cell collection 1) by standard of care mobilization using Granulocyte colony-stimulating factor (G-CSF) with or without Mozobil and 2) after two doses of bortezomib as in vivo purging plus standard of care using G-CSF with or without Mozobil.
Day 0 for all subjects (Day 0 is the day of stem cell collection)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Multiparametric Flow Cytometry - Cluster of Differentiation 34 (CD34)Assessment
Time Frame: Within the first 30 days after stem cell collection
Estimate the proportion of subjects who have a successful collection of stem cells (> 2 million Cluster of Differentiation 34 (CD34) cells/Kg of body weight) for autologous transplant in both treatment groups.
Within the first 30 days after stem cell collection
Cluster of Differentiation 34 (CD34) Enumeration
Time Frame: Within the first 30 days after stem cell collection
Estimate the percentage of Cluster of Differentiation 34 (CD34) positive cells in circulating peripheral blood as a measure of mobilization on the days of collection.
Within the first 30 days after stem cell collection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Siddhartha Ganguly

Investigators

  • Principal Investigator: Siddhartha Ganguly, MD, The University of Kansas - Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

October 4, 2019

Study Completion (Actual)

April 8, 2020

Study Registration Dates

First Submitted

February 18, 2016

First Submitted That Met QC Criteria

March 8, 2016

First Posted (Estimate)

March 9, 2016

Study Record Updates

Last Update Posted (Actual)

June 18, 2021

Last Update Submitted That Met QC Criteria

May 24, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-IIT-BMT-MM-AutoSCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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