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

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ClinicalTrials.gov Identifier: NCT02703779
Recruitment Status : Recruiting
First Posted : March 9, 2016
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Siddhartha Ganguly, University of Kansas Medical Center

Tracking Information
First Submitted Date  ICMJE February 18, 2016
First Posted Date  ICMJE March 9, 2016
Last Update Posted Date May 2, 2018
Actual Study Start Date  ICMJE March 2016
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02703779 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2016)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exploratory Trial to Estimate Proportion of Patients With Tumor Cell Contaminated Leukapheresis Products With and Without Bortezomib With In-vivo Purging - Multiple Myeloma (MM)
Official Title  ICMJE 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
Brief Summary Explore stem cell collection with or without bortezomib with in-vivo purging in multiple myeloma.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE
  • 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 Name: VELCADE
  • 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:
    • NEUPOGEN
    • filgrastim
    • filgrastim-sndz
    • Zarxio
  • Drug: Mozobil
    Mozobil will be given to all participants by injection under the skin only if needed per Investigator.
    Other Name: plerixafor
Study Arms  ICMJE
  • 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

    Interventions:
    • Drug: Granulocyte colony-stimulating factor (G-CSF)
    • Drug: Mozobil
  • 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

    Interventions:
    • Drug: Bortezomib
    • Drug: Granulocyte colony-stimulating factor (G-CSF)
    • Drug: Mozobil
Publications * Rawstron AC, Orfao A, Beksac M, Bezdickova L, Brooimans RA, Bumbea H, Dalva K, Fuhler G, Gratama J, Hose D, Kovarova L, Lioznov M, Mateo G, Morilla R, Mylin AK, Omedé P, Pellat-Deceunynck C, Perez Andres M, Petrucci M, Ruggeri M, Rymkiewicz G, Schmitz A, Schreder M, Seynaeve C, Spacek M, de Tute RM, Van Valckenborgh E, Weston-Bell N, Owen RG, San Miguel JF, Sonneveld P, Johnsen HE; European Myeloma Network. Report of the European Myeloma Network on multiparametric flow cytometry in multiple myeloma and related disorders. Haematologica. 2008 Mar;93(3):431-8. doi: 10.3324/haematol.11080. Epub 2008 Feb 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 8, 2016)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2019
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kerry Hepler ctnursenav@kumc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02703779
Other Study ID Numbers  ICMJE 2015-IIT-BMT-MM-AutoSCT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Siddhartha Ganguly, University of Kansas Medical Center
Study Sponsor  ICMJE Siddhartha Ganguly
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Siddhartha Ganguly, MD The University of Kansas - Cancer Center
PRS Account University of Kansas Medical Center
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP