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Chemotherapy and G-CSF for Mobilization (MOCCCA)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03442673
Recruitment Status : Recruiting
First Posted : February 22, 2018
Last Update Posted : January 14, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Tracking Information
First Submitted Date  ICMJE February 16, 2018
First Posted Date  ICMJE February 22, 2018
Last Update Posted Date January 14, 2020
Actual Study Start Date  ICMJE September 17, 2018
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2018)
Number of patients achieving a sufficient number of stem cells [ Time Frame: 8 days ]
Number of patients achieving a sufficient number (at least 5.0 Mio/kg) of stem cells at the planned day in a single day procedure without the use of the rescue compound plerixafor
Original Primary Outcome Measures  ICMJE
 (submitted: February 16, 2018)
Non-inferiority of G-CSF stimulation alone compared to the combined chemotherapy/G-CSF stimulation.chemotherapy stimulation with vinorelbine or gemcitabine together with G-CSF for mobilization of autologous stem cells in myeloma patients. [ Time Frame: 8 days ]
Number of patients achieving a sufficient number (at least 5.0 Mio/kg) of stem cells at the planned day in a single day procedure without the use of the rescue compound plerixafor
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 31, 2018)
  • Adverse events [ Time Frame: 30 days after ASCT ]
    Number of patients experiencing toxicities/adverse events assessed according to the CTCAE 5.0 during the study period
  • Quality of life [ Time Frame: 8 days ]
    Assessment of quality of life before and after mobilization. The EORTC Q30 questionnaire will be given to patients at screening and after mobilization
  • Pain [ Time Frame: 8 days ]
    Assessment of pain associated with the mobilization procedure. Pain is measured with visual analogue scale before and after mobilization
  • Use of plerixafor [ Time Frame: 8 days ]
    Number of patients requiring plerixafor for mobilization
Original Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2018)
  • Adverse events [ Time Frame: 30 days after ASCT ]
    Number of patients experiencing toxicities/adverse events assessed according to the CTCAE 5.0 during the study period
  • Quality of life [ Time Frame: 8 days ]
    Assessment of quality of life before and after mobilization. The The EORTC Q30 questionnaire will be given to patients at screening and after mobilization
  • Pain [ Time Frame: 8 days ]
    Assessment of pain associated with the mobilization procedure. Pain is measured with visual analogue scale before and after mobilization
  • Use of plerixafor [ Time Frame: 8 days ]
    Number of patients requiring plerixafor for mobilization
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Chemotherapy and G-CSF for Mobilization
Official Title  ICMJE A Randomized Phase II Trial Comparing Stem Cell Mobilization With Chemotherapy and Cytokine (G-CSF) Versus Cytokine (G-CSF) Alone in Myeloma Patients (MOCCCA-trial).
Brief Summary This study aims to demonstrate that the mobilization with cytokine stimulation with G-CSF alone is non-inferior as compared to the standard mobilization with chemotherapy and G-CSF while associated with fewer side effects in myeloma patients.
Detailed Description

Background and Rationale High-dose chemotherapy (HDCT) with melphalan and autologous stem cell transplantation (ASCT) remains an integral component of the myeloma treatment algorithm for patients considered eligible for the procedure, nowadays performed in myeloma patients up to the age of 75 years. Until the advent of the novel agents, the initial therapy regimens commonly used were vincristine, doxorubicin, and dexamethasone (VAD) or single-agent dexamethasone, both of which shared the advantage of having little impact on stem cell mobilization and collection. Previous studies had shown that alkylating agents can potentially affect the stem cell pool and thus interfere with the ability to collect adequate numbers of stem cells. However, VAD is no longer uses nowadays, whereas current lenalidomide-containing combinations significantly affect stem cell collection. .In Switzerland, the combination of non-myeloablative chemotherapy with vinorelbine or gemcitabine and G-CSF is the current standard procedure. With the predominant use of bortezomib during induction treatment more patients have pre-existing neurotoxicity. Vinorelbine can aggravate this problem. Recently data have shown that a mobilization with gemcitabine together with G-CSF is safe and effective in myeloma patients. Whether chemotherapy is mandatory at all to achieve the same reliable and cost-effective mobilization is currently unknown. The investigators therefore consider that a direct comparison between vinorelbine/gemcitabine and G-CSF versus G-CSF alone is justified.

Objective:

The primary objective is to show non-inferiority of cytokine stimulation with G-CSF compared to chemotherapy stimulation with vinorelbine (or gemcitabine) together with G-CSF for the mobilization of autologous stem cells in myeloma patients in first remission.

Study Duration:

The anticipated total study duration is 42 months.

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: Vinorelbine
    Stimulation with vinorelbine together with G-CSF for mobilization of autologous stem cells
  • Drug: Gemcitabine
    Stimulation with gemcitabine together with G-CSF for mobilization of autologous stem cells
  • Drug: G-CSF
    Cytokine stimulation with G-CSF for mobilization of autologous stem cells
Study Arms  ICMJE
  • Active Comparator: CG (Chemotherapy/G-CSF) - Regime
    Vinorelbine 35 mg/m2 at day 1 as an i.v. infusion over 10 minutes or gemcitabine 1250 mg/m2 as a 30 minutes infusion at day 1. G-CSF will be started at day 4 at 10mcg/kg b.w. split in two daily doses, until the end of the stem cell collection procedure, with the first collection attempt on day 8.
    Interventions:
    • Drug: Vinorelbine
    • Drug: Gemcitabine
    • Drug: G-CSF
  • Experimental: G (G-CSF) - Regime
    G-CSF at 10mcg/kg b.w. split in two daily doses starting from day 1 until the end of the stem cell collection procedure, with the first collection attempt on day 5.
    Intervention: Drug: G-CSF
Publications * Not Provided

*   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: September 26, 2018)
136
Original Estimated Enrollment  ICMJE
 (submitted: February 16, 2018)
132
Estimated Study Completion Date  ICMJE May 2024
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Myeloma or amyloidosis patients after standard first-line induction treatment. (Additional induction regimens in refractory myeloma patients are allowed)
  • Patients must be considered being clinically fit for subsequent consolidation with high-dose melphalan-based chemotherapy with autologous stem cell support.
  • Patients must be aged ≥18 years.
  • Female patients of child-bearing potential must have a negative pregnancy test (urine or serum) within 14 days prior to study treatment mobilisation, and they must implement adequate measures (hormonal treatment p.o. or i.m., intra uterine surgical devices, or latex condoms) to avoid pregnancy during study treatment and for additional 12 months.
  • Patients must have given voluntary written informed consent

Exclusion Criteria:

  • Patients with concurrent other malignant disease can be included, but previous treatment for other malignancies must have been terminated at least 2 months before registration. Endocrine treatment (such as for breast cancer) is allowed.
  • Pregnancy or lactating female patients.
  • The use of any anti-cancer investigational agents within 14 days prior to the expected start of trial treatment.
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: Barbara Jeker, MD +41 31 632 41 95 barbara.jeker@insel.ch
Contact: Thomas Pabst, MD +41 31 632 84 30 thomas.pabst@insel.ch
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03442673
Other Study ID Numbers  ICMJE MOCCCA-Trial
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital Inselspital, Berne
Study Sponsor  ICMJE University Hospital Inselspital, Berne
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Barbara Jeker, MD Department for Medical Oncology University Hospital/Inselspital 3010 Bern Switzerland
PRS Account University Hospital Inselspital, Berne
Verification Date January 2020

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