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Chemotherapy and G-CSF for Mobilization (MOCCCA)

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ClinicalTrials.gov Identifier: NCT03442673
Recruitment Status : Recruiting
First Posted : February 22, 2018
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Vinorelbine Drug: Gemcitabine Drug: G-CSF Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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).
Actual Study Start Date : September 17, 2018
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
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.
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

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.
Drug: G-CSF
Cytokine stimulation with G-CSF for mobilization of autologous stem cells




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Pain [ Time Frame: 8 days ]
    Assessment of pain associated with the mobilization procedure. Pain is measured with visual analogue scale before and after mobilization

  4. Use of plerixafor [ Time Frame: 8 days ]
    Number of patients requiring plerixafor for mobilization



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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:

  • 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.

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): NCT03442673


Contacts
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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

Locations
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Switzerland
Department for Medical Oncology University Hospital/Inselspital Recruiting
Berne, Switzerland, 3010
Contact: Barbara Jeker, MD       barbara.jeker@insel.ch   
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Study Chair: Barbara Jeker, MD Department for Medical Oncology University Hospital/Inselspital 3010 Bern Switzerland

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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT03442673     History of Changes
Other Study ID Numbers: MOCCCA-Trial
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital Inselspital, Berne:
Multiple Myeloma
Vinorelbine
Gemcitabine
G-CSF
ASCT

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
Gemcitabine
Vinorelbine
Lenograstim
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Antineoplastic Agents, Phytogenic
Tubulin Modulators