- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03442673
Chemotherapy and G-CSF for Mobilization (MOCCCA)
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).
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Berne, Switzerland, 3010
- Department for Medical Oncology University Hospital/Inselspital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
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: 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.
|
Stimulation with vinorelbine together with G-CSF for mobilization of autologous stem cells
Stimulation with gemcitabine together with G-CSF for mobilization of autologous stem cells
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.
|
Cytokine stimulation with G-CSF for mobilization of autologous stem cells
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
8 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
30 days after ASCT
|
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
|
8 days
|
Pain
Time Frame: 8 days
|
Assessment of pain associated with the mobilization procedure.
Pain is measured with visual analogue scale before and after mobilization
|
8 days
|
Use of plerixafor
Time Frame: 8 days
|
Number of patients requiring plerixafor for mobilization
|
8 days
|
Hematologic engraftment after ASCT
Time Frame: 30 days
|
First day (after ASCT) of neutrophils rising again above 0.5 G/l, and of platelets rising again above 20 G/L in the absence of platelet transfusions in the previous 3 days.
|
30 days
|
Cellular composition of the peripheral blood and the grafts
Time Frame: 30 days
|
Standard multiparameter flowcytometric assessment will determine CD4, CD8, sCD3, CD56 and CD19 cellular subsets.
|
30 days
|
Flowcytometric MRD levels in the peripheral blood and the grafts
Time Frame: 30 days
|
Assessed by standard multiparameter flowcytometry.
|
30 days
|
Overall survival
Time Frame: 60 months
|
Time from ASCT until death of any cause or date of last follow-up.
|
60 months
|
Progression free survival
Time Frame: 60 months
|
Time from ASCT until first recurrence of myeloma or date of last follow-up whatever occurs first.
|
60 months
|
Collaborators and Investigators
Investigators
- Study Chair: Barbara Jeker, MD, Department for Medical Oncology University Hospital/Inselspital 3010 Bern Switzerland
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Gemcitabine
- Vinorelbine
Other Study ID Numbers
- MOCCCA-Trial
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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