Clinical trial NCT03442673: Chemotherapy and G-CSF for Mobilization
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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Vinorelbine
Gemcitabine
G-CSF
ASCT
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2018-02-22
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Number of patients achieving a sufficient number of stem cells
timeFrame: 8 days
Secondary outcomes:
measure: Adverse events
timeFrame: 30 days after ASCT
measure: Quality of life
timeFrame: 8 days
measure: Pain
timeFrame: 8 days
measure: Use of plerixafor
timeFrame: 8 days
measure: Hematologic engraftment after ASCT
timeFrame: 30 days
measure: Cellular composition of the peripheral blood and the grafts
timeFrame: 30 days
measure: Flowcytometric MRD levels in the peripheral blood and the grafts
timeFrame: 30 days
measure: Overall survival
timeFrame: 60 months
measure: Progression free survival
timeFrame: 60 months
Other outcomes:
Locations:
city: Berne
country: Switzerland
facility: Department for Medical Oncology University Hospital/Inselspital
Study officials:
affiliation: Department for Medical Oncology University Hospital/Inselspital 3010 Bern Switzerland
name: Barbara Jeker, MD
role: STUDY_CHAIR
References: