Chemotherapy and G-CSF for Mobilization

Multiple Myeloma Clinical Trial

— MOCCCA  

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).

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03442673
• Other study ID #: MOCCCA-Trial
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: September 17, 2018
• Est. completion date: May 2024

Study information

• Verified date: February 2023
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 137
• Est. completion date: May 2024
• Est. primary completion date: February 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Vinorelbine
Stimulation with vinorelbine together with G-CSF for mobilization of autologous stem cells
• Gemcitabine
Stimulation with gemcitabine together with G-CSF for mobilization of autologous stem cells
• G-CSF
Cytokine stimulation with G-CSF for mobilization of autologous stem cells

Locations

Country	Name	City	State
Switzerland	Department for Medical Oncology University Hospital/Inselspital	Berne

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients achieving a sufficient number of stem cells	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	Adverse events	Number of patients experiencing toxicities/adverse events assessed according to the CTCAE 5.0 during the study period	30 days after ASCT
Secondary	Quality of life	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
Secondary	Pain	Assessment of pain associated with the mobilization procedure. Pain is measured with visual analogue scale before and after mobilization	8 days
Secondary	Use of plerixafor	Number of patients requiring plerixafor for mobilization	8 days
Secondary	Hematologic engraftment after ASCT	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
Secondary	Cellular composition of the peripheral blood and the grafts	Standard multiparameter flowcytometric assessment will determine CD4, CD8, sCD3, CD56 and CD19 cellular subsets.	30 days
Secondary	Flowcytometric MRD levels in the peripheral blood and the grafts	Assessed by standard multiparameter flowcytometry.	30 days
Secondary	Overall survival	Time from ASCT until death of any cause or date of last follow-up.	60 months
Secondary	Progression free survival	Time from ASCT until first recurrence of myeloma or date of last follow-up whatever occurs first.	60 months