Chemotherapy and G-CSF for Mobilization

NCT03442673 | Completed Phase 2

• 1 other identifier: MOCCCA-Trial
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; Vinorelbine; Gemcitabine; G-CSF; ASCT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Adverse events

  30 days after ASCT

• Quality of life

  8 days

• Pain

  8 days

• Use of plerixafor

  8 days

• Hematologic engraftment after ASCT

  30 days

Study Arms (2)

CG (Chemotherapy/G-CSF) - Regime

ACTIVE COMPARATOR

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; Drug: Gemcitabine; Drug: G-CSF

G (G-CSF) - Regime

EXPERIMENTAL

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

Interventions

Vinorelbine DRUG

Stimulation with vinorelbine together with G-CSF for mobilization of autologous stem cells

CG (Chemotherapy/G-CSF) - Regime

Gemcitabine DRUG

Stimulation with gemcitabine together with G-CSF for mobilization of autologous stem cells

CG (Chemotherapy/G-CSF) - Regime

G-CSF DRUG

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

CG (Chemotherapy/G-CSF) - Regime; G (G-CSF) - Regime

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Department for Medical Oncology University Hospital/Inselspital

Bern, 3010, Switzerland

Location

Related Publications (1)

• Jeker B, Thalmann L, Bacher U, Nilius H, Rhyner G, Sokler M, Soltermann S, Winkler A, Vorburger C, Daskalakis M, Hoffmann M, Pabst T. Comparing stem cell mobilization with chemotherapy and cytokine (G-CSF) versus cytokine alone in myeloma patients (MOCCCA): a randomized phase II, open-label, non-inferiority trial. Bone Marrow Transplant. 2025 Mar;60(3):270-276. doi: 10.1038/s41409-024-02468-z. Epub 2024 Nov 15.

  PMID: 39548306 DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Vinorelbine; Gemcitabine; Granulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Barbara Jeker, MD

  Department for Medical Oncology University Hospital/Inselspital 3010 Bern Switzerland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2018
• First Posted: February 22, 2018
• Study Start: September 17, 2018
• Primary Completion: March 1, 2023
• Study Completion: May 1, 2024
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

CH (1)