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Multiple MyelomaPhase 2MOCCCANCT03442673

Chemotherapy and G-CSF for Mobilization

A Phase 2 study testing Vinorelbine, Gemcitabine and G-CSF in people with Multiple Myeloma, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Vinorelbine, Gemcitabine and G-CSF
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
137 participants
Where
1 siteSwitzerland
Study dates
17 Sep 2018to 1 May 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Department for Medical Oncology University Hospital/Inselspital

    Bern, 3010

Other trials in Switzerland

About this study

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).

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.

Read the 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.

Being tested
Vinorelbine, Gemcitabine, G-CSF
Keywords
Multiple Myeloma, Vinorelbine, Gemcitabine, G-CSF, ASCT
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VinorelbineDrug

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

  • GemcitabineDrug

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

  • G-CSFDrug

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

Study groups in NCT03442673
Study groupRoleWhat they receive
CG (Chemotherapy/G-CSF) - RegimeActive comparatorVinorelbine 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.
Receives: Drug: Vinorelbine; Drug: Gemcitabine; Drug: G-CSF
G (G-CSF) - RegimeExperimentalG-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.
Receives: Drug: G-CSF

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 8 days

Secondary outcomes (9)

  1. Adverse events

    Number of patients experiencing toxicities/adverse events assessed according to the CTCAE 5.0 during the study period

    Measured: 30 days after ASCT

  2. 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

    Measured: 8 days

  3. Pain

    Assessment of pain associated with the mobilization procedure. Pain is measured with visual analogue scale before and after mobilization

    Measured: 8 days

  4. Use of plerixafor

    Number of patients requiring plerixafor for mobilization

    Measured: 8 days

  5. 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.

    Measured: 30 days

  6. Cellular composition of the peripheral blood and the grafts

    Standard multiparameter flowcytometric assessment will determine CD4, CD8, sCD3, CD56 and CD19 cellular subsets.

    Measured: 30 days

  7. Flowcytometric MRD levels in the peripheral blood and the grafts

    Assessed by standard multiparameter flowcytometry.

    Measured: 30 days

  8. Overall survival

    Time from ASCT until death of any cause or date of last follow-up.

    Measured: 60 months

  9. Progression free survival

    Time from ASCT until first recurrence of myeloma or date of last follow-up whatever occurs first.

    Measured: 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2018
  2. Study start17 Sep 2018
  3. Primary completion1 Mar 2023
  4. Study completion1 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
137 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03442673
Sponsor's protocol ID
MOCCCA-Trial
Acronym
MOCCCA
Status last verified
Mar 2025
First submitted
16 Feb 2018
Last updated
28 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 39548306

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vinorelbine, Gemcitabine and G-CSF in people with Multiple Myeloma, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients achieving a sufficient number of stem cells (time frame: 8 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03442673, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.

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Chemotherapy and G-CSF for Mobilization (NCT03442673) | AzTrials