Multiple MyelomaPhase 2FMG-MM02NCT01790737
First Line Treatment Trial in Multiple Myeloma, Finnish Myeloma Group- Multiple Myeloma 02
A Phase 2 study testing Cyclophosphamide and Filgrastim in people with Multiple Myeloma, run by Kuopio University Hospital at 12 sites in Finland.
Trial summary
The purpose of this study is to determinate the efficacy and safety of the 3-drug induction treatment (RVD; lenalidomide plus bortezomib plus dexamethasone)followed by randomized autologous stem cell mobilization, autologous stem cell transplantation and lenalidomide maintenance. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Cyclophosphamide and Filgrastim
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 12 sitesFinland
- Study dates
- Jan 2013to 26 Feb 2019
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- written informed consent
- symptomatic, previously untreated International Stating System (ISS) 1-3 myeloma
- measurable disease
- WHO perf status 0-3
- eligible for ASCT
Who cannot join
- previously treated
- peripheral neuropathy gr >/= 2
- significant hepatic dysfunction
- severe cardiac dysfunction
- severe renal failure if not in dialysis
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Finland12 sites
Kanta-Häme Central Hospital
Hämeenlinna
Helsinki University Hospital
Helsinki
Jyväskylä Central Finland Central Hospital
Jyväskylä
Kainuu Kajaani Central Hospital
Kajaani
Länsi-Pohja Central Hospital
Kemi
Kymenlaakso Central Hospital
Kotka
Kuopio University Hospital
Kuopio, Northern Savonia, 70200
Mikkeli Southern-Savo Central Hospital
Mikkeli
Oulu University Hospital
Oulu
Satakunta Central Hospital
Pori
Tampere University Hospital
Tampere, Pirkanmaa, 33100
Turku University Central Hospital
Turku
About this study
Official title: A Prospective Phase II Study to Assess Immunophenotypic Remission After 3-drug Induction Followed by Randomized Stem Cell Mobilization, Autologous Stem Cell Transplantation (ASCT) and Lenalidomide Maintenance in Newly Diagnosed Multiple Myeloma
The purpose of this study is to determinate the efficacy and safety of the 3-drug induction treatment (RVD; lenalidomide plus bortezomib plus dexamethasone)followed by randomized autologous stem cell mobilization, autologous stem cell transplantation and lenalidomide maintenance. Primary endpoint is the immunophenotypic remission rate.During the randomized mobilization phase two active comparator arms Cyclophosphamide (CY)2g/m2 + Granulocyte-colony stimulating factor(G-CSF) vrs G-CSF will be compared regarding efficacy, costs and safety.
- Conditions
- Multiple Myeloma
- Being tested
- Cyclophosphamide, Filgrastim
- Keywords
- myeloma, stem cell mobilization, autologous stem cell transplantation, induction treatment, maintenance treatment
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
FilgrastimDrug
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Cyclophosphamide plus filgrastim Receives: Drug: Cyclophosphamide |
| B | Active comparator | Filgrastim Receives: Drug: Filgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunophenotypic response
Response will be measured by International Myeloma Working Group (IMWG) guidelines, and if the response is stringent CR and immunophenotypic remission, those patients will be followed also by allele-spesific oligonucleotide-polymerase chain reaction assay (ASO-PCR) to find out molecular remission rate.
Measured: Change from the start of induction treatment at 3 months, change from the start of induction at 6 months, at 9 months, at 12 months, at 16 months, at 20 months, at 24 moths
Secondary outcomes (1)
Progression free survival
Measured: From date of inclusion until the date of first documented progression or date of death from any cause whatever come first assessed up to last patient 2 years on maintenance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2013 (estimated)
- Study startJan 2013
- Primary completion10 Oct 2018
- Study completion26 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helsinki University Central Hospital, Tampere University Hospital, Turku University Hospital, Oulu University Hospital, Mikkeli Central Hospital, Kymenlaakso Central Hospital Kotka Finland, Jyväskylä Central Hospital, Kanta-Häme Central Hospital, Satakunta Central Hospital, Kainuu Central Hospital, Kajaani, Celgene Corporation
- Responsible party
- Sponsor
- Investigators
- Raija Silvennoinen, MD, Principal investigator, Kuopio University Hospital, Kuopio, FI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01790737
- Sponsor's protocol ID
- KUH5101424
- Other IDs
- 2012-001051-39
- Acronym
- FMG-MM02
- Status last verified
- Feb 2019
- First submitted
- 4 Feb 2013
- Last updated
- 1 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Phase II Study to Assess Immunophenotypic Remission After 3-drug Induction Followed by Randomized Stem Cell Mobilization, Autologous Stem Cell Transplantation (ASCT) and Lenalidomide Maintenance in Newly Diagnosed Multiple Myeloma
- ClinicalTrials.gov ID
- NCT01790737
- Acronym / sponsor ID
- FMG-MM02 / KUH5101424
- Conditions
- Multiple Myeloma
- Keywords
- myeloma, stem cell mobilization, autologous stem cell transplantation, induction treatment, maintenance treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Collaborators
- Helsinki University Central Hospital, Tampere University Hospital, Turku University Hospital, Oulu University Hospital, Mikkeli Central Hospital, Kymenlaakso Central Hospital Kotka Finland, Jyväskylä Central Hospital, Kanta-Häme Central Hospital, Satakunta Central Hospital, Kainuu Central Hospital, Kajaani, Celgene Corporation
- Study start
- Jan 2013
- Primary completion
- 10 Oct 2018 (actual)
- Study completion
- 26 Feb 2019 (actual)
- First posted
- 13 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determinate the efficacy and safety of the 3-drug induction treatment (RVD; lenalidomide plus bortezomib plus dexamethasone)followed by randomized autologous stem cell mobilization, autologous stem cell transplantation and lenalidomide maintenance. Primary endpoint is the immunophenotypic remission rate.During the randomized mobilization phase two active comparator arms Cyclophosphamide (CY)2g/m2 + Granulocyte-colony stimulating factor(G-CSF) vrs G-CSF will be compared regarding efficacy, costs and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: CyclophosphamideCyclophosphamide plus filgrastim |
| B | Active comparator | Drug: FilgrastimFilgrastim |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- written informed consent
- symptomatic, previously untreated International Stating System (ISS) 1-3 myeloma
- measurable disease
- WHO perf status 0-3
- eligible for ASCT
Key exclusion criteria (5 listed)
- previously treated
- peripheral neuropathy gr >/= 2
- significant hepatic dysfunction
- severe cardiac dysfunction
- severe renal failure if not in dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyclophosphamide | Drug | A |
| Filgrastim | Drug | B |
Primary outcome
Immunophenotypic response
Time frame: Change from the start of induction treatment at 3 months, change from the start of induction at 6 months, at 9 months, at 12 months, at 16 months, at 20 months, at 24 moths
Response will be measured by International Myeloma Working Group (IMWG) guidelines, and if the response is stringent CR and immunophenotypic remission, those patients will be followed also by allele-spesific oligonucleotide-polymerase chain reaction assay (ASO-PCR) to find out molecular remission rate.
1 secondary outcome
Progression free survival
Time frame: From date of inclusion until the date of first documented progression or date of death from any cause whatever come first assessed up to last patient 2 years on maintenance
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raija Silvennoinen, MD principal investigator
Kuopio University Hospital, Kuopio, FI
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cyclophosphamide and Filgrastim in people with Multiple Myeloma, run by Kuopio University Hospital at 12 sites in Finland.
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 5 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 1 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Finland. 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?
Immunophenotypic response (time frame: Change from the start of induction treatment at 3 months, change from the start of induction at 6 months, at 9 months, at 12 months, at 16 months, at 20 months, at 24 moths). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Mar 2019.