Multiple MyelomaPhase 2ViGeMNCT02791373
Vinorelbine and Gemcitabine in Myeloma
A Phase 2 study testing Vinorelbine and Gemcitabine in people with Multiple Myeloma and Amyloidosis, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
The purpose of this study is to determine whether the efficacy of gemcitabine is comparable with the efficacy of the standard chemotherapy with vinorelbine for mobilization of autologous stem cells in myeloma patients Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Myeloma, Amyloidosis
- What is being tested?
- Vinorelbine and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2014to 31 Dec 2017
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic myeloma or amyloidosis patients after standard first-line induction treatment. Patients must be fit for subsequent consolidation with high-dose chemotherapy with melphalan with autologous stem cell support.
- Standard induction chemotherapy comprises regimens including thalidomide, bortezomib, or lenalidomide (less than 5 cycles), alone or in combination with dexamethasone. Combinations of novel agents are allowed as well as induction with the VAD (vincristine, adriamycin and dexamethasone) regimen.
- Patient must be aged 18-75 years, with an ECOG (Eastern Cooperative Oncology Group) < 3, and has given voluntary written informed consent.
- Patient has the following laboratory values at baseline:
- Platelets count > 50 x 109/l without transfusion support within 7 days before the laboratory test.
- Absolute neutrophil count (ANC) > 1.0 x 109/l without the use of colony stimulating factors.
- Creatinine-clearance > 40 ml/min
- Negative pregnancy test (urine or serum) within 14 days prior to registration for all women of childbearing potential. Patients of childbearing potential 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. No pregnant or lactating patients are allowed.
Who cannot join
- Patients with more than 4 cycles of chemotherapy with lenalidomide.
- Patients not fit for autologous stem cell transplantation
- Patients with other serious medical condition that could potentially interfere with the completion of treatment according to this protocol or that would impair tolerance to therapy or prolong hematological recovery.
- Subject is currently enrolled in another investigational trial or is receiving other investigational agent(s).
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department for Medical Oncology; University Hospital/Inselspital
Bern, 3010
About this study
Official title: A Randomized Evaluation of Vinorelbine Versus Gemcitabine for Mobilization of Peripheral Stem Cells in Myeloma Patients Undergoing Autologous Stem Cell Transplantation.
The purpose of this study is to determine whether the efficacy of gemcitabine is comparable with the efficacy of the standard chemotherapy with vinorelbine for mobilization of autologous stem cells in myeloma patients
Read the detailed description
Mobilization and engraftment of autologous peripheral blood progenitor cells (PBPC) in newly diagnosed multiple myeloma (MM) or amyloidosis patients followed by high dose chemotherapy with PBPC support.
Eligible are symptomatic myeloma or amyloidosis patients after standard first-line induction treatment. Patients must be fit for subsequent consolidation with high-dose chemotherapy with melphalan with autologous stem cell support.
Chemotherapy with vinorelbine is given at a standard dose of 35mg/m2 i.v. at day 1 as an infusion over 10 minutes, on an ambulatory basis. Gemcitabine is given at the standard dose of 1250 mg/m2 i.v. in 500ml NaCl 0.9% (sodium chlorid) as an infusion over 30 minutes, on an ambulatory basis.
G-CSF (granulocyte-colony stimulating factor) is given at 60 Mio s.c./d for patients ≤ 69kg in two daily doses of 30 Mio 12 hours apart, at 78 Mio s.c./d for patients from 70kg to 89kg with 48 Mio given in the morning and 30 Mio given in the evening, and at 96 Mio s.c./d for patients ≥ 90kg in two daily doses of 48 Mio.
Patients will be randomized in a 1:1 ratio between vinorelbine and gemcitabine mobilization. Patients will be stratified according to (A) response to induction treatment (refractory/stable disease/partial response versus very good partial response/complete response) and (B) peripheral neuropathy present versus absent before mobilization.
The high dose chemotherapy supported by autologous stem cell transplantation is not part of the study treatment. Standard high dose melphalan (200 mg/m2) will be used as conditioning regimen. After transplantation, G-CSF will be given to subjects starting at day +6 until day +11 after PBPC re-infusion, at a dose of 30 Mio per day for patients ≤ 75kg, and of 48 Mio for patients >75kg.
Planned accrual is chemotherapy with vinorelbine is given at a standard dose of 35mg/m2 i.v. at day 1 as an infusion over 10 minutes, on an ambulatory basis. Gemcitabine is given at the standard dose of 1250 mg/m2 i.v. in 500ml NaCl 0.9% as an infusion over 30 minutes, on an ambulatory basis.
G-CSF is given at 60 Mio s.c./d for patients ≤ 69kg in two daily doses of 30 Mio 12 hours apart, at 78 Mio s.c./d for patients from 70kg to 89kg with 48 Mio given in the morning and 30 Mio given in the evening, and at 96 Mio s.c./d for patients ≥ 90kg in two daily doses of 48 Mio.
Patients will be randomized in a 1:1 ratio between vinorelbine and gemcitabine mobilization. Patients will be stratified according to (A) response to induction treatment (refractory/stable disease/partial response versus very good partial response/complete response) and (B) peripheral neuropathy present versus absent before mobilization.
The high dose chemotherapy supported by autologous stem cell transplantation is not part of the study treatment. Standard high dose melphalan (200 mg/m2) will be used as conditioning regimen. After transplantation, G-CSF will be given to subjects starting at day +6 until day +11 after PBPC re-infusion, at a dose of 30 Mio per day for patients ≤ 75kg, and of 48 Mio for patients >75kg.
Planed accrual of 136 patients in 42 months.
- Conditions
- Multiple Myeloma, Amyloidosis
- Being tested
- Vinorelbine, Gemcitabine
- Medical subject headings
- Multiple Myeloma, Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VinorelbineDrug
Also called Navelbine
Mobilisation Chemotherapy
GemcitabineDrug
Also called Gemcitabine Sandoz
Mobilisation Chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Mobilisation Chemotherapy: Vinorelbine | Active comparator | Vinorelbine is given at a standard dose of 35mg/m2 i.v. at day 1 as an infusion over 10 minutes, on an ambulatory basis. Receives: Drug: Vinorelbine |
| Mobilisation Chemotherapy: Gemcitabine | Experimental | Gemcitabine is given at the standard dose of 1250 mg/m2 i.v. in 500ml NaCl 0.9% (sodium chloride) as an infusion over 30 minutes, on an ambulatory basis. Receives: Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
CD34+ (cluster of differentiation 34) peripheral blood stem cells
Number of patients with collection of > 6 million CD34+ peripheral blood stem cells/kg body weight at day 8 after vinorelbine versus gemcitabine chemotherapy
Measured: Day 8
Secondary outcomes (6)
Rate of peripheral neuropathy
Number of patients with peripheral neuropathy following mobilization chemotherapy with vinorelbine versus gemcitabine. Clinical assessment will be done between 15 and 30 days after autologous transplant
Measured: Between 15 and 30 days
Severity of peripheral neuropathy
Grade of peripheral neuropathy following mobilization chemotherapy with vinorelbine versus gemcitabine. Clinical assessment will be done between 15 and 30 days after autologous transplant
Measured: Between 15 and 30 days
Hematologic recovery
Time (days) until hematologic recovery (Leucocytes > 3.0 G/L and Thrombocytes >100 G/L) following autologous transplantation comparing patients mobilized with vinorelbine versus gemcitabine.
Measured: Between 15 and 30 days
Minimal residual disease in the peripheral blood
Minimal residual disease in the peripheral blood at the day of stem cell collection (day 8) using flow cytometry multiparameter assessment comparing patients mobilized with vinorelbine versus gemcitabine.
Measured: Day 8
Need to use the stem cell releasing compound Plerixafor
Number of patients who needs to use the stem cell releasing compound Plerixafor at day 9 in patients with insufficient peripheral stem cell mobilization (at day 8) comparing patients mobilized with vinorelbine versus gemcitabine.
Measured: Day 8
Response Rate
Response (myeloma parameter) to the mobilization chemotherapy comparing patients mobilized with vinorelbine versus gemcitabine.
Measured: Between 15 and 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2016 (estimated)
- Study startMar 2014
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Pabst, MD, Study chair, Inselspital , University Hospital Berne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02791373
- Sponsor's protocol ID
- ViGeM
- Acronym
- ViGeM
- Status last verified
- Mar 2018
- First submitted
- 1 Jun 2016
- Last updated
- 3 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Attal M, Harousseau JL, Stoppa AM, Sotto JJ, Fuzibet JG, Rossi JF, Casassus P, Maisonneuve H, Facon T, Ifrah N, Payen C, Bataille R. A prospective, randomized trial of autologous bone marrow transplantation and chemotherapy in multiple myeloma. Intergroupe Francais du Myelome. N Engl J Med. 1996 Jul 11;335(2):91-7. doi: 10.1056/NEJM199607113350204.
PubMed 8649495
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Evaluation of Vinorelbine Versus Gemcitabine for Mobilization of Peripheral Stem Cells in Myeloma Patients Undergoing Autologous Stem Cell Transplantation.
- ClinicalTrials.gov ID
- NCT02791373
- Acronym / sponsor ID
- ViGeM / ViGeM
- Conditions
- Multiple Myeloma, Amyloidosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 6 Jun 2016 (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 determine whether the efficacy of gemcitabine is comparable with the efficacy of the standard chemotherapy with vinorelbine for mobilization of autologous stem cells in myeloma patients
Detailed description
Mobilization and engraftment of autologous peripheral blood progenitor cells (PBPC) in newly diagnosed multiple myeloma (MM) or amyloidosis patients followed by high dose chemotherapy with PBPC support.
Eligible are symptomatic myeloma or amyloidosis patients after standard first-line induction treatment. Patients must be fit for subsequent consolidation with high-dose chemotherapy with melphalan with autologous stem cell support.
Chemotherapy with vinorelbine is given at a standard dose of 35mg/m2 i.v. at day 1 as an infusion over 10 minutes, on an ambulatory basis. Gemcitabine is given at the standard dose of 1250 mg/m2 i.v. in 500ml NaCl 0.9% (sodium chlorid) as an infusion over 30 minutes, on an ambulatory basis.
G-CSF (granulocyte-colony stimulating factor) is given at 60 Mio s.c./d for patients ≤ 69kg in two daily doses of 30 Mio 12 hours apart, at 78 Mio s.c./d for patients from 70kg to 89kg with 48 Mio given in the morning and 30 Mio given in the evening, and at 96 Mio s.c./d for patients ≥ 90kg in two daily doses of 48 Mio.
Patients will be randomized in a 1:1 ratio between vinorelbine and gemcitabine mobilization. Patients will be stratified according to (A) response to induction treatment (refractory/stable disease/partial response versus very good partial response/complete response) and (B) peripheral neuropathy present versus absent before mobilization.
The high dose chemotherapy supported by autologous stem cell transplantation is not part of the study treatment. Standard high dose melphalan (200 mg/m2) will be used as conditioning regimen. After transplantation, G-CSF will be given to subjects starting at day +6 until day +11 after PBPC re-infusion, at a dose of 30 Mio per day for patients ≤ 75kg, and of 48 Mio for patients >75kg.
Planned accrual is chemotherapy with vinorelbine is given at a standard dose of 35mg/m2 i.v. at day 1 as an infusion over 10 minutes, on an ambulatory basis. Gemcitabine is given at the standard dose of 1250 mg/m2 i.v. in 500ml NaCl 0.9% as an infusion over 30 minutes, on an ambulatory basis.
G-CSF is given at 60 Mio s.c./d for patients ≤ 69kg in two daily doses of 30 Mio 12 hours apart, at 78 Mio s.c./d for patients from 70kg to 89kg with 48 Mio given in the morning and 30 Mio given in the evening, and at 96 Mio s.c./d for patients ≥ 90kg in two daily doses of 48 Mio.
Patients will be randomized in a 1:1 ratio between vinorelbine and gemcitabine mobilization. Patients will be stratified according to (A) response to induction treatment (refractory/stable disease/partial response versus very good partial response/complete response) and (B) peripheral neuropathy present versus absent before mobilization.
The high dose chemotherapy supported by autologous stem cell transplantation is not part of the study treatment. Standard high dose melphalan (200 mg/m2) will be used as conditioning regimen. After transplantation, G-CSF will be given to subjects starting at day +6 until day +11 after PBPC re-infusion, at a dose of 30 Mio per day for patients ≤ 75kg, and of 48 Mio for patients >75kg.
Planed accrual of 136 patients in 42 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobilisation Chemotherapy: Vinorelbine | Active comparator | Drug: VinorelbineVinorelbine is given at a standard dose of 35mg/m2 i.v. at day 1 as an infusion over 10 minutes, on an ambulatory basis. |
| Mobilisation Chemotherapy: Gemcitabine | Experimental | Drug: GemcitabineGemcitabine is given at the standard dose of 1250 mg/m2 i.v. in 500ml NaCl 0.9% (sodium chloride) as an infusion over 30 minutes, on an ambulatory basis. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Symptomatic myeloma or amyloidosis patients after standard first-line induction treatment. Patients must be fit for subsequent consolidation with high-dose chemotherapy with melphalan with autologous stem cell support.
- Standard induction chemotherapy comprises regimens including thalidomide, bortezomib, or lenalidomide (less than 5 cycles), alone or in combination with dexamethasone. Combinations of novel agents are allowed as well as induction with the VAD (vincristine, adriamycin and dexamethasone) regimen.
- Patient must be aged 18-75 years, with an ECOG (Eastern Cooperative Oncology Group) < 3, and has given voluntary written informed consent.
- Patient has the following laboratory values at baseline:
- Platelets count > 50 x 109/l without transfusion support within 7 days before the laboratory test.
Key exclusion criteria (4 listed)
- Patients with more than 4 cycles of chemotherapy with lenalidomide.
- Patients not fit for autologous stem cell transplantation
- Patients with other serious medical condition that could potentially interfere with the completion of treatment according to this protocol or that would impair tolerance to therapy or prolong hematological recovery.
- Subject is currently enrolled in another investigational trial or is receiving other investigational agent(s).
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 |
|---|---|---|
| VinorelbineAlso: NavelbineMobilisation Chemotherapy | Drug | Mobilisation Chemotherapy: Vinorelbine |
| GemcitabineAlso: Gemcitabine SandozMobilisation Chemotherapy | Drug | Mobilisation Chemotherapy: Gemcitabine |
Primary outcome
CD34+ (cluster of differentiation 34) peripheral blood stem cells
Time frame: Day 8
Number of patients with collection of > 6 million CD34+ peripheral blood stem cells/kg body weight at day 8 after vinorelbine versus gemcitabine chemotherapy
6 secondary outcomes
Rate of peripheral neuropathy
Time frame: Between 15 and 30 days
Severity of peripheral neuropathy
Time frame: Between 15 and 30 days
Hematologic recovery
Time frame: Between 15 and 30 days
Minimal residual disease in the peripheral blood
Time frame: Day 8
Need to use the stem cell releasing compound Plerixafor
Time frame: Day 8
Response Rate
Time frame: Between 15 and 30 days
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 3 Apr 2018.
- Background: PubMed 8649495Attal M, Harousseau JL, Stoppa AM, Sotto JJ, Fuzibet JG, Rossi JF, Casassus P, Maisonneuve H, Facon T, Ifrah N, Payen C, Bataille R. A prospective, randomized trial of autologous bone marrow transplantation and chemotherapy in multiple myeloma. Intergroupe Francais du Myelome. N Engl J Med. 1996 Jul 11;335(2):91-7. doi: 10.1056/NEJM199607113350204.
- Individual participant dataSharing planned: No
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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.
Thomas Pabst, MD study chair
Inselspital , University Hospital Berne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vinorelbine and Gemcitabine in people with Multiple Myeloma and Amyloidosis, 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 8 inclusion and 4 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 3 Apr 2018. 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?
CD34+ (cluster of differentiation 34) peripheral blood stem cells (time frame: Day 8). 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 NCT02791373, 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 3 Apr 2018.