Multiple MyelomaPhase 2/3NCT00861250
Assessment of Molecular Remission by ASO-qPCR After Bortezomib-dexamethasone (Vel/Dex) Followed by ASCT
A Phase 2/3 study testing bortezomib + dexamethasone in people with Multiple Myeloma, run by Tampere University Hospital at 1 site in Finland.
Trial summary
The primary objective of this study is to determine the rate of molecular remissions (MolR) assessed by ASO-RQ-PCR technique after induction treatment with bortezomib and dexamethasone (Vel/Dex) prior to high-dose therapy with melphalan and autologous stem cell transplantation (HDT-ASCT), and after HDT-ASCT in… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- bortezomib + dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteFinland
- Study dates
- Mar 2009to Jul 2015
- Phase
- Phase 2/3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic multiple myeloma
- Age 18-65 years
- Written informed consent
Who cannot join
- WHO performance status ≥ 2, unless related to MM
- Severe cardiac dysfunction
- History of hypotension
- Serious medical or psychiatric illness
- Severe hepatic dysfunction
- Severe polyneuropathy ≥ grade 2
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- Active, uncontrolled infection
- Previously treated with chemotherapy or extensive radiotherapy for MM
- Known HIV positivity
- Severe renal dysfunction with need of dialyses
- History of active cancer during past 5 years, except non-melanoma skin cancer or stage 0 cervical cancer
- Female patients who are pregnant or nursing
- Male or female patients of reproductive potential who are not practising effective means of contraception
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Molecular Remission by ASO-RQ-PCR Technique After Induction Treatment With Bortezomib-dexamethasone (Vel/Dex) Followed by HDT With ASCT
The primary objective of this study is to determine the rate of molecular remissions (MolR) assessed by ASO-RQ-PCR technique after induction treatment with bortezomib and dexamethasone (Vel/Dex) prior to high-dose therapy with melphalan and autologous stem cell transplantation (HDT-ASCT), and after HDT-ASCT in patients with multiple myeloma.
Read the detailed description
HDT-ASCT is so far considered the standard of care for younger patients with multiple myeloma (MM). Current evidence indicates that quality of response is an important prognostic factor for long-term survival in MM. There are only very few data on molecular remissions (MolR) determined by the most sensitive technique, allele-specific-oligonucleotide - real-time quantitative - polymerase chain reaction (ASO-RQ-PCR) in MM, and there are no data available on molecular responses after bortezomib-based induction therapy followed by HDT-ASCT. The main aim of this study is to determine molecular response rate after ASCT following bortezomib-based induction treatment compared to a historical control group with conventional VAD induction treatment. A sensitivity of ASO-RQ-PCR technique will be compared to immunofixation and with immunophenotyping by flow cytometry.
- Conditions
- Multiple Myeloma
- Being tested
- bortezomib + dexamethasone
- Keywords
- Bortezomib plus dexamethasone induction therapy, Autologous stem cell transplantation, Molecular remission
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bortezomib + dexamethasoneDrug
Also called VelcadeTM
Bortezomib 1,3mg/m2 iv days 1,4,8,11, dexamethasone 40mg/day days 1-4, 9-12 in cycles 1- 2, then bortezomib 1,3mg/m2 iv days 1,4,8,11, dexamethasone 40mg/day days 1-4 in cycles 3-4, total number of cycles is 4, followed by HDT with ASCT
| Study group | Role | What they receive |
|---|---|---|
| Vel/Dex | Experimental | Not described Receives: Drug: bortezomib + dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular remission after Vel/Dex induction (4 cycles) and 3-4 months after ASCT in those patients receiving CR or nCR
Measured: Before ASCT and 3-4 months after ASCT and then with 3-4 months interval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionDec 2014
- Study completionJul 2015
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.
- More trials run by Tampere University HospitalThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Turku University Hospital, Oulu University Hospital, Kuopio University Hospital, Helsinki University Central Hospital, Kanta-Häme Central Hospital, Seinajoki Central Hospital, Jyväskylä Central Hospital, Janssen-Cilag Ltd., Päijänne Tavastia Central Hospital
- Responsible party
- Sponsor
- Investigators
- Raija H Silvennoinen, MD, Principal investigator, Tampere University Hospital, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00861250
- Sponsor's protocol ID
- R08096M
- Other IDs
- 2008-003936-38, 26866138MMY2063, 2008
- Status last verified
- Dec 2014
- First submitted
- 12 Mar 2009
- Last updated
- 17 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Molecular Remission by ASO-RQ-PCR Technique After Induction Treatment With Bortezomib-dexamethasone (Vel/Dex) Followed by HDT With ASCT
- ClinicalTrials.gov ID
- NCT00861250
- Acronym / sponsor ID
- R08096M
- Conditions
- Multiple Myeloma
- Keywords
- Bortezomib plus dexamethasone induction therapy, Autologous stem cell transplantation, Molecular remission
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Turku University Hospital, Oulu University Hospital, Kuopio University Hospital, Helsinki University Central Hospital, Kanta-Häme Central Hospital, Seinajoki Central Hospital, Jyväskylä Central Hospital, Janssen-Cilag Ltd., Päijänne Tavastia Central Hospital
- Study start
- Mar 2009
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 13 Mar 2009 (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 primary objective of this study is to determine the rate of molecular remissions (MolR) assessed by ASO-RQ-PCR technique after induction treatment with bortezomib and dexamethasone (Vel/Dex) prior to high-dose therapy with melphalan and autologous stem cell transplantation (HDT-ASCT), and after HDT-ASCT in patients with multiple myeloma.
Detailed description
HDT-ASCT is so far considered the standard of care for younger patients with multiple myeloma (MM). Current evidence indicates that quality of response is an important prognostic factor for long-term survival in MM. There are only very few data on molecular remissions (MolR) determined by the most sensitive technique, allele-specific-oligonucleotide - real-time quantitative - polymerase chain reaction (ASO-RQ-PCR) in MM, and there are no data available on molecular responses after bortezomib-based induction therapy followed by HDT-ASCT. The main aim of this study is to determine molecular response rate after ASCT following bortezomib-based induction treatment compared to a historical control group with conventional VAD induction treatment. A sensitivity of ASO-RQ-PCR technique will be compared to immunofixation and with immunophenotyping by flow cytometry.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vel/Dex | Experimental | Drug: bortezomib + dexamethasone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Symptomatic multiple myeloma
- Age 18-65 years
- Written informed consent
Key exclusion criteria (13 listed)
- WHO performance status ≥ 2, unless related to MM
- Severe cardiac dysfunction
- History of hypotension
- Serious medical or psychiatric illness
- Severe hepatic dysfunction
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 |
|---|---|---|
| bortezomib + dexamethasoneAlso: VelcadeTMBortezomib 1,3mg/m2 iv days 1,4,8,11, dexamethasone 40mg/day days 1-4, 9-12 in cycles 1- 2, then bortezomib 1,3mg/m2 iv days 1,4,8,11, dexamethasone 40mg/day days 1-4 in cycles 3-4, total number of cycles is 4, followed by HDT with ASCT | Drug | Vel/Dex |
Primary outcome
Molecular remission after Vel/Dex induction (4 cycles) and 3-4 months after ASCT in those patients receiving CR or nCR
Time frame: Before ASCT and 3-4 months after ASCT and then with 3-4 months interval
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 17 Jun 2016.
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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 H Silvennoinen, MD principal investigator
Tampere University Hospital, Kuopio University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing bortezomib + dexamethasone in people with Multiple Myeloma, run by Tampere University Hospital at 1 site 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 3 inclusion and 13 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 17 Jun 2016. 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 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Molecular remission after Vel/Dex induction (4 cycles) and 3-4 months after ASCT in those patients receiving CR or nCR (time frame: Before ASCT and 3-4 months after ASCT and then with 3-4 months interval). 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 17 Jun 2016.