Multiple MyelomaPhase 2NCT00311337
VELCADE as Maintenance Treatment in Patients With Multiple Myeloma Following Autologous Peripheral Blood Stem Cell Transplantation (PBSCT)
A Phase 2 study testing bortezomib in people with Multiple Myeloma, run by University of Wuerzburg at 8 sites in 3 countries.
Trial summary
Protocol DSMM VIII is a multi-center, open-label study evaluating the safety and tolerability, as well as the efficacy, of maintenance treatment with VELCADE (bortezomib) in patients with multiple myeloma with detectable disease activity following tandem high-dose chemotherapy and autologous SCT. 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?
- bortezomib
- How many people
- 61 participants
- Where
- 8 sitesin 3 countries
- Study dates
- Oct 2005to Oct 2010
- 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
- Patient having received tandem transplants with high-dose melphalan and autologous PBSCT within 3-6 months prior to inclusion into this protocol
- Patients with measurable minimal residual disease (very good partial remission [VGPR]) or patients in partial remission (PR) or patients with stable disease (SD) at the time of inclusion in the study
- Patient must agree to participate in the study.
- Patient agrees to use an appropriate method of contraception.
- Willingness and ability to comply with the study protocol for the duration of the study
Who cannot join
- Patient showing signs of disease progression
- Patient has a platelet count < 100 x 10^9/L within 14 days before enrollment.
- Patient has an absolute neutrophil count < 1.0 x 10^9/L within 14 days before enrollment.
- Patient has a calculated or measured creatinine clearance < 30 mL/minute within 14 days before enrollment.
- Patient has >= Grade 2 peripheral neuropathy within 14 days before enrollment.
- Patient has hypersensitivity to bortezomib, boron, or mannitol.
Show all 14Show fewer
- Patient has received prior treatment with bortezomib
- Patient is pregnant or nursing
- Patient has received other investigational drugs within 14 days before enrollment
- Patient has progressive disease
- Patient has a Karnofsky performance status < 60%
- Patient has a life expectancy of < 3 months
- Patient has received disease modifying agents following autologous stem cell transplantation other than aminobisphosphonates such as interferon-alpha or glucocorticosteroids
- Patient currently enrolled in another clinical research study and/or receiving an investigational reagent for any reason.
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
Germany5 sites, 5 recruiting
- Recruiting
Dept. of Hematology/Oncology, Charité Berlin
Berlin, 10098
Orhan Sezer, MD, 030/450-513105, sezer@charite.de
Orhan Sezer, MD
- Recruiting
Dept. of Internal Medicine, Ludwig-Maximilian-University Munich
Munich, 80336
Christian Straka, MD, 089/5160-2278, cstraka@medinn.med.uni-muenchen.de
Christian Straka, MD
- Recruiting
Dept. of Internal Medicine A, University Muenster
Münster, 48129
Martin Kropff, MD, kropff@uni-muenster.de
Martin Kropff, MD
- Recruiting
Dept. of Internal Medicine III, University of Ulm
Ulm, 89081
Peter Liebisch, MD, 0731/500-33809, peter.liebisch@medizin.uni-ulm.de
Peter Liebisch, MD
- Recruiting
Dept. of Internal Medicine II, University of Wuerzburg
Würzburg, 97070
Hermann Einsele, MD, +4993120170011, einsele_h@klinik.uni-wuerzburg.de
Volker Kunzmann, MD
Austria2 sites, 2 recruiting
- Recruiting
Medizinische Univ.-Klinik Graz
Graz, 8036
Werner Linkesch, MD, ++43(0)316/385-4086, werner.linkesch@kfunigraz.ac
Werner Linkesch, MD
- Recruiting
Klin. Abt. für Onkologie, AKH Wien
Vienna, 1090
Johannes Drach, MD, heinz.gisslinger@akh-wien.ac.at
Johannes Drach, MD
Italy1 site, 1 recruiting
- Recruiting
Regionalkrankenhaus Bozen
Bolzano, 39100
Paolo Coser, MD, 0039/471/908807, emat@asbz.it
Paolo Coser, MD
About this study
Official title: Evaluation of Safety and Efficacy of VELCADE as Maintenance Treatment in Patients With Multiple Myeloma Following High-Dose Melphalan Treatment and Autologous PBSCT (Minimal Residual Disease, Partial Remission or Stable Disease)
Protocol DSMM VIII is a multi-center, open-label study evaluating the safety and tolerability, as well as the efficacy, of maintenance treatment with VELCADE (bortezomib) in patients with multiple myeloma with detectable disease activity following tandem high-dose chemotherapy and autologous SCT. The time from SCT to the initiation of VELCADE treatment will be 3 to 6 months.
Read the detailed description
Protocol DSMM VIII is a multi-center, open-label study evaluating the safety and tolerability, as well as the efficacy, of maintenance treatment with VELCADE in patients with multiple myeloma with detectable disease activity following tandem high-dose chemotherapy and autologous SCT. The time from SCT to the initiation of VELCADE treatment will be 3 to 6 months.
The initial 11 patients entered into this trial will be treated at a dose level of 1.0 mg/m2 once weekly on 4 consecutive weeks followed by 2 weeks of rest. A total of 4 treatment cycles is planned.
An interim analysis for safety and tolerability will be performed after at least the first cycle of study drug has been completed. If the study treatment is found to be safe and no dose-limiting toxicity has occurred, the dose of VELCADE will be increased to 1.3 mg/m2 and another 11 patients will be treated at this dose level according to the treatment schedule as outlined above. The dose escalation to 1.3 mg/m2 will be performed without delay if no AE or SAE are reported to the principal investigator.
If the safety of a specific dose level is acceptable the efficacy of the maintenance treatment will be statistically evaluated. The treatment is considered to be efficacious if a minimum of 25% of all treated patients experience a success, considered as remission of their disease within 6 months after the end of VELCADE treatment. The therapy will be acceptable for further clinical studies if a minium of 25% successfully treated patients will be observed.
Under these assumptions in the first step of the optimal two step design (Simon 1989) 21 patients have to be treated. As patients included during phase I are included in the efficacy analysis, this means an additional 10 patients to be treated. If less than three patients were successfully treated defined as an improvement in the remission status, the study will be stopped, because the success rate is unacceptably low. If three or more of the 21 patients are successfully treated, another 29 patients will be included. At the end of the study the success rate will be evaluated. If 8 or more of the 50 patients were successfully treated the therapy will be acceptable for further studies.
Patients will be evaluated at scheduled screening and baseline visits. After providing written informed consent to participate in the study, patients will be screened for study eligibility during a screening period of 28 days. Baseline assessment consists of a detailed history of pre-existing diseases, blood tests including disease-specific markers such as ß2-microglobulin, IgG, IgA, IgM, immunofixation from blood and urine, serum free light chains, a bone marrow biopsy, a skeletal survey, an electrocardiogram and a chest X-ray.
The study drug will be administered in study centers only. Prior to each administration of study drug, a short medical history focusing on VELCADE-associated side effects will be performed as well as complete blood cell counts, kidney and liver function tests.
A visit on day 30 following the last administration of study drug for the final assessment of safety and tolerability is mandatory in all patients included in this protocol.
Serological myeloma specific markers (monoclonal immunoglobulin, serum free light chains and immunofixation from blood and urine) will be performed at weeks 6, 12, 18 and 24 and thereafter in 3 months intervals. Bone marrow biopsies will be performed when serological markers indicate complete remission or progression, a skeletal survey once a year during follow-up. During the study, disease will be assessed according to the EBMT/IBMTR/ABMTR criteria.
Safety will be evaluated by the occurrence of clinical and laboratory toxicities and changes from baseline in physical examination findings, vital signs, and, if applicable, chest X-ray and electrocardiogram findings. All patients will receive an aminobisphosphonate at 4 weekly intervals. Other disease-modifying treatment such as alpha interferon or pulsed corticosteroids are strictly prohibited.
- Conditions
- Multiple Myeloma
- Being tested
- bortezomib
- Keywords
- VELCADE, bortezomib, maintenance treatment, multiple myeloma, primary disease
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bortezomibDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoints are to study the safety of four cycles of VELCADE in patients with multiple myeloma following high-dose chemotherapy and autologous PBSCT.
Secondary outcomes (4)
The secondary objectives of this study are to assess the efficacy of four cycles of VELCADE at two different dose levels as maintenance treatment in patients with multiple myeloma
and detectable residual disease following high-dose chemotherapy and autologous PBSCT
to assess the 2 year progression-free survival
and to assess the 2 year overall survival.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2006 (estimated)
- Study startOct 2005
- Study completionOct 2010
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants
Sponsor and investigators
- Lead sponsor
- University of Wuerzburg
- Sponsor type
- University, hospital or other
- Investigators
- Hermann Einsele, MD, Principal investigator, Dept. of Internal Medicine II, University of Wuerzburg, Klinikstr. 6-8, 97070 WuerzburgHermann Einsele, MD, Principal investigator, Dept. of Internal Medicine, University of Wuerzburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00311337
- Sponsor's protocol ID
- DSMM VIII
- Status last verified
- Mar 2006
- First submitted
- 3 Apr 2006
- Last updated
- 5 Apr 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Efficacy of VELCADE as Maintenance Treatment in Patients With Multiple Myeloma Following High-Dose Melphalan Treatment and Autologous PBSCT (Minimal Residual Disease, Partial Remission or Stable Disease)
- ClinicalTrials.gov ID
- NCT00311337
- Acronym / sponsor ID
- DSMM VIII
- Conditions
- Multiple Myeloma
- Keywords
- VELCADE, bortezomib, maintenance treatment, multiple myeloma, primary disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 61 participants
- Lead sponsor
- University of WuerzburgUniversity, hospital or other
- Study start
- Oct 2005
- Study completion
- Oct 2010
- First posted
- 5 Apr 2006 (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.
Protocol DSMM VIII is a multi-center, open-label study evaluating the safety and tolerability, as well as the efficacy, of maintenance treatment with VELCADE (bortezomib) in patients with multiple myeloma with detectable disease activity following tandem high-dose chemotherapy and autologous SCT. The time from SCT to the initiation of VELCADE treatment will be 3 to 6 months.
Detailed description
Protocol DSMM VIII is a multi-center, open-label study evaluating the safety and tolerability, as well as the efficacy, of maintenance treatment with VELCADE in patients with multiple myeloma with detectable disease activity following tandem high-dose chemotherapy and autologous SCT. The time from SCT to the initiation of VELCADE treatment will be 3 to 6 months.
The initial 11 patients entered into this trial will be treated at a dose level of 1.0 mg/m2 once weekly on 4 consecutive weeks followed by 2 weeks of rest. A total of 4 treatment cycles is planned.
An interim analysis for safety and tolerability will be performed after at least the first cycle of study drug has been completed. If the study treatment is found to be safe and no dose-limiting toxicity has occurred, the dose of VELCADE will be increased to 1.3 mg/m2 and another 11 patients will be treated at this dose level according to the treatment schedule as outlined above. The dose escalation to 1.3 mg/m2 will be performed without delay if no AE or SAE are reported to the principal investigator.
If the safety of a specific dose level is acceptable the efficacy of the maintenance treatment will be statistically evaluated. The treatment is considered to be efficacious if a minimum of 25% of all treated patients experience a success, considered as remission of their disease within 6 months after the end of VELCADE treatment. The therapy will be acceptable for further clinical studies if a minium of 25% successfully treated patients will be observed.
Under these assumptions in the first step of the optimal two step design (Simon 1989) 21 patients have to be treated. As patients included during phase I are included in the efficacy analysis, this means an additional 10 patients to be treated. If less than three patients were successfully treated defined as an improvement in the remission status, the study will be stopped, because the success rate is unacceptably low. If three or more of the 21 patients are successfully treated, another 29 patients will be included. At the end of the study the success rate will be evaluated. If 8 or more of the 50 patients were successfully treated the therapy will be acceptable for further studies.
Patients will be evaluated at scheduled screening and baseline visits. After providing written informed consent to participate in the study, patients will be screened for study eligibility during a screening period of 28 days. Baseline assessment consists of a detailed history of pre-existing diseases, blood tests including disease-specific markers such as ß2-microglobulin, IgG, IgA, IgM, immunofixation from blood and urine, serum free light chains, a bone marrow biopsy, a skeletal survey, an electrocardiogram and a chest X-ray.
The study drug will be administered in study centers only. Prior to each administration of study drug, a short medical history focusing on VELCADE-associated side effects will be performed as well as complete blood cell counts, kidney and liver function tests.
A visit on day 30 following the last administration of study drug for the final assessment of safety and tolerability is mandatory in all patients included in this protocol.
Serological myeloma specific markers (monoclonal immunoglobulin, serum free light chains and immunofixation from blood and urine) will be performed at weeks 6, 12, 18 and 24 and thereafter in 3 months intervals. Bone marrow biopsies will be performed when serological markers indicate complete remission or progression, a skeletal survey once a year during follow-up. During the study, disease will be assessed according to the EBMT/IBMTR/ABMTR criteria.
Safety will be evaluated by the occurrence of clinical and laboratory toxicities and changes from baseline in physical examination findings, vital signs, and, if applicable, chest X-ray and electrocardiogram findings. All patients will receive an aminobisphosphonate at 4 weekly intervals. Other disease-modifying treatment such as alpha interferon or pulsed corticosteroids are strictly prohibited.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient having received tandem transplants with high-dose melphalan and autologous PBSCT within 3-6 months prior to inclusion into this protocol
- Patients with measurable minimal residual disease (very good partial remission [VGPR]) or patients in partial remission (PR) or patients with stable disease (SD) at the time of inclusion in the study
- Patient must agree to participate in the study.
- Patient agrees to use an appropriate method of contraception.
- Willingness and ability to comply with the study protocol for the duration of the study
Key exclusion criteria (14 listed)
- Patient showing signs of disease progression
- Patient has a platelet count < 100 x 10^9/L within 14 days before enrollment.
- Patient has an absolute neutrophil count < 1.0 x 10^9/L within 14 days before enrollment.
- Patient has a calculated or measured creatinine clearance < 30 mL/minute within 14 days before enrollment.
- Patient has >= Grade 2 peripheral neuropathy within 14 days before enrollment.
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 | Drug | – |
Primary outcome
Primary endpoints are to study the safety of four cycles of VELCADE in patients with multiple myeloma following high-dose chemotherapy and autologous PBSCT.
4 secondary outcomes
The secondary objectives of this study are to assess the efficacy of four cycles of VELCADE at two different dose levels as maintenance treatment in patients with multiple myeloma
and detectable residual disease following high-dose chemotherapy and autologous PBSCT
to assess the 2 year progression-free survival
and to assess the 2 year overall survival.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2006.
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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.
Hermann Einsele, MD principal investigator
Dept. of Internal Medicine II, University of Wuerzburg, Klinikstr. 6-8, 97070 Wuerzburg
Hermann Einsele, MD principal investigator
Dept. of Internal Medicine, University of Wuerzburg
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bortezomib in people with Multiple Myeloma, run by University of Wuerzburg at 8 sites in 3 countries.
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 14 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: status not confirmed, as of the sponsor's last update on 5 Apr 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, Austria, Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hermann Einsele, MD (+49-931-20170011, einsele_h@klinik.uni-wuerzburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoints are to study the safety of four cycles of VELCADE in patients with multiple myeloma following high-dose chemotherapy and autologous PBSCT.. 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 5 Apr 2006.