VELCADE as Maintenance Treatment in Patients With Multiple Myeloma Following Autologous Peripheral Blood Stem Cell Transplantation (PBSCT)
NCT ID: NCT00311337
Last Updated: 2006-04-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
61 participants
INTERVENTIONAL
2005-10-31
2010-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
bortezomib
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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.
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Wuerzburg
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hermann Einsele, MD
Role: PRINCIPAL_INVESTIGATOR
Dept. of Internal Medicine II, University of Wuerzburg, Klinikstr. 6-8, 97070 Wuerzburg
Hermann Einsele, MD
Role: PRINCIPAL_INVESTIGATOR
Dept. of Internal Medicine, University of Wuerzburg
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medizinische Univ.-Klinik Graz
Graz, , Austria
Klin. Abt. für Onkologie, AKH Wien
Vienna, , Austria
Dept. of Hematology/Oncology, Charité Berlin
Berlin, , Germany
Dept. of Internal Medicine, Ludwig-Maximilian-University Munich
Munich, , Germany
Dept. of Internal Medicine A, University Muenster
Münster, , Germany
Dept. of Internal Medicine III, University of Ulm
Ulm, , Germany
Dept. of Internal Medicine II, University of Wuerzburg
Würzburg, , Germany
Regionalkrankenhaus Bozen
Bolzano, , Italy
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DSMM VIII
Identifier Type: -
Identifier Source: org_study_id