- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02237261
Bendamustine, Prednisone and Velcade® for First-line Treatment of Patients With Symptomatic Multiple Myeloma (BPV)
Bendamustine, Prednisone and Velcade® for First-line Treatment of Patients With Symptomatic Multiple Myeloma Not Eligible for High-dose Chemotherapy Followed by Autologous Stem Cell Transplantation (BPV).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Objectives Primary
-Therapeutic efficacy of BPV regimen for multiple myeloma as evidenced by the overall response defined as partial response (PR) or better
Secondary
- to assess overall survival (OS) and progression-free survival (PFS)
- to determine response duration
- to investigate improvements of renal function
- to evaluate safety and toxicity (with respect to adverse events of CTCAE grade ≧3 and SAEs)
- to analyze the efficacy for genetically defined subgroups of myeloma patients based on iFISH and gene-expression profiling
- Investigational Medicinal Products Bortezomib Bendamustine both in combination with Prednisone
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Aschaffenburg, Germany, 63739
- Klinikum Aschaffenburg, Med. Klinik II
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Oldenburg, Germany, 26121
- Onkologische Praxis Oldenburg/Delmenhorst
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BW
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Heidelberg, BW, Germany, 69115
- Onkologische Schwerpunktpraxis
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Heidelberg, BW, Germany, 69120
- Medizinische Klinik V, Universitätsklinikum Heidelberg, Sektion Multiples Myelom
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Ba-Wü
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Mannheim, Ba-Wü, Germany, 68161
- Mannheimer Onkologie Praxis
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Bayern
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Augsburg, Bayern, Germany, 86150
- Hämatologisch-onkologische Gemeinschaftspraxis
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Würzburg, Bayern, Germany, 97080
- Gemeinschaftspraxis Dr. R. Schlag/Dr. B. Schöttker
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Hessen
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Darmstadt, Hessen, Germany, 64295
- Onkologische Schwerpunktpraxis Dr. G. Kojouharoff
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Frankfurt, Hessen, Germany, 60389
- Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanienkrankenhaus
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Frankfurt, Hessen, Germany, 60431
- Agaplesion Markus Krankenhaus gGmbH, Medizinisches Versorgungszentrum
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NRW
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Hannover, NRW, Germany, 30171
- Onkologisches Ambulanzzentrum Hannover am Diakoniekrankenhaus Henriettenstift gGmbH
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Köln, NRW, Germany, 50677
- Onkologische Gemeinschaftspraxis
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RP
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Speyer, RP, Germany, 67346
- Onkologische Schwerpunktpraxis Speyer
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Rh-Pfalz
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Idar-Oberstein, Rh-Pfalz, Germany, 55743
- Klinikum Idar-Oberstein GmbH, Innere Medizin I
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Sachsen-Anhalt
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Dessau, Sachsen-Anhalt, Germany, 06847
- Städtische Klinikum Dessau
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Newly diagnosed multiple myeloma requiring systemic treatment (according to CRAB criteria as specified in the appendix I) with following characteristics: Subject is not a candidate for high-dose chemotherapy and stem cell transplantation due to age, presence of comorbidities likely to have a negative impact on tolerability of HDT-SCT, or subject preference
Measurable disease, defined as any quantifiable monoclonal protein value, defined by at least one of the following three measurements (Durie et al., 2006):
- Serum M-protein ≥ 10g/l
- Urine light-chain (M-protein) of ≥ 200 mg/24 hours
- Serum FLC assay: involved FLC level ≥ 10 mg/dl provided sFLC ratio is abnormal
- Age>18 years
- WHO performance status 0-3 (WHO=3 is allowed only when related to MM and not to co-morbid conditions) (see appendix III)
- For women of childbearing potential: negative pregnancy test at inclusion
- All patients must be willing and capable to use adequate contraception during the complete therapy.
- All patients must agree to abstain from donating blood while on study
- Ability to understand character and individual consequences of the clinical trial
- Written informed consent (must be available before enrolment in the trial)
Exclusion Criteria:
Subjects presenting any of the following criteria will not be included in the trial
- Patient has known hypersensitivity to bortezomib, bendamustine and prednisone or to any of the constituent compounds (incl. boron and mannitol).
- Systemic AL amyloidosis (except for patients with AL amyloidosis of the skin or the bone marrow)
- Chemotherapy or radiotherapy during the past 5 years except patients with local radiotherapy in case of local myeloma progression. (Note: patients may have received a cumulative dose of up to 160 mg of dexamethasone or equivalent as emergency therapy within 3 weeks prior to study entry.)
- Plasma cell leukemia which requires the presence of 20% of plasma cell in peripheral blood leukocytes and at least 2 plasma cells/nl.
- Severe cardiac dysfunction (NYHA classification III-IV, see appendix III)
- Significant hepatic dysfunction (serum bilirubin ≥ 2 mg/dl or ASAT and/or ALAT ≥ 2.5 times normal level), unless related to myeloma
- Patients known to be HIV-positive
- Patients with active, uncontrolled infections
- Patients with peripheral neuropathy or neuropathic pain of CTC grade 2 or higher (as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0, see appendix V)
- Second malignancy during the past 5 years except:
- Adequately treated basal cell or squamous cell skin cancer, or
- Carcinoma in situ of the cervix, or
- Prostate cancer < Gleason score 6 with undetectable prostate-specific antigen (PSA) over 12 months, or
- Ductal breast carcinoma in situ with full surgical resection (i.e., negative margins), or
- Similar malignant condition as a.- d. with an expected5-year disease free survival larger than 95% 11. Patients with acute diffuse infiltrative pulmonary and pericardial disease 12. Autoimmune hemolytic anemia with positive Coombs test or immune thrombocytopenia 13. Platelet count < 50 x 109/l (transfusion support within 14 days before the test is not allowed), unless related to myeloma 14. Hemoglobin < 7.5g/dl, unless related to myeloma 15. Absolute neutrophil count (ANC) < 0.75 x 109/l (the use of colony stimulating factors within 14 days before the test is not allowed), unless related to myeloma 16. Pregnancy and lactation 17. Participation in other clinical trials within one month prior to enrolment except for supportive care studies and vaccination studies. (Note: this does not include long-term follow-up periods without active drug treatment of previous studies during the last 6 months).
No subject will be allowed to enrol in this trial more than once.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Bendamustine, Bortezomib, Prednisone
Induction: Bortezomib: 1.3 mg/m2 subcutaneous for 7 days and Bendamustine: 90 mg/m2 intravenous for 2 days and in addition Prednison: : 60 mg/m2 per os for 4 days Consolidation: Bortezomib: 1.3 mg/m2 subcutaneous for 4 days and Bendamustine: 90 mg/m2 intravenous for 2 days and in addition Prednison 60 mg/m2 per os for 4 days
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Cycle 1 (d1-42) - Induction: Bortezomib: 1.3 mg/m2 s.c.: d1, 4, 8, 11, 22, 25, 29, 32 Bendamustine: 90 mg/m2 iv, d1, 2 Prednison: : 60 mg/m2 po,, d1-4 Cycle 2-9 (d1-28) - Consolidation: Bortezomib: 1.3 mg/m2 s.c.: d1, 8, 15, 22 Bendamustine: 90 mg/m2 iv: d1, 2 Prednison: 60 mg/m2 po: d1-4
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Response Rate (ORR) of BPV
Time Frame: 2 years
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ORR is defined as PR or better
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2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number and percentage of patients achieving a complete response
Time Frame: 2 years
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Number and percentage of patients achieving a complete response
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2 years
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Progression-free survival (PFS)
Time Frame: 2 years
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PFS defined as time from registration to progression or death whatever comes first
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2 years
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Overall survival (OS)
Time Frame: 2 years
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OS defined as time from registration to time of death from any cause.
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2 years
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Time-to-progression (TTP)
Time Frame: 2 years
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TTP defined as time from registration to disease progression.
TTP is censored at time of deaths which are not caused by progression.
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2 years
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Disease-free survival (DFS)
Time Frame: 2 years
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DFS defined as time from start of CR to relapse or death from any cause whichever comes first.
Patients evaluable for DFS are patients in complete Response.
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2 years
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Duration of response (DOR)
Time Frame: 2 years
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DOR defined as time from first observation of PR to the time of disease progression.
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2 years
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Renal response according to IMWG (CRrenal, PRrenal, MRrenal)
Time Frame: 2 years
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percent of patients with recovery/improvement of renal function (for patients with impared renal finction at baseline)
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2 years
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Toxicity (with respect to adverse events of CTCAE grade ≧3 and SAEs)
Time Frame: 2 years
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toxicity during study therapy with AE of CTC grade ≧ 3, as well as neuropathy of CTC grade 2, measured by CTC-AE (v4.0).
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2 years
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Time to objective Response (TOR)
Time Frame: 2 years
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TOR defined as time from registration to achieving an objective response for patients achieving an objective Response.
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2 years
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Time to treatment failure (TTF)
Time Frame: 2 years
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TTF is defined as time from registration to treatment discontinuation for any reason, including disease progression, Treatment toxicity, patient preference or death.
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2 years
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Wolfgang Knauf, MD, Hematology/Oncology,Bethanien hospital, Im Pruefling 17-19, 60389 Frankfurt/M., Germany
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Bendamustine Hydrochloride
- Prednisone
- Bortezomib
Other Study ID Numbers
- BPV
- 2013-005485-19 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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