Cytologically and/or histologically established multiple myeloma requiring treatment, stage II or III (Salmon and Durie). 1. - 3. Relapse or progression with measurable myeloma protein in the blood or urine following chemotherapy or high-dose therapy with autologous stem cell transplantation
Conditions
Interventions
Trade Name: Velcade 3,5 mg Pulver zur Herstellung einer Injektionslösung
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Bortezomib
CAS Number: 179324-69-7
Othe
Sponsors
ORTHO BIOTECH, Division of JANSSEN-CILAG GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female myeloma patients aged between 18 and 80 years 2. Cytologically and/or histologically established multiple myeloma requiring treat- ment, ISS stage II or III. 3. 1.-3. Relapse or progression with measurable myeloma protein in the blood or urine following chemotherapy or high-dose therapy with autologous stem cell transplantation 4. Patient’s written informed consent has been obtained 5. Women must be either post-menopausal or previously sterilised; patients of childbearing potential must: a) use a safe method of contraception during treatment and for 6 months after com- pletion (oral combination contraceptives, depot injections, implantates, IUDs (hormonal IUD acting as a combination of mechanical and hormonal contra- ceptive), sexual abstinence, vasectomized partner) b) have a negative pregnancy test at time of screening6. Male patients must use a reliable method of contraception during treatment and up to 6 months after com- pletion.(Men who are planning to have children should be offered the option of sperm cryopreservation.) 7. Karnofsky status >= 60% 8. AST (S-GOT) or ALT (S-GPT) less than 2.5 times the upper limit of normal 9. Total bilirubin less than 1.5 times the upper limit of normal 10. Adequate hematological functions: leukocytes >= 3.0 x 109/l neutrophils >= 1.5 x 109/l platelets >= 75 x 109/l 11. Creatinine clearance > 30 ml/min 12. Adjusted serum calcium =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Nonsecretory multiple myeloma 2. Previous treatment with bendamustine and/or bortezomib within the past 6 months 3. Previous allogeneic transplantation 4. Known allergic reaction to bortezomib, bendamustine, boron, or mannitol 5. Life expectancy of less than 3 months 6. Malignant neoplasia (except basalioma) within the past 5 years 7. Peripheral neuropathy of NCI-CTC grade >= 2 8. Other severe comorbidities which, in the attending physician’s opinion, preclude involvement in the trial: a) hepatic or renal insufficiency; clinically relevant pulmonary or gastrointestinal con- ditions b) cardiac failure > NYHA II; myocardial infarction within 6 months prior to screening; Screening; pectoral angina; cardiac arrhythmia (> Lown IVb); ECG evidence of acute ischaemia; Conduction disorders; cardiac amyloidosis c) Systemic infection requiring treatment d) Poorly controlled hypertension or other clinically relevant vascular conditions e) Poorly controlled Diabetes mellitus or other clinically relevant endocrine or meta- bolic conditions 9. Epilepsia 10. Hypotension (RRsys seated <= 100 mmHg and/or RRdia seated <= 60 mmHg) 11. HIV-positive patients 12. Active hepatitis B and/or hepatitis C 13. Pregnant or breastfeeding patients 14. Unwillingness or unability to cooperate; foreseeable problems with follow-up; psychiatric disorders; known current alcohol, drug, or substance abuse; legal in- capacity 15. Concurrent involvement in other clinical trials, or involvement in another clinical trial within 30 days prior to inclusion in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - Finding out the maximum tolerable dose of bendamustin in combination with a fixed dose of bortezomib and prednisolone - Safety and tolerability of the combination therapy;Secondary Objective: - Overall response rate (EBMT criteria) - Progression free survival - Overall survival;Primary end point(s): Occurrence of dose-limiting toxicity (DLT). | — |
Countries
Germany
Outcome results
None listed