Untreated patients with cytologically and/or histologically established multiple myeloma (Durie and Salmon stage II or III) requiring treatment with measurable myeloma protein in the blood or urine. MedDRA version: 8.1 Level: LLT Classification code 10028228 Term: Multiple myeloma
Conditions
Interventions
Trade Name: VELCADE 3.5 mg Pulver zur Herstellung einer Injektionslösung
Product Code: PS-341, 26866138-AAA-PB-001
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Bortezomi
Sponsors
ORTHO BIOTECH, Division of JANSSEN-CILAG GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patients between 18 and 60 years of age 2. Multiple myeloma of stages II or III (Durie and Salmon). Patients requiring treat- ment are classified as follows: - Hypercalcaemia (serum calcium level > 0,25 mml/l above the upper limit of normal or > 2,5 mmol/l) - Renal impairment - Serum creatinine > 173 mm0l/l - Anaemia (haemoglobin 2g/dl below the laboratory specific normal value or 30 ml/min 12. Adjusted serum calcium =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Non-secretory multiple myeloma 2. Known allergic reaction to bortezomib, cyclophosphamide, boron, or mannitol 3. Life expectancy of less than 3 months 4. Malignant neoplasia (except basalioma) within the past 5 years 5. Peripheral neuropathy of CTC grade 2 or more 6. 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 diseases b) Cardiac failure > NYHA II; myocardial infarction within 6 months prior to screening; pectoral angina; cardiac arrhythmia (Lown IVb or more); ECG evidence of acute ischaemia; conduction disorders; cardiac amyloidosis c) Systemic infection requiring treatment d) Poorly controlled hypertension or other clinically relevant vascular diseases e) Poorly controlled diabetes mellitus or other clinically relevant endocrine or metabolic diseases 7. Hypotension (RRsys seated = 100 mmHg and/or RRdia seated = 60 mmHg) 8. HIV-positive status 9. Active hepatitis B and/or hepatitis C 10. Acute diffuse infiltrative pulmonary and pericardial disease 11. Pregnancy or breastfeeding period 12. Unwillingness or unability to cooperate; foreseeable problems with follow-up; psychiatric diseases; known current alcohol-, drug-, or substance abuse; legal incapacity 13. Current participation in another clinical trial or participation in a drug examination within the last 30 days before inclusion in this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Part I: - Evaluation if bortezomib can be combined with a standard dosage of cyclo- phosphamide and dexamethasone - Evaluation of the optimal dosage of cyclophosphamide Part II: - Efficiency of the induction therapy with bortezomib, cyclophosphamide and dexa- methasone (VelCD) - measured by the response rate (CR + PR combined) in comparison to historical data of the DSMM I- and DSMM V study ;Secondary Objective: 1. Safety of an induction therapy with bortezomib, cyclophosphamide and dexa- methasone (VelCD) 2. Comparison of the response rates depending on cytogenetic changes The cytogenetic risik profile will be recorded by the DSMM study group sub- sequent to the induction therapy and beyond this clinical trial in the frame of a prospective data collection. ;Primary end point(s): Primary: - Study part 1: Dosage of bortezomib in combination with cyclophosphamide with an incidence of dose limiting toxicity (DLT) below 33%. - Study part 2: Response rate (CR and PR combined) corresponding to EBMT-criteria. | — |
Countries
Germany
Outcome results
None listed