Clinical trial on induction of remission with bortezomib (Vel), cyclophosphamide (C) and dexamethasone (D) in patients until the age of 60 with untreated multiple myeloma and planned high dosage chemotherapy: (VelCD), (DSMM XIa)
- Conditions
- ntreated 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: 8.1Level: LLTClassification code 10028228Term: Multiple myeloma
- Registration Number
- EUCTR2005-003902-27-DE
- Lead Sponsor
- ORTHO BIOTECH, Division of JANSSEN-CILAG GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
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 < 10 g/dl)
- Osseous changes (lytic lesions or osteoporosis with compression
fractures)
3. Study part 1: Patients without cytostatic pretreatment designed for an induction
therapy with cyclophosphamide and dexamethasone (a radiotherapeutic pre-
treatment is allowed as well as a pretreatment with dexamethasone in patients
with renal insufficiency)
Study part II: Patients without cytostatic pretreatment designed for an induction
therapy with cyclophosphamide and dexamethasone (a radiotherapeutic pre-
treatment is allowed as well as a pretreatment with dexamethasone)
4. Existence of patient’s written informed consent
5. Women must be postmenopausal or sterilized; patients of childbearing potential
must use a safe method of contraception during treatment and for 6 months after
completion and have a negative pregnancy test at the time of screening
6. Male patients must use a reliable method of contraception during treatment and
up to 6 months after completion.
7. Karnofsky status 60% or more
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 haematological functions:
- Leukocytes more than 3.0 x 109/l
- Neutrophils more than 1.5 x 109/l
- Platelets more than 75 x 109/l
11. Creatinine clearance > 30 ml/min
12. Adjusted serum calcium < 14 mg/dl (3.5 mmol/l)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method