Comparison of two strategies to treat refractory or relapsed Multiple Myeloma. All patients receive Bortezomib and Dexamethasone, one half receives additional Cyclophosphamide.
- Conditions
- Refractory or relapsed multiple myeloma after 1 to 3 previous lines of therapy, including high-dose therapyMedDRA version: 14.1Level: PTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2008-003213-27-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
- Not specified
1. Male or female =18 years of age
2. Informed consent
3. Diagnosis of multiple myeloma and measurable disease (serum M-protein
=1g/dL (10g/L, urine light-chain excretion =200mg/24h, involved FLC level
=10mg/dL provided sFLC ratio is abnormal)
4. Relapse or refraction of multiple myeloma following 1-3 previous lines of therapy and requires treatment. The subject has undergone or is not eligible for bone marrow transplantation.
5. Karnofsky status =60%
6. Life expectancy estimated at screening of at least 6 months
7. Willingness or ability to comply in the investigator's opinion
8. Women must be postmenopausal or surgically sterilized; women of childbearing
potential must use a safe method of contraception before entry and throughout
the study and have a negative pregnancy test at screening. Accepted is also a
male partner vasectomized
9. Male patients must use a reliable method of contraception from screening up to
6 months after trial completion.
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 21
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 89
1. More than three previous lines of therapy for multiple myeloma
2. Known allergy or hypersensitivity to bortezomib, dexamethasone and/or cyclo-
phosphamide or to any of the constituent compounds containing boron, mannitol,
or lactose
3. Progressive disease or stable disease under bortezomib in a previous line of
therapy
4. Oligosecretory or non-secretory multiple myeloma
5. Reception of nitrosoureas or any other chemotherapy within 6 weeks before
enrolment
6. Reception of corticosteroids (>10 mg/day prednisone or equivalent) within 3
weeks before enrolment
7. Immunotherapy or antibody therapy for multiple myeloma within 8 weeks
before enrolment (Ig substitution therapy is not excluded)
8. Plasmapheresis within 2 weeks before enrolment
9. Major surgery within 4 weeks before enrolment (kyphoplasty is not considered
major surgery)
10. Peripheral neuropathy or neuropathic pain of grade 2 or greater intensity, as
defined by NCI CTCAE, version 3.0
11. Uncontrolled or severe cardiovascular disease, including myocardial infarction
within 6 months before enrolment or NYHA Class III or IV heart failure, uncon-
trolled angina, acute diffuse infiltrative pulmonary and pericardial disease,
severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of
acute ischemia, active conduction system abnormalities or cardiac amyloidosis
12. Clinically relevant or poorly controlled vascular, pulmonary, gastrointestinal,
endocrine, neurological, psychiatric or metabolic diseases, which could potentially
interfere with the completion of treatment according to protocol
subject has urinary tract obstruction or cystitis before start of therepy
Subject has liver or renal insufficiency indicated by one or more of the following
pre-treatment laboratory values within 14 days before and at baseline:
· platelet count < 50×109/L (transfusion support within 14 days before the test
is not allowed)
· haemoglobin = 7,5 g/dL
· calculated or measured creatinine clearance < 20 mL/min
· absolute neutrophil count (ANC) < 0,75×109/L (the use of colony stimulating
factors within 14 days before the test is not allowed)
· adjusted serum calcium =14 mg/dL (3,5 mmol/L)
· aspartate transaminase (AST) > 2,5 × the upper limit of normal (ULN)
· alanine transaminase (ALT) > 2,5 × ULN
· total bilirubin > 1,5 × ULN
13. Malignancy other than multiple myeloma within 5 years before enrolment:
Exceptions for the following if treated and not active: basal cell or nonmetastatic
squamous cell carcinoma of the skin, cervical carcinoma in situ or FIGO Stage 1 of
the cervix
14. HIV positive status. When assessed by the investigator to be at risk for HIV
testing in accordance with local policies
15. Positive status of hepatitis B surface antigen or known active hepatitis C. When
assessed by the investigator to be at risk for hepatitis B or C testing in
accordance with local regulations
16. Systemic infection requiring treatment
17. Use of disallowed concomitant medication
18. Participation in other clinical studies conducted in parallel and participation in a
clinical study, i.e. subject has received an experimental drug or used an ex-
perimental medical device, within 30 days prior to enrolment in this study. This
does n
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