Bortezomib and Bendamustine in the Treatment of Refractory/Relapsed Multiple Myeloma
- Conditions
- 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
- Registration Number
- EUCTR2005-003843-30-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
- 44
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 < 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) yes
F.1.3.1 Number of subjects for this age range
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.
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