Bortezomib as consolidation therapy in patients aged 61-75 years with multiple myeloma

• Conditions: multiple myeloma in patients aged 61-75 years having been treated before initiation of the study with a high dosage chemotherapy with melphalane followed by an autologous stemcell transplantation; MedDRA version: 15.0Level: PTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2005-004947-73-DE
• Lead Sponsor: JANSSEN-CILAG GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-02
• Last Update Posted: 2 February 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 190

Inclusion Criteria

1. Patients aged between 61 and 75 years
2. Pretreatment with single- or tandem-HD-CT and autologous stemcell trans-
plantation in first line therapy (end of therapy at least 60 and maximum 120
days back)
3. No disease progression after HD-CT
4. Existence of patient’s written informed consent
5. Women must be either post-menopausal for 2 years minimum, hysterectomized,
or have had a tubal ligation; patients of childbearing potential must:
a) use a safe method of contraception during treatment and for 6 months after
completion
b) have a negative pregnancy test at time of screening
6. Male patients must use a reliable method of contraception during treatment and
up to 3 months after completion of treatment
7. Karnofsky status of 70% 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. Creatinine clearance > 30 ml/min
11. Adjusted serum calcium < 14 mg/dl (3.5 mmol/l)
12. Adequate haematological functions:
- leucocytes 3.0 x 109/l or more
- neutrophils 1.5 x 109/l or more
- platelets 75 x 109/l or more
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

Exclusion Criteria

1. Nonsecretory multiple myeloma
2. Previous allogenic stemcell transplantation
3. Known allergic reaction to bortezomib, boron or mannitol
4. Life expectancy of less than 3 months
5. Malignant neoplasia (except basalioma) within the past 5 years
6. Peripheral neuropathy of NCI-CTCAE grade 2 or more
7. Epilepsia
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
conditions
b) Cardiac failure > NYHA II; myocardial infarction within 6 months prior to
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
metabolic conditions
9. Hypotension (RRsys seated = 100 mmHg and/or RRdia seated = 60 mmHg)
10. HIV
11. Active hepatitis B and/or hepatitis C
12. Acute diffuse infiltrative pulmonary disease and pericardial disease
13. Unwillingness or unability to cooperate; foreseeable problems with follow-up;
psychiatric diseases; known current alcohol, drug, or substance abuse; legal
incapacity
15. Concurrent involvement in another clinical trial, 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
Main Objective: - progression free survival (PFS) with and without bortezomib consolidation therapy;Secondary Objective: - response rate<br>- overall survival<br>- time to progression<br>- event free survival (EFS)<br>- portion of patients with a skeletal related event (SRE)<br>- time interval from the day of transplantation until the occurrence of the first SRE<br>- duration of response<br>- toxicities in the course of the consolidation therapy<br>- comparison of quality of life with/without consolidation therapy by means of a <br> validated questionnaire<br>- comparison of response rates in the treatment arm in dependance of cytogenetic <br> changes;Primary end point(s): dose-limiting toxicity<br>