A Phase 2, Multicentre, Randomised, Open-Label, Parallel Group Study to Evaluate the Effect of VELCADE® on Myeloma related Bone Disease

Phase 1

• Conditions: Myeloma related bone disease; MedDRA version: 9.1Level: LLTClassification code 10028228Term: Multiple myeloma

• Registration Number: EUCTR2008-004264-39-CZ
• Lead Sponsor: Janssen-Cilag EMEA Medical Affairs

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-14
• Last Update Posted: 12 December 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Man or woman over 18 years of age
2. Response of PR or better after receiving high-dose chemotherapy followed by autologous stem cell transplantation (single- or double transplant) as primary therapy of the disease. Date of hospital discharge from stem cell transplantation has to be at least 60 days and within 120 days prior to randomization.
3. Karnofsky performance status of = 60
4. Life expectancy estimated at screening of at least 12 months
5. Following pre-treatment laboratory criteria at and within 14 days before baseline (Day 1 of Cycle 1, before study drug administration):
Platelet count = 50x 109/L without transfusion support within the 7 days before the test
Haemoglobin = 7.5 g/dL without transfusion support within the 7 days before the test
Absolute neutrophil count (ANC) = 0.75 x10 9/L without the use of colony stimulating factors
within 14 days before the test
Corrected serum calcium < 14 mg/dL (3.5 mmol/L)
Aspartate transaminase (AST): <= 2.5 x the upper limit of normal (ULN)
Alanine transaminase (ALT): <= 2.5 x ULN
Total bilirubin: <= 1.5 x ULN
6. Medically stable on the basis of physical examination, medical history, and vital signs, performed at screening. If there are abnormalities, they must be consistent with the underlying illness in the study population.

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

Exclusion criteria

1.Received another antimyeloma or experimental therapy following autologous stem cell transplantation
2.Known allergies, hypersensitivity, or intolerance to study drug or its excipients
3.[Exclusion criterion no. 3 is deleted]
4.Peripheral neuropathy or neuropathic pain of grade 2 or greater intensity, as defined by the National Cancer Institute Common Terminology Criteria of Adverse Events (NCI CTCAE), version 3.0
5.Myocardial infarction within 6 months of enrolment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
6.Poorly controlled hypertension, diabetes mellitus, or other serious medical condition (such as severe hepatic impairment, pericardial disease, acute diffuse infiltrative pulmonary disease, systemic infections, etc) or psychiatric illness likely to interfere with participation in this clinical study
7.Treated for a cancer other than multiple myeloma within 5 years before enrolment, with the exception of basal cell carcinoma or cervical cancer in situ
8.Known to be human immunodeficiency virus (HIV)-positive (Subjects assessed by the investigator to be at risk for HIV infection should be tested in accordance with local policies.)
9.Known to be hepatitis B surface antigen-positive or known active hepatitis C infection (Subjects assessed by the investigator to be at risk for hepatitis B or C infection are to be tested in accordance with local regulations.)
10.Active systemic infection requiring treatment

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified