A Randomized Controlled Study of DOXIL/CAELYX (doxorubicin HCL liposome injection) and VELCADE (bortezomib) or VELCADE Monotherapy for the Treatment of Relapsed Multiple Myeloma - doxil/caelyx plus velcade versus velcade alone in relapse multiple myeloma
- Conditions
- Recurred or relapsed multiple myeloma
- Registration Number
- EUCTR2004-001842-34-ES
- Lead Sponsor
- Johnson&Johnson Pharmaceutical Research and Development, Division de Janssen-Cilag
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 646
- Male or female and at least 18 years-of-age
- Histologically confirmed diagnosis of multiple myeloma with evaluable disease parameters
- Progressive Disease after an initial response (complete, partial, or minimal) to at least 1 line of therapy, which includes at a minimum an alkylating agent or anthracycline and corticosteroids
A single line of therapy may consist of one or more cytotoxic drugs such as melphalan plus prednisone; vincristine plus doxorubicin (or DOXIL/CAELYX) plus dexamethasone; or high-dose pulse corticosteroid.
A single line of therapy may include hematopoietic stem cell transplantation plus maintenance treatment as well as induction with VAD or another regimen
or
Progressing during initial therapy that included, at a minimum, an alkylating agent and corticosteroids
- Progressive disease as defined by one of the following:
>25% increase in M-protein
Development of new or worsening lytic bone lesions, plasmacytoma or hypercalcemia (>11.5 mg/dL corrected) despite appropriate medical treatment
- Measurable secretory disease defined as either:
Quantifiable serum monoclonal antibody defined as a serum monoclonal protein >1 g/dL for immunoglobulin G (IgG), >0.5 g/dL for immunoglobulin A (IgA), or > 0.05 g/dL of immunoglobulin D (IgD)
Measurable urine levels of monoclonal protein (>200mg/24 hours)
- ECOG performance status of 0 or 1
- Life expectancy of at least 3 months
- At randomization hematologic values within the following limits
Absolute neutrophil count (ANC) > or =1,000/mm3
Platelet count > or =75,000/mm3 without transfusion support for 7 days prior to study
Hemoglobin > or =8.0 g/dL without transfusion support for 7 days prior to study entry
- At screening serum biochemical values within the following limits
Calculated (Cockroft-Gault formula) or measured creatinine clearance of > or =30 mL/minute, whichever is greater
Total bilirubin < or =1.5 x upper limit of normal (ULN)
Transaminases (AST/ALT) < or =2.5 x ULN
- At randomization a corrected serum calcium <12 mg/dL (3.0 mM/L). This level may be achieved by treatment but it must be reached before the subject may be randomized
- Left ventricular ejection fraction (LVEF) within institutional normal limits
- Recovered from the acute toxicity of any prior treatment
- Female subjects must be postmenopausal, surgically sterile, or practicing an effective method of birth control before entry and throughout the study
- Negative serum or urine beta-hCG pregnancy test at screening for subjects of child-bearing potential
- Able to respond to health outcomes questionnaire
- Subjects must have signed an informed consent document
- Subjects must have signed an informed consent for genetic testing. Participation in the genetic testing component is not mandatory for participation in the study.
- Subject is, in the investigator's opinion, able and willing to comply with the protocol requirements
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
- History of treatment with VELCADE
- Progressive disease while receiving an anthracycline containing regimen
- No change (NC) in disease status during initial therapy (Attachment 1: Response Criteria)
- Non-secretory disease (i.e., no measurable paraprotein in serum or urine; urine paraprotein level < or = 200 mg/24 hours).
- Prior treatment with doxorubicin, or equivalent, at cumulative doses in excess of 240 mg/m2 (i.e., 1 mg doxorubicin = 1 mg DOXIL/CAELYX = 1.8 mg epirubicin = 0.3 mg mitoxantrone = 0.25 mg idarubicin)
- Peripheral neuropathy of Grade 2 or greater severity as defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
- Myocardial infarct within 6 months before enrollment, New York Heart Association (NYHA) Class II or greater heart failure (Attachment 7), uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities
- Treatment with nitrosoureas within 6 weeks
- Treatment with chemotherapy (other than nitrosoureas), clarithromycin, or radiation therapy within 21 days before randomization
- Treatment with immuno- or antibody therapy within 60 days before randomization
- Treatment with plasmapheresis within 30 days before enrollment
- Major surgery within 30 days before Day 1 Cycle 1 except for minimally invasive procedures such as kyphoplasty
- Palliative radiation or surgery within 30 days prior to screening
- Allergic reactions to compounds containing boron, mannitol or doxorubicin, or other components of DOXIL/CAELYX or VELCADE
- Treatment for a malignant condition, other than multiple myeloma, within the 5 years prior to enrollment; except for basal cell carcinoma of the skin, non-metastatic squamous cell carcinoma of the skin, or cervical cancer in situ within the past 5 years
- Seropositive for HIV, or active hepatitis A, B, or C infection
- Poorly controlled hypertension, diabetes mellitus or other serious medical or psychiatric conditions that could interfere with adherence to or completion of this study
- Pregnant or breast-feeding
- Currently enrolled in another clinical research study or less than 30 days since receiving treatment on a research study (patients participating in studies unrelated to their cancer may be enrolled after consultation with and approval by the sponsor)
- Employee of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.
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