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Clinical Trials/CTRI/2011/05/001732
CTRI/2011/05/001732CompletedPhase 3

An Open-Label, Randomized Study of Subcutaneous and IntravenousVELCADE in Subjects With Previously Treated Multiple Myeloma - 26866138MMY3021

Johnson and Johnson Limited0 sites222 target enrollmentStarted: TBDLast updated:
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Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Enrollment
222
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Inclusion Criteria

  • •1. Male or female subjects 18 years or older
  • •Diagnosis of multiple myeloma based on the standard criteria described in Attachment 1.
  • •3. Measurable, secretory multiple myeloma defined as a serum monoclonal IgG of ≥10 g/L or a serum monoclonal IgA, IgD,or IgE
  • •≥5 g/L, or urine M-protein of ≥200 mg/24 hr
  • •4. Relapse or progression of myeloma following prior systemic antineoplastic therapy. Relapse or progression is defined by any of the following:
  • •? Reappearance of measurable disease (as defined above) following
  • •? ≥25% increase in serum or urine M-protein
  • •? Development of new or worsening lytic bone disease
  • •? New plasmacytomas or ≥50% increase in the longest dimension of
  • •an existing plasmacytoma
  • •? Worsening hypercalcemia (corrected serum Ca 11.5 mg/dL
  • •[2.8 mmol/L]) due to multiple myeloma
  • •5. Karnofsky performance status ≥70% (Attachment 2)
  • •6. Platelet count ≥50 x 109/L without transfusion support within 7 days
  • •before the laboratory test
  • •7. Hemoglobin ≥8 g/dL (≥4.96 mmol/L) without transfusion support
  • •within 7 days before the laboratory test.
  • •8. Absolute neutrophil count (ANC) ≥0.75 x 109/L.
  • •9. Corrected serum Ca 14 mg/dL (3.5 mmol/L)
  • •10. Aspartate aminotransferase (AST) ≤2.5X upper limit of normal (ULN)
  • •11. Alanine aminotransferase (ALT) ≤2.5X ULN
  • •12. Total bilirubin ≤1.5X ULN (except in subjects with congenital bilirubinemia, such as Gilbert syndrome)
  • •13. Creatinine clearance ≥20 mL/min, calculated using the formula
  • •14. Toxic effects of previous therapy or surgery have resolved to CTCAE Grade 1 or better
  • •15. Women who are not post-menopausal or surgically sterile must have a negative pregnancy test and agree to use an acceptable method of birth control during the study until 30 days after the last dose of study drug.
  • •16. Men must agree to not father a child and agree to use a latex condom during treatment and for 30 days after the last dose of study drug,
  • •even if they have had a successful vasectomy, if their partners are of childbearing potential.
  • •17. Voluntary written informed consent must be given before performance of any study related procedure not part of normal medical care, with the understanding that consent may be withdrawn
  • •by the subject at any time without prejudice to future medical care.

Exclusion Criteria

  • •1. Previous treatment with VELCADE
  • •2. More than 3 previous lines of therapy (separate lines of therapy are defined as single or combination therapies that are either separated by disease progression or by a 6 month treatment-free interval)
  • •3. Peripheral neuropathy or neuropathic pain of NCI CTCAE Grade ¡Ý2
  • •4. Any of the following within 3 weeks prior to randomization:antineoplastic or experimental therapy, corticosteroid use above10 mg/day (prednisone or equivalent), or plasmapheresis
  • •5. Any of the following within 2 weeks prior to randomization: radiation therapy, major surgery (kyphoplasty is not considered major surgery)
  • •6. Prior malignancy other than multiple myeloma diagnosed or treated within the last 2 years, with the exception of completely resected
  • •carcinoma in situ or basal/squamous carcinoma of the skin.
  • •7. Myocardial infarction within 6 months prior to enrollment or New
  • •York Heart Association (NYHA) Class III or IV heart failure,
  • •uncontrolled angina, severe uncontrolled ventricular arrhythmias, or
  • •electrocardiographic evidence of acute ischemia or clinically
  • •significant conduction system abnormalities
  • •8. Concurrent medical condition or disease (e.g., active systemic
  • •infection, uncontrolled diabetes, therapeutic use of anticoagulants)that is likely to interfere with study procedures or results (including local injection tolerability), that in the opinion of the investigator would constitute a hazard for participating in this study
  • •9. History of allergic reaction attributable to compounds containing boron or mannitol

Investigators

Sponsor
Johnson and Johnson Limited

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