Velcade (Bortezomib) Consolidation After Transplant
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Thalidomide; Bortezomib; Cyclophosphamide; Dexamethasone; Prednisolone
Intervention description: Thalidomide 100 mg tablet, orally.; Bortezomib 1.3 milligram per square meter (mg/m^2) solution for injection subcutaneously (SC).; Cyclophosphamide 300 mg/m^2 orally.; Dexamethasone 20 mg orally.; Prednisolone 50 mg orally.
Intervention MeSH terms: Thalidomide; Dexamethasone; Prednisolone; Cyclophosphamide; Bortezomib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 256.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Multiple Myeloma; Bortezomib; VELCADE; Consolidation therapy; Subcutaneous; Thalidomide; Prednisolone; Autologous stem cell transplant (ASCT); VELCADE, cyclophosphamide, dexamethasone (VCD) induction therapy

Summary:

      The purpose of this study is to determine if bortezomib when added to consolidation treatment
      with thalidomide and prednisolone leads to an improved response in patients with multiple
      myeloma who have undergone autologous stem cell transplant and initial treatment with
      bortezomib, cyclophosphamide, and dexamethasone.
    

Eligibility criteria:

        Inclusion criteria:

          -  Previously diagnosed with multiple myeloma based on international myeloma working
             group (IMWG) criteria.and meet all of the following; Serum M-protein greater than or
             equal to (>=) 1 gram per deciliter (g/dL) (>=10 gram per liter); Urine M-protein >=200
             milligram (mg) per 24 hour and Serum Free Light chain (FLC) assay: Involved FLC Level
             >=10 mg/dL (>=100 mg/L) provided serum FLC ratio is normal

          -  Meet the pretreatment laboratory criteria as specified in the study protocol at and
             within 21 days before baseline (Day 1 of Cycle 1, before bortezomib administration for
             induction).

          -  Have ECOG status 0-2.

          -  Men and women must practice an appropriate method of birth control as specified in the
             study protocol from signing of the informed consent form though to the 12-month
             visit/early termination visit.

        Exclusion criteria:

          -  Has previously received treatment for multiple myeloma (including prior therapy with
             radiation or pulsed dexamethasone) as specified in the study protocol.

          -  Has a history of any other malignancy within 5 years before enrolment as specified in
             the study protocol.

          -  Has had major surgery as specified in the study protocol within 30 days before
             enrolment.

          -  Had a myocardial infarction within 6 months of enrolment or has New York Heart
             Association (NYHA) Class III or IV heart failure (or other clinically significant
             cardiac medical history as specified in the study protocol).

          -  Has any condition that, in the opinion of the investigator, would make participation
             not be in the best interest (eg, compromise the well-being) of the patient or that
             could prevent, limit, or confound the protocol-specified assessments.