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An Open-label, Randomised Trial of Bortezomib Consolidation (With Thalidomide and Prednisolone) Vs Thalidomide and Prednisolone Alone in Previously Untreated Subjects With Multiple Myeloma After Receiving Bortezomib, Cyclophosphamide, Dexamethasone (VCD) Induction and Autologous Stem Cell Transplant


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

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Trial Information

An Open-label, Randomised Trial of Bortezomib Consolidation (With Thalidomide and Prednisolone) Vs Thalidomide and Prednisolone Alone in Previously Untreated Subjects With Multiple Myeloma After Receiving Bortezomib, Cyclophosphamide, Dexamethasone (VCD) Induction and Autologous Stem Cell Transplant


This is an open-label (patients will know the identity of study treatments), randomized
(patients will be assigned by chance to different treatments) study of bortezomib
administered as consolidation therapy (therapy given once a remission is achieved) with
thalidomide and prednisolone versus thalidomide and prednisolone alone in previously
untreated patients with multiple myeloma. Multiple myeloma is a cancer of your plasma cells,
a type of white blood cell present in your bone marrow. Patients in this study will receive
initial therapy with bortezomib, cyclophosphamide, and dexamethasone (referred to as VCD
induction therapy) and will undergo autologous stem cell transplant (ASCT) (a procedure
where patients receive an infusion of immature blood cells [stem cells] from their own body
to replenish the body's supply of healthy blood-forming cells) before randomization to one
of two treatments: Treatment A (thalidomide for up to 12 months or until disease progression
and prednisolone on alternate days continued indefinitely or until disease progression) or
Treatment B (bortezomib for 32 weeks in addition to thalidomide up to 12 months or until
disease progression and prednisolone on alternate days, continued indefinitely or until
disease progression.

Throughout the study, the patient's response to therapy will be assessed according to
protocol-defined efficacy evaluations and by implementing defined disease response criteria
(International Myeloma Working Group [IMWG] criteria). Safety will be evaluated throughout
the study. Follow up for progression-free survival (PFS) and overall survival (OS) will be
conducted from time of randomization to 3 years post-randomization.

Two interim analyses are planned. The final analysis will be conducted after all patients
have completed 12-month consolidation treatment phase or discontinued. The primary endpoint
of number and percent of patients with complete response and very good partial response
defined by IMWG criteria for multiple myeloma will be examined in the interim and final
analyses after approximately 12 months of consolidation therapy. At the completion of the
study, updated analyses of PFS and OS will be performed.

Inclusion Criteria


Inclusion criteria:

- Previously diagnosed with multiple myeloma based on international myeloma working
group (IMWG) criteria.

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The number and percent of patients with complete response (CR) + very good partial response (VGPR)

Outcome Time Frame:

After approximately 12 months of consolidation therapy

Safety Issue:

No

Principal Investigator

Janssen Asia-Pacific Medical Affairs Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen Asia-Pacific Medical Affairs

Authority:

Australia: National Health and Medical Research Council

Study ID:

CR018751

NCT ID:

NCT01539083

Start Date:

January 2012

Completion Date:

November 2017

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Bortezomib
  • VELCADE
  • Consolidation therapy
  • Subcutaneous
  • Thalidomide
  • Prednisolone
  • Autologous stem cell transplant (ASCT)
  • VELCADE, cyclophosphamide, dexamethasone (VCD) induction therapy
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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