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Randomized Phase III Trial of Consolidation Therapy With Bortezomib (Velcade®)- Lenalidomide (Revlimid®) -Dexamethasone (VRD) Versus Bortezomib (Velcade®) - Dexamethasone (VD) for Patients With Multiple Myeloma Who Have Completed a Dexamethasone Based Induction Regimen

Phase 3
18 Years
Open (Enrolling)
Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma

Thank you

Trial Information

Randomized Phase III Trial of Consolidation Therapy With Bortezomib (Velcade®)- Lenalidomide (Revlimid®) -Dexamethasone (VRD) Versus Bortezomib (Velcade®) - Dexamethasone (VD) for Patients With Multiple Myeloma Who Have Completed a Dexamethasone Based Induction Regimen


I. To compare the progression-free survival (PFS) of patients with previously treated
symptomatic multiple myeloma treated with consolidation therapy comprising bortezomib and
dexamethasone with vs without lenalidomide.


I. To determine the incremental ability of these regimens in attaining a complete response
or a very good partial response (VGPR) in these patients.

II. To compare the overall survival of patients treated with these regimens. III. To compare
the toxicity of these regimens in these patients. IV. To compare the quality of life of
these patients. V. To examine the impact of differential treatment response, if observed, on
quality of life of these patients.

VI. To obtain prospective data on multiple myeloma specific quality of life attributes.

OUTLINE: Patients are stratified according to prior induction therapy with lenalidomide and
dexamethasone (yes vs no) and whether or not they are in complete response after induction
therapy at study registration (yes vs no). Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive bortezomib IV on days 1, 4, 8, and 11, oral lenalidomide once a day
on days 1-14, and oral dexamethasone once a day on days 1-4. Treatment repeats every 21 days
for 8 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive bortezomib IV on days 1, 4, 8, and 11 and oral dexamethasone once a
day on days 1-4. Treatment repeats every 21 days for 8 courses in the absence of disease
progression or unacceptable toxicity.

Quality of life is assessed periodically. After completion of study treatment, patients are
followed every 3 months for 2 years, every 6 months for 3 years, and then every 12 months
for 5 years.

Inclusion Criteria:

- Diagnosis of symptomatic multiple myeloma

- Must meet the following criteria at one point in the course of the disease for the
original diagnosis of myeloma:

- Bone marrow plasmacytosis with > 10% plasma cells or sheets of plasma cells or
biopsy proven plasmacytoma

- Must have symptomatic disease that prompted the initiation of therapy (e.g.,
anemia, hypercalcemia, bone disease, or renal dysfunction)

- Must have completed a minimum of 1 and a maximum of 6 courses of a
dexamethasone-based regimen within the past 8 weeks, including any of the following:

- Dexamethasone alone

- Vincristine, doxorubicin, and dexamethasone

- Thalidomide and dexamethasone

- Lenalidomide and dexamethasone

- Liposomal doxorubicin and dexamethasone

- The combination of any of the above agents and dexamethasone

- Cyclophosphamide, lenalidomide, and dexamethasone

- Received a minimum cumulative dose of 160 mg of dexamethasone (no maximum dose

- Must have not experienced progressive disease on the dexamethasone-based regimen

- Patients diagnosed with only smoldering myeloma or monoclonal gammopathy of
undetermined significance are not eligible

- ECOG performance status 0-2

- Hemoglobin > 7 g/dL

- Platelet count > 75,000/mm^3

- Absolute neutrophil count > 1,000/mm^3 (without the use of growth factors to increase

- Creatinine < 2.5 mg/dL and creatinine clearance (measured or calculated) ≥ 60 mL/min

- Direct bilirubin < 1.5 mg/dL

- ALT and AST < 2.5 times upper limit of normal

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective double-method contraception for 4 weeks prior to,
during, and for 4 weeks after completion of study therapy

- No active uncontrolled seizure disorder

- No seizure within the past 6 months

- No concurrent uncontrolled illness that would limit compliance with the study,
including any of the following:

- Uncontrolled hypertension

- Symptomatic congestive heart failure

- Unstable angina

- Uncontrolled cardiac arrhythmia

- Uncontrolled psychiatric illness or social situation

- History of Steven Johnson syndrome

- No peripheral neuropathy ≥ grade 2

- No active uncontrolled infection

- Patients with a history of prior malignancy are eligible provided there is no active
malignancy AND there is a low expectation of recurrence within 6 months

- Must be willing and able to receive prophylaxis with aspirin (325 mg/day) or
alternative prophylaxis with low molecular weight heparin or coumadin

- Patients with prior DVT are eligible provided they remain on the anticoagulation
regimen that was prescribed for treatment of the DVT throughout study therapy

- Concurrent bisphosphonates or growth factors (e.g., granulocyte and/or erythropoietic
agents) for multiple myeloma allowed

- At least 14 days since prior palliative and/or localized radiotherapy

- Prior bortezomib allowed

Type of Study:


Study Design:

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

Outcome Measure:

PFS of two consolidation regimens

Outcome Description:

PFS in each of the arms will be estimated using the method of Kaplan and Meier. PFS between the two arms will be compared using one-sided stratified log-rank test.

Outcome Time Frame:

Time from consolidation randomization until progression or death of any cause, assessed up to 10 years

Safety Issue:


Principal Investigator

Rafael Fonseca

Investigator Role:

Principal Investigator

Investigator Affiliation:

Eastern Cooperative Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

August 2007

Completion Date:

Related Keywords:

  • Stage I Multiple Myeloma
  • Stage II Multiple Myeloma
  • Stage III Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



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