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Bortezomib and Dexamethasone ...

Bortezomib and Dexamethasone With or Without Lenalidomide in Treating Patients With Multiple Myeloma Previously Treated With Dexamethasone

Last Updated: 2015-06-26

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2014-07-31

Brief Summary

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This randomized phase III trial compares bortezomib, dexamethasone, and lenalidomide with bortezomib and dexamethasone to see how well they work in treating patients with multiple myeloma previously treated with dexamethasone. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. It is not yet known whether giving bortezomib and dexamethasone is more effective with or without lenalidomide in treating multiple myeloma.

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Detailed Description

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PRIMARY OBJECTIVES:

I. To compare the progression-free survival (PFS) for two consolidation regimens: bortezomib, lenalidomide, and dexamethasone (VRD) versus bortezomib and dexamethasone (VD) only.

SECONDARY OBJECTIVES:

I. To determine the incremental ability of VRD versus VD in attaining a complete response or a very good partial response (VGPR) in patients receiving induction therapy with a dexamethasone based induction regimen.

II. To compare the overall survival, measured from the time of study entry.

III. Evaluate response rate and PFS according to cytogenetic category (by gene expression and fluorescence in situ hybridization \[FISH\]).

IV. To evaluate the toxicity of the two regimens.

V. To compare quality of life (QOL) based on the Functional Assessment of Cancer Therapy (FACT)-Neurotoxicity (Ntx) Trial Outcome Index (TOI) of patients receiving VD to those receiving VRD from registration to 6 months post consolidation treatment.

VI. To examine the impact of differential treatment response (PFS), if observed, on QOL based on the FACT-Ntx TOI up to 12 months post consolidation treatment.

VII. To obtain prospective data on multiple myeloma specific QOL attributes.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM A: Patients receive bortezomib at 1.3 mg/m2 intravenously (IV) on days 1, 4, 8, and 11, lenalidomide orally (PO) once daily (QD) at 15 mg on days 1-14, and dexamethasone at 40 mg total dose per day PO QD on days 1, 8, and 15. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive bortezomib at 1.3 mg/m2 IV on days 1, 4, 8, and 11 and dexamethasone at 40 mg total dose per day PO QD on days 1, 8, and 15. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.

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.

Conditions

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Stage I Multiple Myeloma Stage II Multiple Myeloma Stage III Multiple Myeloma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A (VRD)

Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib, dexamethasone and lenalidomide. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11; fixed dose of lenalidomide at 15 mg orally on days 1-14; and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15. Aspirin 325 mg/day orally on days 1-21 of each cycle was required unless the patient was treated with alternate prophylaxis of either low molecular weight heparin or coumadin.

Group Type EXPERIMENTAL

bortezomib

Intervention Type DRUG

Given IV

lenalidomide

Intervention Type DRUG

Given PO

dexamethasone

Intervention Type DRUG

Given PO

Arm B (VD)

Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib plus dexamethasone. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11 and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15.

Group Type ACTIVE_COMPARATOR

bortezomib

Intervention Type DRUG

Given IV

dexamethasone

Intervention Type DRUG

Given PO

Interventions

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bortezomib

Given IV

Intervention Type DRUG

lenalidomide

Given PO

Intervention Type DRUG

dexamethasone

Given PO

Intervention Type DRUG

Other Intervention Names

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PS-341 LDP-341 MLN-341 VELCADE CC-5013 CDC-501 Revlimid® (formerly Revimid®) Decadron Hexadrol Dexameth Dexone DXM

Eligibility Criteria

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Inclusion Criteria

* Symptomatic multiple myeloma, that was symptomatic at time of initial diagnosis, but may be asymptomatic at the time of registration based on induction therapy
* For the original diagnosis of myeloma, patients must have met the following criteria at one point in their disease course: bone marrow plasmacytosis (\>10% plasma cells or sheets of plasma cells) or a biopsy proven plasmacytoma, and evidence of end-organ damage due to multiple myeloma including anemia, hypercalcemia, bone disease (lytic bone lesions or pathologic fractures) or renal dysfunction.
* Patients may have prior exposure to bortezomib
* Patients must have received a minimum of 1 cycle, maximum of 6 cycles, of a dexamethasone-based regimen; patient must not have experienced progressive disease on such therapy
* The following induction regimens were considered adequate for enrollment: 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; or cyclophosphamide, lenalidomide and dexamethasone
* Patients must have received the minimum cumulative dose of dexamethasone of 160 mg (sum of induction treatment) with no maximum dose specified
* Patients must have been offered and refused front-line stem cell transplant OR not have been eligible for front-line stem cell transplant.
* Bone marrow aspiration and/or biopsy must be obtained =\< 28 days prior to randomization
* All tests below must be performed =\< 28 days prior to randomization:

* Kappa free light chain mg/dL
* Lambda free light chain mg/dL
* Serum M-protein by serum protein electrophoresis (SPEP)
* Urine M-protein light chain excretion by urine protein electrophoresis (UPEP)
* Adequate laboratory levels within 7 days prior to randomization: hemoglobin \> 7 g/dL, platelet count \> 75,000 cells/mm\^3, absolute neutrophil count \> 1000 cells/mm\^3, creatinine \< 2.5 mg/dL, creatinine clearance (measured or calculated) \>= 60 mL/min, direct bilirubin =\< 1.5 mg/dL, serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) and serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) =\< 2.5 times the upper limit of normal
* Patients may be receiving bisphosphonates or erythropoietin growth factors (erythropoietic agents) for multiple myeloma
* Prior palliative and/or localized radiation therapy is permitted, provided at least 14 days have passed from date of last radiation therapy to date of randomization
* Patients must be willing and able to take prophylaxis with either aspirin at 325 mg/day or alternative prophylaxis with either low molecular weight heparin or coumadin (patients with prior deep vein thrombosis \[DVT\] are eligible provided they remain on the anticoagulation regimen that was prescribed for treatment of the DVT throughout the protocol therapy)
* Patients must be competent to understand the study as explained in the consent form
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
* Sexually active males must be willing to use a condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking lenalidomide, and for 4 weeks after stopping treatment
* Patients with a history of prior malignancy are eligible provided there is no active malignancy and a low expectation of recurrence within 6 months
* Age \>=18 years

Exclusion Criteria

* More than 8 weeks from the last day of last cycle of induction treatment
* Active, uncontrolled seizure disorder; seizures in the last 6 months
* Uncontrolled inter-current illness that would limit compliance with the study including uncontrolled hypertension, symptomatic congestive heart failure, unstable angina, uncontrolled cardiac arrhythmia, uncontrolled psychiatric illness or social situation, prior history of Stevens Johnson syndrome
* Grade 2 or higher peripheral neuropathy by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
* Active, uncontrolled infection
* Smoldering myeloma or monoclonal gammopathy of undetermined significance
* Pregnant or nursing women were not eligible. Women of child-bearing potential unwilling to use a dual method of contraception and men who were unwilling to use a condom were not eligible

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rafael Fonseca, M.D.

Role: STUDY_CHAIR

Mayo Clinic

Locations

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Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Site Status

Northbay Cancer Center

Fairfield, California, United States

Site Status

Kaiser Permanente

San Diego, California, United States

Site Status

Stanford University Hospitals and Clinics

Stanford, California, United States

Site Status

The Medical Center of Aurora

Aurora, Colorado, United States

Site Status

Boulder Community Hospital

Boulder, Colorado, United States

Site Status

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

Site Status

Porter Adventist Hospital

Denver, Colorado, United States

Site Status

Exempla Saint Joseph Hospital

Denver, Colorado, United States

Site Status

Presbyterian - Saint Lukes Medical Center - Health One

Denver, Colorado, United States

Site Status

Rose Medical Center

Denver, Colorado, United States

Site Status

Colorado Cancer Research Program CCOP

Denver, Colorado, United States

Site Status

Swedish Medical Center

Englewood, Colorado, United States

Site Status

Saint Mary's Hospital and Regional Medical Center

Grand Junction, Colorado, United States

Site Status

North Colorado Medical Center

Greeley, Colorado, United States

Site Status

Saint Anthony Hospital

Lakewood, Colorado, United States

Site Status

Sky Ridge Medical Center

Lone Tree, Colorado, United States

Site Status

Longmont United Hospital

Longmont, Colorado, United States

Site Status

McKee Medical Center

Loveland, Colorado, United States

Site Status

Saint Mary Corwin Medical Center

Pueblo, Colorado, United States

Site Status

North Suburban Medical Center

Thornton, Colorado, United States

Site Status

Exempla Lutheran Medical Center

Wheat Ridge, Colorado, United States

Site Status

Beebe Medical Center

Lewes, Delaware, United States

Site Status

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

Site Status

Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status

John B Amos Cancer Center

Columbus, Georgia, United States

Site Status

Harbin Clinic Medical Oncology and Clinical Research

Rome, Georgia, United States

Site Status

Saint Anthony's Health

Alton, Illinois, United States

Site Status

Saint Joseph Medical Center

Bloomington, Illinois, United States

Site Status

Graham Hospital Association

Canton, Illinois, United States

Site Status

Memorial Hospital

Carthage, Illinois, United States

Site Status

Decatur Memorial Hospital

Decatur, Illinois, United States

Site Status

Alexian Brothers Medical and Cancer Center

Elk Grove Village, Illinois, United States

Site Status

Eureka Hospital

Eureka, Illinois, United States

Site Status

Saint Francis Hospital

Evanston, Illinois, United States

Site Status

Galesburg Cottage Hospital

Galesburg, Illinois, United States

Site Status

Illinois CancerCare Galesburg

Galesburg, Illinois, United States

Site Status

Western Illinois Cancer Treatment Center

Galesburg, Illinois, United States

Site Status

Mason District Hospital

Havana, Illinois, United States

Site Status

Hopedale Medical Complex - Hospital

Hopedale, Illinois, United States

Site Status

Joliet Oncology-Hematology Associates Limited

Joliet, Illinois, United States

Site Status

Mcdonough District Hospital

Macomb, Illinois, United States

Site Status

Garneau, Stewart C MD (UIA Investigator)

Moline, Illinois, United States

Site Status

Porubcin, Michael MD (UIA Investigator)

Moline, Illinois, United States

Site Status

Sharis, Christine M MD (UIA Investigator)

Moline, Illinois, United States

Site Status

Stoffel, Thomas J MD (UIA Investigator)

Moline, Illinois, United States

Site Status

Good Samaritan Regional Health Center

Mount Vernon, Illinois, United States

Site Status

Bromenn Regional Medical Center

Normal, Illinois, United States

Site Status

Community Cancer Center Foundation

Normal, Illinois, United States

Site Status

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, United States

Site Status

Ottawa Regional Hospital and Healthcare Center

Ottawa, Illinois, United States

Site Status

Pekin Cancer Treatment Center

Pekin, Illinois, United States

Site Status

Pekin Hospital

Pekin, Illinois, United States

Site Status

Methodist Medical Center of Illinois

Peoria, Illinois, United States

Site Status

Proctor Hospital

Peoria, Illinois, United States

Site Status

Illinois Oncology Research Association CCOP

Peoria, Illinois, United States

Site Status

OSF Saint Francis Medical Center

Peoria, Illinois, United States

Site Status

Illinois Valley Hospital

Peru, Illinois, United States

Site Status

Valley Radiation Oncology

Peru, Illinois, United States

Site Status

Perry Memorial Hospital

Princeton, Illinois, United States

Site Status

Saint Margaret's Hospital

Spring Valley, Illinois, United States

Site Status

Memorial Medical Center

Springfield, Illinois, United States

Site Status

Carle Clinic-Urbana Main

Urbana, Illinois, United States

Site Status

Saint Francis Hospital and Health Centers

Beech Grove, Indiana, United States

Site Status

Reid Hospital and Health Care Services

Richmond, Indiana, United States

Site Status

McFarland Clinic PC-William R Bliss Cancer Center

Ames, Iowa, United States

Site Status