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Bortezomib, Liposomal Doxorub...

Bortezomib, Liposomal Doxorubicin Hydrochloride, Dexamethasone, and Cyclophosphamide in Treating Patients With Multiple Myeloma That Relapsed After Autologous Stem Cell Transplant

Last Updated: 2015-01-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2014-03-31

Brief Summary

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This phase II trial is studying how well giving bortezomib together with liposomal doxorubicin hydrochloride, dexamethasone, and cyclophosphamide works in treating patients with multiple myeloma that relapsed after autologous stem cell transplant. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as liposomal doxorubicin hydrochloride, dexamethasone, and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with liposomal doxorubicin hydrochloride, dexamethasone, and cyclophosphamide may kill more cancer cells.

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Detailed Description

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PRIMARY OBJECTIVES:

I. To evaluate the 1-year survival of patients with relapsed multiple myeloma treated with bortezomib, liposomal doxorubicin, dexamethasone, and cyclophosphamide.

SECONDARY OBJECTIVES:

I. To evaluate response rates in patients treated with this regimen.

II. To evaluate the median time to progression in patients treated with this regimen.

III. To evaluate the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive bortezomib 1.3 mg/m2 subcutaneously on days 1, 8, and 15; liposomal doxorubicin 30 mg/m2 intravenously (IV) over 1 hour on day 4; oral dexamethasone 20mg on days 1, 2, 8, 9, 15 and 16; and cyclophosphamide 750 mg/m2 IV over 2 hours on day 1. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.

Peripheral blood and bone marrow samples may be collected for future research. Patients complete the Functional Assessment of Cancer Therapy (FACT) neurotoxicity questionnaire periodically.

After completion of study treatment, patients are followed up every 3 months for 3 years.

Conditions

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Refractory Multiple Myeloma

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment (combination chemotherapy)

Patients receive bortezomib 1.3 mg/m2 subcutaneously on days 1, 8, and 15; liposomal doxorubicin 30 mg/m2 intravenously (IV) over 1 hour on day 4; oral dexamethasone 20mg on days 1, 2, 8, 9, 15 and 16; and cyclophosphamide 750 mg/m2 IV over 2 hours on day 1. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.

Group Type EXPERIMENTAL

liposomal doxorubicin

Intervention Type DRUG

Given IV

bortezomib

Intervention Type DRUG

Given subcutaneously.

dexamethasone

Intervention Type DRUG

Given orally

cyclophosphamide

Intervention Type DRUG

Given IV

Interventions

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liposomal doxorubicin

Given IV

Intervention Type DRUG

bortezomib

Given subcutaneously.

Intervention Type DRUG

dexamethasone

Given orally

Intervention Type DRUG

cyclophosphamide

Given IV

Intervention Type DRUG

Other Intervention Names

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Doxil Doxorubicin HCl Liposomal Doxorubicin Hydrochloride Liposomal Doxorubicin Hydrochloride Liposome Velcade PS-341 MLN-341 LDP-341 Decadron Hexadrol Dexameth Dexone DXM CTX Cytoxan Neosar

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of multiple myeloma that was symptomatic at the time of initial diagnosis
* Must have met the following criteria at one point during the disease course:

* Bone marrow plasmacytosis with ≥ 10% plasma cells or sheets of plasma cells or biopsy-proven plasmacytoma
* Symptomatic disease at initial diagnosis that prompted the initiation of therapy as well as evidence of end-organ damage at the time of diagnosis, including at least 1 of the following:

* Anemia
* Hypercalcemia
* Bone disease (lytic bone lesions or pathologic fracture)
* Renal dysfunction
* Disease relapsed \< 12 months after autologous stem cell transplantation (SCT)
* Measurable disease, as defined by the presence of ≥ 1 of the following:

* Serum M-spike ≥ 1 g/dL
* Urine M-spike ≥ 200 mg/24 hours
* Involved free light chain (FLC) ≥ 10 mg/dL (provided the serum FLC is abnormal)
* Plasma cells ≥ 30%
* ECOG performance status 0-2
* Negative pregnancy test
* Fertile patients must use effective contraception
* At least 14 days since prior palliative and/or localized radiotherapy
* Left ventricular ejection fraction (LVEF) normal by Echocardiography (ECHO) or multiple-gated acquisition (MUGA) scan
* Hemoglobin \> 8 g/dL
* Platelet count ≥ 75,000/mm\^3 (without transfusion support)
* Absolute neutrophil count (ANC) ≥ 1,000/mm\^3 (without use of growth factors)
* Creatinine \< 2.5 mg/dL
* Direct bilirubin ≤ 1.5 mg/dL
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times upper limit of normal
* All tests below must be performed within 14 days prior to registration:

* Serum free light chain assay
* Kappa free light chain
* Lambda free light chain
* Prior malignancy allowed provided it was treated curatively and has not relapsed in 5 years

* Patients with basal cell skin cancer, in situ cervical cancer, or prostate cancer not requiring therapy are eligible

Exclusion Criteria

* Therapy for relapsed disease following SCT
* Known allergy to bortezomib or anthracyclines
* Prior allogeneic SCT
* Peripheral neuropathy ≥ grade 2 according to the Cancer Therapy Evaluation Program (CTEP) active version of the NCI Common Terminology Criteria for Adverse Events (CTCAE)
* Concurrent uncontrolled illness that would limit study compliance, including the following:

* Uncontrolled hypertension
* Symptomatic congestive heart failure
* Unstable angina
* Uncontrolled cardiac arrhythmia
* Uncontrolled psychiatric illness or social situation
* Active uncontrolled infection
* Prior doxorubicin hydrochloride exposure \> 240 mg/m\^2
* Active, uncontrolled seizure disorder
* Seizures within the past 6 months
* Pregnant or nursing

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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Shaji Kumar, M.D.

Role: STUDY_CHAIR

Mayo Clinic

Locations

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Mayo Clinic in Arizona

Scottsdale, Arizona, 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

Littleton Adventist Hospital

Littleton, 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

Parker Adventist Hospital

Parker, 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

Medical Center of Central Georgia

Macon, Georgia, 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

Eureka Hospital

Eureka, Illinois, United States

Site Status

Illinois CancerCare Galesburg

Galesburg, Illinois, United States

Site Status

Mason District Hospital

Havana, Illinois, United States

Site Status

Mcdonough District Hospital

Macomb, 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

Ottawa Regional Hospital and Healthcare Center

Ottawa, Illinois, United States

Site Status

Pekin Cancer Treatment Center

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 CancerCare-Peoria

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

Perry Memorial Hospital

Princeton, Illinois, United States

Site Status