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A Phase II Study of Bortezomib, Liposomal Doxorubicin, Dexamethasone, and Cyclophosphamide in Patients With Multiple Myeloma Relapsing Within 12 Months of Autologous Stem Cell Transplant


Phase 2
18 Years
N/A
Not Enrolling
Both
Refractory Multiple Myeloma

Thank you

Trial Information

A Phase II Study of Bortezomib, Liposomal Doxorubicin, Dexamethasone, and Cyclophosphamide in Patients With Multiple Myeloma Relapsing Within 12 Months of Autologous Stem Cell Transplant


PRIMARY OBJECTIVES:

I. To evaluate the 1-year survival of patients with relapsed multiple myeloma treated with
bortezomib, pegylated liposomal doxorubicin hydrochloride, 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 IV on days 1, 4, 8, and 11; pegylated liposomal doxorubicin
hydrochloride IV over 1 hour on day 4; oral dexamethasone on days 1, 2, 4, 5, 8, 9, 11, and
12; and cyclophosphamide IV over 2 hours on day 1. Treatment repeats every 21 days for up to
12 courses in the absence of disease progression or unacceptable toxicity.

Peripheral blood and bone marrow samples may be collected for future research. Patients
complete the FACT neurotoxicity questionnaire periodically.

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


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)

- No more than two lines of prior therapy for multiple myeloma, including the
autologous SCT (autologous SCT, preceding induction therapy, and any maintenance
therapy will be considered one line of therapy)

- No therapy for relapsed disease following 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

- Hemoglobin > 8 g/dL

- Platelet count ≥ 75,000/mm^3 (without transfusion support)

- ANC ≥ 1,000/mm^3 (without use of growth factors)

- Creatinine < 2.5 mg/dL

- Direct bilirubin ≤ 1.5 mg/dL

- ALT and AST ≤ 2.5 times upper limit of normal

- LVEF normal by ECHO or MUGA scan

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No active, uncontrolled seizure disorder

- No seizures within the past 6 months

- No 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

- No peripheral neuropathy ≥ grade 2 according to the CTEP active version of the NCI
CTCAE

- 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

- No known allergy to bortezomib or anthracyclines

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

- No prior allogeneic SCT

- No prior doxorubicin hydrochloride exposure > 240 mg/m^2

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

One-year overall survival

Outcome Description:

Estimated using the method of Kaplan and Meier

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Shaji Kumar

Investigator Role:

Principal Investigator

Investigator Affiliation:

Eastern Cooperative Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2011-02002

NCT ID:

NCT01078441

Start Date:

September 2010

Completion Date:

Related Keywords:

  • Refractory Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Mayo Clinic Rochester, Minnesota  55905
Boulder Community Hospital Boulder, Colorado  80301-9019
Porter Adventist Hospital Denver, Colorado  80210
Rose Medical Center Denver, Colorado  80220
Swedish Medical Center Englewood, Colorado  80110
Sky Ridge Medical Center Lone Tree, Colorado  80124
North Suburban Medical Center Thornton, Colorado  80229
Fairview Ridges Hospital Burnsville, Minnesota  55337
Hutchinson Area Health Care Hutchinson, Minnesota  55350
United Hospital St. Paul, Minnesota  55102
Ridgeview Medical Center Waconia, Minnesota  55387
Geisinger Medical Center Danville, Pennsylvania  17822-0001
Methodist Medical Center of Illinois Peoria, Illinois  61636
Via Christi Regional Medical Center Wichita, Kansas  67214
Iowa Methodist Medical Center Des Moines, Iowa  50309
Iowa Lutheran Hospital Des Moines, Iowa  50316-2301
Medical Center of Central Georgia Macon, Georgia  31201
University of Wisconsin Hospital and Clinics Madison, Wisconsin  53792-0001
MetroHealth Medical Center Cleveland, Ohio  44109
North Colorado Medical Center Greeley, Colorado  80631
McKee Medical Center Loveland, Colorado  80539
Cancer Center of Kansas - Chanute Chanute, Kansas  66720
Cancer Center of Kansas - Dodge City Dodge City, Kansas  67801
Cancer Center of Kansas - Newton Newton, Kansas  67114
Cancer Center of Kansas - Salina Salina, Kansas  67042
Cancer Center of Kansas - Wellington Wellington, Kansas  67152
Associates in Womens Health Wichita, Kansas  67203
Cancer Center of Kansas - Winfield Winfield, Kansas  67156
Beebe Medical Center Lewes, Delaware  19958
Memorial Hospital Carthage, Illinois  62321
Mason District Hospital Havana, Illinois  62644
McDonough District Hospital Macomb, Illinois  61455
BroMenn Regional Medical Center Normal, Illinois  61761
Proctor Hospital Peoria, Illinois  61614
Perry Memorial Hospital Princeton, Illinois  61356
Community Cancer Center of Monroe Monroe, Michigan  48162
Lima Memorial Hospital Lima, Ohio  45804
Mercy Hospital of Tiffin Tiffin, Ohio  44883
Fulton County Health Center Wauseon, Ohio  43567
Exempla Lutheran Medical Center Wheat Ridge, Colorado  80033
Eureka Hospital Eureka, Illinois  61530
Mercy Hospital Coon Rapids, Minnesota  55433
Graham Hospital Association Canton, Illinois  61520
Saint Joseph Medical Center Joliet, Illinois  60435
Medical Oncology and Hematology Associates Des Moines, Iowa  50309
Bixby Medical Center Adrian, Michigan  49221
Fairview-Southdale Hospital Edina, Minnesota  55435
Abbott-Northwestern Hospital Minneapolis, Minnesota  55407
Regions Hospital Saint Paul, Minnesota  55101
Saint Francis Regional Medical Center Shakopee, Minnesota  55379
Rice Memorial Hospital Willmar, Minnesota  56201
Geisinger Medical Group State College, Pennsylvania  16801
Cancer Center of Kansas - Fort Scott Fort Scott, Kansas  66701
Cancer Center of Kansas-Independence Independence, Kansas  67301
Lawrence Memorial Hospital Lawrence, Kansas  66044
Fisher-Titus Medical Center Norwalk, Ohio  44857
UW Cancer Center Johnson Creek Johnson Creek, Wisconsin  53038
Longmont United Hospital Longmont, Colorado  80501
Union Hospital of Cecil County Elkton MD, Maryland  21921
Mayo Clinic in Arizona Scottsdale, Arizona  85259-5404
Hennepin County Medical Center Minneapolis, Minnesota  
Cancer Center of Kansas - McPherson McPherson, Kansas  67460
Presbyterian - Saint Lukes Medical Center - Health One Denver, Colorado  80218
Wichita CCOP Wichita, Kansas  67214-3882
Flower Hospital Sylvania, Ohio  43560-2197
Metro-Minnesota CCOP St. Louis Park, Minnesota  
Lakeview Hospital Stillwater, Minnesota  55082
Butler Memorial Hospital Butler, Pennsylvania  16001
Littleton Adventist Hospital Littleton, Colorado  80122
Parker Adventist Hospital Parker, Colorado  80138
New Ulm Medical Center New Ulm, Minnesota  56073
OSF Saint Francis Medical Center Peoria, Illinois  61637
The Medical Center of Aurora Aurora, Colorado  80012
Penrose-Saint Francis Healthcare Colorado Springs, Colorado  80907
Saint Anthony Central Hospital Denver, Colorado  80204
Exempla Saint Joseph Hospital Denver, Colorado  80218
Colorado Cancer Research Program CCOP Denver, Colorado  80224-2522
Saint Mary's Hospital and Regional Medical Center Grand Junction, Colorado  81502
Saint Mary Corwin Medical Center Pueblo, Colorado  81004
Community Cancer Center Foundation Normal, Illinois  61761
Ottawa Regional Hospital and Healthcare Center Ottawa, Illinois  61350
Pekin Cancer Treatment Center Pekin, Illinois  61554
Illinois Oncology Research Association CCOP Peoria, Illinois  61615
Illinois CancerCare-Peoria Peoria, Illinois  61615
Illinois Valley Hospital Peru, Illinois  61354
Medical Oncology and Hematology Associates-West Des Moines Clive, Iowa  50325
Iowa Oncology Research Association CCOP Des Moines, Iowa  50309
Mercy Medical Center - Des Moines Des Moines, Iowa  50314
Medical Oncology and Hematology Associates-Des Moines Des Moines, Iowa  50309
Mercy Medical Center - North Iowa Mason City, Iowa  50401
Mercy Medical Center-Sioux City Sioux City, Iowa  51104
Saint Luke's Regional Medical Center Sioux City, Iowa  51104
Cancer Center of Kansas - El Dorado El Dorado, Kansas  67042
Cancer Center of Kansas-Kingman Kingman, Kansas  67068
Cancer Center of Kansas - Parsons Parsons, Kansas  67357
Cancer Center of Kansas - Pratt Pratt, Kansas  67124
Cancer Center of Kansas-Wichita Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas - Main Office Wichita, Kansas  67214
Hickman Cancer Center Adrian, Michigan  49221
Mercy Memorial Hospital Monroe, Michigan  48162
Unity Hospital Fridley, Minnesota  55432
Saint John's Hospital - Healtheast Maplewood, Minnesota  55109
Minnesota Oncology Hematology PA-Maplewood Maplewood, Minnesota  55109
North Memorial Medical Health Center Robbinsdale, Minnesota  55422
Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota  55416
Minnesota Oncology and Hematology PA-Woodbury Woodbury, Minnesota  55125
Cooper Hospital University Medical Center Camden, New Jersey  08103
Hematology Oncology Center Incorporated Elyria, Ohio  44035
Saint Charles Hospital Oregon, Ohio  43616
North Coast Cancer Care Sandusky, Ohio  44870
Toledo Community Hospital Oncology Program CCOP Toledo, Ohio  43617
Mercy Cancer Center at Saint Anne Mercy Hospital Toledo, Ohio  43623
University of Toledo Toledo, Ohio  43614
Saint Vincent Mercy Medical Center Toledo, Ohio  43608
Geisinger Wyoming Valley Wilkes-Barre, Pennsylvania  18711
Fredericksburg Oncology Inc Fredericksburg, Virginia  22401
Cancer Center of Kansas-Liberal Liberal, Kansas  67901
North Coast Cancer Care-Clyde Clyde, Ohio  43410
Community Health Partners Regional Medical Center Elyria, Ohio  44035
The Jewish Hospital Cincinnati, Ohio  45236
Siouxland Hematology Oncology Associates Sioux City, Iowa  51101
Eastern Cooperative Oncology Group Boston, Massachusetts  02215
The Toledo Hospital/Toledo Children's Hospital Toledo, Ohio  43606
Toledo Clinic Cancer Centers-Oregon Oregon, Ohio  43616
Geisinger Medical Center-Cancer Center Hazelton Hazleton, Pennsylvania  18201
Illinois CancerCare Galesburg Galesburg, Illinois  61401
Christiana Care Health System-Christiana Hospital Newark, Delaware  19718
Toledo Clinic Cancer Centers-Bowling Green Bowling Green, Ohio  43402
Toledo Clinic Cancer Centers-Maumee Maumee, Ohio  43537-1839
Toledo Clinic Cancer Centers-Toledo Toledo, Ohio  43623