Bendamustine and Dexamethasone in Patients With Relapsed AL Amyloidosis

Description

The study is being done to see if the combination of bendamustine and dexamethasone will help people with amyloidosis that has returned after standard treatment. Bendamustine is currently approved by the Food and Drug Administration (FDA) for treatment of chronic lymphocytic leukemia (CLL) and is under clinical development in the United States for the treatment of non-Hodgkin lymphoma (NHL). Dexamethasone is a synthetic (man-made) steroid with powerful anti-inflammatory effects. It can also alter the body's immune response.

Study Start Date

June 2012

Estimated Completion Date

December 2016

Interventions

  • Drug: Bendamustine
  • Drug: Dexamethasone

Specialties

  • Oncology: Leukemia/Lymphoma

MeSH Terms

  • Amyloidosis
  • Bendamustine
  • Dexamethasone

Study ID

University of Pittsburgh -- 10-012

Status

Unknown

Trial ID

NCT01222260

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

40

Sponsor

University of Pittsburgh

Inclusion Criteria

  • Male or female patients aged >= 18 years old
  • Histopathology of amyloidosis or light chain deposition disease based on detection by polarizing microscopy of green bi-refringent material in Congo red-stained tissue specimens or characteristic electron microscopy appearance
  • Demonstrate measurable disease as defined by one or more of the following:
  • Serum monoclonal protein >= 0.5 g/dL by serum electrophoresis
  • Urine monoclonal protein > 200 mg/dL in a 24 hr urine electrophoresis
  • Serum immunoglobulin free light chain >= 10 mg/dL AND abnormal serum immunoglobulin kappa lambda free light chain ratio.
  • Demonstrate clonal population of plasma cells in the bone marrow or immunohistochemical stain with anti-light chain anti-sera of amyloid fibrils
  • ECOG performance status of 0, 1, or 2
  • Patients had at least one prior regimen consisting of at least 1 cycle
  • If not previously transplanted, patient should be either ineligible for ASCT, or must have declined the option of ASCT. Patients who have previously had ASCT and have subsequently progressed are eligible, provided other entry criteria are met
  • Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
  • Patients must meet the following laboratory criteria:
  • ANC >= 1.5 x 10^9/L
  • Hemoglobin >= 9 g/dl (May transfuse PRBC to meet parameter)
  • Platelets >= 100x 10^9/L (Must be independent of platelet transfusion)
  • Calculated CrCl greater than or equal to 40 mL/min (Cockcroft-Gault Formula )
  • AST and ALT <= 2.5 x upper limit of normal (ULN)
  • Serum bilirubin <1.5 x ULN
  • Albumin > 3.0 g/dl
  • Serum potassium >= lower limit of normal (LLN)
  • Total serum calcium (corrected for serum albumin) or ionized calcium >= LLN,
  • Serum magnesium >= LLN
  • Serum phosphorus >= LLN
  • TSH and free T4 within normal limits. Patients are permitted to receive thyroid hormone supplements to treat underlying hypothyroidism.

Exclusion Criteria

  • Patients meeting the criteria for symptomatic MM:
  • lytic lesions on skeletal survey or
  • plasmacytoma Patients meeting International Myeloma Working Group definition of symptomatic myeloma with symptoms only related to associated amyloidosis who would otherwise only meet the criteria for smoldering MM are potentially eligible
  • Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure uncontrolled angina, severe uncontrolled ventricular arrhythmias, or
  • electrocardiographic evidence of acute ischemia or active conduction system abnormalities (not including 1st degree AV-block, Wenckebach type 2nd degree heart block, or left bundle branch block. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator or an authorized physician sub-investigator as not medically relevant). Note: There is no lower limit of left ventricular ejection fraction below which patients are excluded from participation.
  • Patient has received other investigational drugs within 14 days prior to enrollment
  • Any form of secondary / familial amyloidosis
  • Serious concurrent illness, which in the opinion of the investigator or an authorized physician sub-investigator would interfere with participation in this clinical study,
  • Known HIV infection.
  • Inability to provide informed consent or to comply with the schedule of office and treatment visits
  • Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women(woman not of child-bearing potential is defined as any woman whose menstrual periods have stopped in the past 12 consecutive months or have had a complete hysterectomy or both ovaries surgically removed).
  • Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, low-risk prostate cancer, or cancer after curative treatment.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (10)

Study Location Distance Name Phone Email
Columbia University - New York, New York 44.8 miles Ryan Shelton 212-304-5485 None
Columbia University - New York, New York 44.8 miles None None None
Mt Sinai Medical Center - New York, New York 49.1 miles Lisa La 212-241-8615 lisa.la@mssm.edu
Mt Sinai Medical Center - New York, New York 49.1 miles None None None
Memorial SloanKettering Cancer Center - New York, New York 50.7 miles None None None
Memorial SloanKettering Cancer Center - New York, New York 50.7 miles Heather Landau MD 646-497-9062 None
Boston Medical Center - Boston, Massachusetts 137.1 miles None None None
Tufts Medical Center - Boston, Massachusetts 137.7 miles None None None
Tufts Medical Center - Boston, Massachusetts 137.7 miles Jodi Jensen 617-636-5558 jjensen@tuftsmedicalcenter.org
Barbara Ann Karmanos Cancer Institute - Detroit, Michigan 512.3 miles None None None

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