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Phase II Study of the Combination of Bendamustine and Dexamethasone in Patients With Relapsed AL Amyloidosis

Phase 2
18 Years
Not Enrolling
Relapsed AL Amyloidosis

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Trial Information

Phase II Study of the Combination of Bendamustine and Dexamethasone in Patients With Relapsed AL Amyloidosis

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

- 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

- 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the complete hematologic response (CHR).

Outcome Time Frame:

2 years

Safety Issue:



United States: Institutional Review Board

Study ID:




Start Date:

July 2011

Completion Date:

November 2013

Related Keywords:

  • Relapsed AL Amyloidosis
  • Amyloidosis
  • Dexamethasone
  • Bendamustine
  • Amyloidosis



UPMC Cancer Center - Hillman Cancer CenterPittsburgh, Pennsylvania  15232