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Phase II Trial of 4'-IODO-4'-Deoxydoxorubicin in Primary Amyloidosis (AL)

Phase 2
18 Years
Not Enrolling
Multiple Myeloma and Plasma Cell Neoplasm

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Trial Information

Phase II Trial of 4'-IODO-4'-Deoxydoxorubicin in Primary Amyloidosis (AL)

OBJECTIVES: I. Evaluate the clinical efficacy of 4'-iodo-4'-deoxydoxorubicin in producing
palliation of symptoms and/or improvement of organ dysfunction caused by organ infiltration
by amyloid in patients with primary systemic amyloidosis. II. Assess the safety profile,
with emphasis on cardiac safety, of this drug in these patients. III. Evaluate the time to
progression of amyloidosis-associated clinical symptoms and/or organ dysfunction, duration
of response, and survival of these patients on this regimen.

OUTLINE: Patients receive 4'-iodo-4'-deoxydoxorubicin IV over 1 hour once a week for 4
weeks. Courses are repeated every 12 weeks. Treatment continues for up to 4 courses in the
absence of disease progression or unacceptable toxicity. Patients are followed every 6

PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study within 1 year.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histochemically proven primary systemic amyloidosis (AL) No
presence of non-AL amyloidosis No amyloid-specific syndrome (e.g., skin purpura or carpal
tunnel syndrome) as only evidence of disease No vascular amyloid only in a bone marrow
biopsy specimen or in a plasmacytoma Must have symptomatic organ involvement with amyloid
(e.g., liver, mild cardiac, renal, or soft tissue involvement, or grade 1 or 2 peripheral
neuropathy) Demonstrable M-protein in the serum/urine OR Clonal population of plasma cells
in the bone marrow OR Immunohistochemical stain with anti-light chain antisera of amyloid
fibrils No clinically overt multiple myeloma (i.e., monoclonal BMPC greater than 20% and
at least one of the following: bone lesions, anemia, or hypercalcemia)

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-3 Life expectancy:
Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count
at least 100,000/mm3 Hepatic: Total bilirubin less than 2.0 mg/dL OR Direct bilirubin no
greater than 1.0 mg/dL Alkaline phosphatase no greater than 4 times upper limit of normal
(ULN) ALT or AST no greater than 3 times ULN Renal: Creatinine clearance greater than 40
mL/min Cardiovascular: Echocardiographic ejection fraction greater than 50% At least 3
years since prior enzyme documented myocardial infarction Interventricular septal
thickness no greater than 20 mm No New York Heart Association class III or IV heart
failure No grade 2 or 3 A-V block No chronic atrial fibrillation No sustained (greater
than 30 seconds) ventricular tachycardia or frequent episodes (greater than 20 in 24
hours) of nonsustained ventricular tachycardia or ventricular pairs, detected by 24-hour
ambulatory electrocardiographic monitoring Other: Not pregnant or nursing Negative
pregnancy test Fertile patients must use effective contraception HIV positive allowed No
uncontrolled infection No severe diarrhea not controllable with medication or that
requires total parenteral nutrition No other concurrent active malignancy except
nonmelanoma skin cancer or cervical cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 weeks since prior interferon alfa
Chemotherapy: No prior anthracyclines greater than 120 mg/m2 At least 6 weeks since prior
melphalan or other alkylating agents Endocrine therapy: At least 6 weeks since prior high
dose dexamethasone Radiotherapy: Not specified Surgery: Not specified

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Morie A. Gertz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

April 1999

Completion Date:

August 2001

Related Keywords:

  • Multiple Myeloma and Plasma Cell Neoplasm
  • primary systemic amyloidosis
  • Amyloidosis
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma



Mayo Clinic Cancer Center Rochester, Minnesota  55905
University of Arkansas for Medical Sciences Little Rock, Arkansas  72205