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Phase II Study of Melphalan, Arsenic Trioxide, and Ascorbic Acid in Patients With Relapsed or Refractory Multiple Myeloma


Phase 2
18 Years
N/A
Not Enrolling
Both
Stage II Multiple Myeloma, Stage III Multiple Myeloma, Refractory Plasma Cell Neoplasm

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Trial Information

Phase II Study of Melphalan, Arsenic Trioxide, and Ascorbic Acid in Patients With Relapsed or Refractory Multiple Myeloma


OBJECTIVES:

Primary

- Determine the time to progression in patients with relapsed or refractory multiple
myeloma (MM) treated with melphalan, arsenic trioxide, and ascorbic acid.

- Determine the response rate (combined complete response, partial response, and minimal
response) in patients treated with this regimen.

- Determine the safety and tolerability of this regimen in these patients.

Secondary

- Determine the time to response and overall survival of patients treated with this
regimen.

- Determine the effects of this regimen on renal failure associated with MM in these
patients.

OUTLINE: This is an open-label, non-randomized, multicenter study.

Patients receive oral melphalan once daily on days 1-4 of week 1 and arsenic trioxide (ATO)
IV over 1-2 hours and ascorbic acid IV over 15 minutes on days 1-4 of week 1 and then twice
weekly during weeks 2-5. Treatment repeats every 6 weeks for up to 6 courses in the absence
of disease progression or unacceptable toxicity. Patients with disease progression any time
after course 1 also receive oral prednisone once daily on days 1-4 and 22-25 of each course.
Patients achieving a complete response after 6 courses of therapy undergo bone marrow biopsy
and receive no further therapy. Patients achieving stable disease or a partial response
after 6 courses of therapy continue to receive ATO and ascorbic acid once weekly.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of multiple myeloma meeting at least 1 of the following criteria:

- Relapsed disease after a response to standard first-line chemotherapy (e.g.,
vincristine, doxorubicin, and dexamethasone [VAD] OR melphalan and prednisone) or
first-line high-dose chemotherapy

- Refractory disease (failed to achieve at least stable disease) to most recent
chemotherapy with or without systemic corticosteroids

- Measurable disease, defined as a monoclonal immunoglobulin spike on serum
electrophoresis of ≥ 1 g/dL AND/OR urine monoclonal immunoglobulin spike of ≥ 200
mg/24 hours

- No non-secretory myeloma

- No plasma cell leukemia

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Karnofsky 60-100%

Life expectancy

- More than 3 months

Hematopoietic

- Platelet count ≥ 50,000/mm^3 (30,000/mm^3 if bone marrow is extensively infiltrated)

- Hemoglobin ≥ 8.0 g/dL

- Absolute neutrophil count ≥ 1,000/mm^3

- Pancytopenia secondary to multiple myeloma or hypersplenism allowed

Hepatic

- AST and ALT ≤ 3 times upper limit of normal (ULN)

- Bilirubin ≤ 2 times ULN (unless clearly related to disease)

- No known active hepatitis B or C infection

Renal

- Calcium < 14 mg/dL

Cardiovascular

- No evidence of acute ischemia or new conduction system abnormality by
electrocardiogram

- No myocardial infarction within the past 6 months

- No New York Heart Association class III or IV heart failure

- No poorly controlled hypertension

- No prolonged corrected QT interval (> 460 ms) with potassium > 4 mmol/L and magnesium
≥ 1.8 mmol/L

Other

- No active infection

- No POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly,
endocrinopathy, monoclonal protein, and skin changes)

- No diabetes mellitus

- No other serious medical or psychiatric illness that would preclude study
participation

- No known allergic reaction attributable to compounds of similar chemical or
biological composition to study drugs

- No history of grand mal seizures

- HIV negative

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

- More than 4 weeks since prior immunotherapy or antibody therapy

Chemotherapy

- See Disease Characteristics

- More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)

Endocrine therapy

- See Disease Characteristics

- No other concurrent corticosteroids

Radiotherapy

- More than 4 weeks since prior radiotherapy

Surgery

- More than 4 weeks since prior major surgery

Other

- No other concurrent investigational agents

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

James R. Berenson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Oncotherapeutics

Authority:

United States: Federal Government

Study ID:

CDR0000368637

NCT ID:

NCT00085345

Start Date:

Completion Date:

Related Keywords:

  • Stage II Multiple Myeloma
  • Stage III Multiple Myeloma
  • Refractory Plasma Cell Neoplasm
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma

Name

Location

Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283
Tulane Cancer Center at Tulane University Hospital and ClinicNew Orleans, Louisiana  70112
Hackensack University Medical Center Cancer CenterHackensack, New Jersey  07601
William Beaumont Hospital - Royal Oak CampusRoyal Oak, Michigan  48073
Comprehensive Blood and Cancer CenterBakersfield, California  93309
Mount Sinai Comprehensive Cancer Center at Mount Sinai Medical CenterMiami Beach, Florida  33140
Fountain Valley, California  92708
Palo Verde Hematology OncologyGlendale, Arizona  85304
OncotherapeuticsLos Angeles, California  90067
Southbay Oncology / Hematology Medical GroupCampbell, California  95008
Hematology-Oncology Medical Group of Fresno, IncorporatedFresno, California  93720
Hematology Oncology Medical Group of Orange County, IncorporatedOrange, California  92868
Cancer Care Associates Medical Group - Redondo BeachRedondo Beach, California  90277
Redwood Regional Oncology Center - SotoyomeSanta Rosa, California  95405
Cancer Prevention and Treatment Center at Dominican and Watsonville Community HospitalSoquel, California  95073
San Diego Cancer Center - VistaVista, California  92083
Atlanta Cancer Care - RoswellRoswell, Georgia  30076
Center for Cancer and Blood Disorders at Suburban HospitalBethesda, Maryland  20817
Utah Cancer Specialists - Administrative OfficeSalt Lake City, Utah  84106