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WithdrawnNCT00085345Updated Jul 10, 2013

Melphalan, Arsenic Trioxide, and Ascorbic Acid in Treating Patients With Relapsed or Refractory Multiple Myeloma

A Phase 2 interventional study of arsenic trioxide and ascorbic acid in Stage II Multiple Myeloma, Stage III Multiple Myeloma and Refractory Plasma Cell Neoplasm, sponsored by Oncotherapeutics. Withdrawn at 19 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-07-10.

Sponsored by Oncotherapeutics · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
0
Ages
18 Years and older
Sex
All
01

Study summary

RATIONALE: Drugs used in chemotherapy, such as melphalan, arsenic trioxide, and ascorbic acid, work in different ways to stop cancer cells from dividing so they stop growing or die. Arsenic trioxide and ascorbic acid may also help melphalan kill more cancer cells by making them more sensitive to the drugs.

PURPOSE: This phase II trial is studying how well giving melphalan together with arsenic trioxide and ascorbic acid works in treating patients with relapsed or refractory multiple myeloma.

Read the detailed description

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.

02

Conditions studied

  • Stage II Multiple Myeloma
  • Stage III Multiple Myeloma
  • Refractory Plasma Cell Neoplasm
03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

Browse Multiple Myeloma studies →

Lead sponsor

Oncotherapeutics is the lead sponsor of 22 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Enrollment
0 participants (actual)

Interventions

  • Drugarsenic trioxide
  • Drugascorbic acid
  • Drugmelphalan
  • Procedurechemosensitization/potentiation
  • Procedurechemotherapy
06

Study locations

19 sites
  • Palo Verde Hematology Oncology
    Glendale, Arizona 85304, United States
  • Comprehensive Blood and Cancer Center
    Bakersfield, California 93309-0633, United States
  • Southbay Oncology / Hematology Medical Group
    Campbell, California 95008, United States
  • Fountain Valley, California 92708, United States
  • Hematology-Oncology Medical Group of Fresno, Incorporated
    Fresno, California 93720, United States
  • Hematology Oncology Medical Group of Orange County, Incorporated
    Orange, California 92868, United States
  • Cancer Care Associates Medical Group - Redondo Beach
    Redondo Beach, California 90277, United States
  • Redwood Regional Oncology Center - Sotoyome
    Santa Rosa, California 95405, United States
  • Cancer Prevention and Treatment Center at Dominican and Watsonville Community Hospital
    Soquel, California 95073, United States
  • San Diego Cancer Center - Vista
    Vista, California 92083, United States
  • Oncotherapeutics
    West Hollywood, California 90069, United States
  • Mount Sinai Comprehensive Cancer Center at Mount Sinai Medical Center
    Miami Beach, Florida 33140, United States
  • Atlanta Cancer Care - Roswell
    Roswell, Georgia 30076, United States
  • Tulane Cancer Center at Tulane University Hospital and Clinic
    New Orleans, Louisiana 70112-2699, United States
  • Center for Cancer and Blood Disorders at Suburban Hospital
    Bethesda, Maryland 20817, United States
  • William Beaumont Hospital - Royal Oak Campus
    Royal Oak, Michigan 48073, United States
  • Hackensack University Medical Center Cancer Center
    Hackensack, New Jersey 07601, United States
  • Abramson Cancer Center of the University of Pennsylvania
    Philadelphia, Pennsylvania 19104-4283, United States
  • Utah Cancer Specialists - Administrative Office
    Salt Lake City, Utah 84106, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00085345
Lead sponsor
Oncotherapeutics
First posted
Jun 11, 2004
Last update
Jul 10, 2013

Study contacts

James R. Berenson, MD
study chair · Oncotherapeutics
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jul 2006. You cannot join it, but the record below documents what was studied.

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