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

NCT00227682 | Terminated Phase 2

• 4 other identifiers: CDR0000443708OHSU-1277OHSU-HEM-03100-LP30CA069533
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, dexamethasone, and ascorbic acid, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Sometimes when chemotherapy is given, it does not stop the growth of cancer cells. The cancer is said to be resistant to chemotherapy. Giving arsenic trioxide together with chemotherapy may reduce drug resistance and allow the cancer cells to be killed. Thalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Giving arsenic trioxide together with thalidomide, dexamethasone, and ascorbic acid may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving arsenic trioxide together with thalidomide, dexamethasone, and ascorbic acid works in treating patients with relapsed or refractory multiple myeloma.

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

refractory multiple myeloma

Outcome Measures

Primary Outcomes (1)

• Response rate (complete response, partial response, and minimal response) as measured by bone marrow aspirate, biopsy, cytogenetic analysis, serum, urine, and immunofixation skeletal survey at 6 months and end of study treatment

Secondary Outcomes (1)

• Safety and tolerability as measured by physical exams, blood tests, and adverse events reports weekly

Study Arms (1)

Arsenic Trioxide

EXPERIMENTAL

Arsenic Trioxide in Combination With Thalidomide, Dexamethasone, and Ascorbic Acid

Dietary Supplement: ascorbic acid; Drug: arsenic trioxide; Drug: dexamethasone; Drug: thalidomide

Interventions

ascorbic acid DIETARY_SUPPLEMENT

Arsenic Trioxide

arsenic trioxide DRUG

Arsenic Trioxide

dexamethasone DRUG

Arsenic Trioxide

thalidomide DRUG

Arsenic Trioxide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of multiple myeloma (MM) * Relapsed or refractory disease * Monoclonal immunoglobulin spike by serum electrophoresis of ≥ 1 gm/dL AND/OR urine monoclonal immunoglobulin spike of ≥ 200 mg/24 hours * Has received ≥ 2 prior treatment regimens for MM * None of the following are allowed: * Non-secretory MM * Plasma cell leukemia * Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome PATIENT CHARACTERISTICS: Age * Over 18 Performance status * ECOG 0-2 Life expectancy * More than 3 months Hematopoietic * Platelet count ≥ 50,000/mm\^3 (30,000/mm\^3 if the bone marrow is extensively infiltrated) * Hemoglobin ≥ 8.0 g/dL * Absolute neutrophil count ≥ 1,000/mm\^3 Hepatic * AST and ALT \< 3.0 times upper limit of normal (ULN) * Bilirubin \< 2.0 times ULN Renal * Not specified Cardiovascular * No cardiac disease, including any of the following conditions: * History of recurrent supraventricular arrhythmia * History of sustained ventricular tachycardia * History of second or third degree AV block * History of left bundle branch block * Cardiomyopathy with LVEF \< 40% * Uncontrolled ischemic heart disease * No myocardial infarction within the past 6 months * No prolonged QT interval \> 500 ms Other * Not pregnant or nursing * Negative pregnancy test * No HIV positivity * No neuropathy \> grade 3 * Potassium ≥ 4 mEq/L * Magnesium ≥ 1.8 mg/dL PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * More than 30 days since prior investigational drugs

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239-3098, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

Ascorbic Acid; Arsenic Trioxide; Dexamethasone; Thalidomide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Arsenicals; Inorganic Chemicals; Oxides; Oxygen Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Aleksandra Simic, MD

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2005
• First Posted: September 28, 2005
• Study Start: June 1, 2004
• Primary Completion: February 1, 2006
• Study Completion: February 1, 2006
• Last Updated: May 28, 2012

Record last verified: 2010-06

Locations

US (1)