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Multiple Myeloma and Plasma Cell NeoplasmPhase 2NCT00017069

Arsenic Trioxide and Dexamethasone in Treating Patients With Recurrent or Refractory Stage II or Stage III Multiple Myeloma

A Phase 2 study testing arsenic trioxide and dexamethasone in people with Multiple Myeloma and Plasma Cell Neoplasm, run by CTI BioPharma at 10 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining arsenic trioxide and dexamethasone in treating patients who have recurrent or… Read more about this study

Who is it for?
Ages 18 to 120 years
What is being tested?
arsenic trioxide and dexamethasone
How many people
Not given
Where
10 sitesUnited States
Study dates
Feb 2001to Jan 2005
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Diagnosis of stage II or III multiple myeloma
  • Refractory myeloma defined as progressive disease (more than 25% increase in M protein or in radiographic findings of nonsecretory myeloma) despite up to 3 courses of prior cytotoxic chemotherapy
  • No more than 3 prior cytotoxic regimens
  • No more than 1 prior high-dose cytotoxic regimen with stem cell transplantation
  • History of disease progression after prior steroid antimyeloma therapy
  • No smoldering myeloma
  • Measurable disease based on presence of serum and urine M protein and/or measurable plasmacytoma

PATIENT CHARACTERISTICS:

Age:

  • Over 18

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • At least 3 months

Hematopoietic:

  • Absolute granulocyte count greater than 1,200/mm^3*
  • Platelet count greater than 75,000/mm^3*
  • Hemoglobin greater than 10 g/dL* NOTE: *Unless due to multiple myeloma

Hepatic:

  • Bilirubin no greater than 2 times upper limit of normal (ULN)
  • SGOT and SGPT no greater than 2 times ULN

Renal:

  • Creatinine no greater than 1.5 times ULN

Cardiovascular:

  • Absolute QT interval less than 460 msec in the presence of normal potassium and magnesium levels
  • No significant underlying cardiac dysfunction
  • No conduction defects
  • No unstable angina
  • No congestive heart failure
  • No New York Heart Association class II-IV cardiac disease
  • No myocardial infarction within the past 6 months

Other:

  • No preexisting grade 2 or greater neurotoxicity/neuropathy
  • No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer
  • No uncontrolled diabetes mellitus
  • No active serious infection uncontrolled by antibiotics
  • No history of grand mal seizures (other than infantile febrile seizures)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics
  • See Chemotherapy
  • At least 28 days since prior biologic therapy

Chemotherapy:

  • See Disease Characteristics
  • At least 28 days since prior cytotoxic chemotherapy, including high-dose cytotoxic regimen with stem cell transplantation
  • No other concurrent cytotoxic chemotherapy

Endocrine therapy:

  • See Disease Characteristics

Radiotherapy:

  • At least 28 days since prior radiotherapy except for focal radiation for symptom control

Surgery:

  • Not specified

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites
  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322

  • Rocky Mountain Cancer Centers - Midtown

    Denver, Colorado, 80218

  • Texas Cancer Care

    Fort Worth, Texas, 76104

  • Mountain States Tumor Institute - Boise

    Meridian, Idaho, 83642

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • St. Joseph Hospital Regional Cancer Center - Orange

    Orange, California, 92868-3849

  • Highlands Oncology Group - Springdale

    Springdale, Arkansas, 72764

  • Stockton Hematology Oncology Medical Group

    Stockton, California, 95204

  • Pasco Pinellas Cancer Center - Tarpon Springs

    Tarpon Springs, Florida, 34689

  • Arizona Clinical Research Center

    Tucson, Arizona, 85712

Other trials in United States

About this study

Official title: CTI 1060: A Phase II Clinical Trial of Arsenic Trioxide and Dexamethasone as Therapy for Relapsed or Refractory Multiple Myeloma

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combining arsenic trioxide and dexamethasone in treating patients who have recurrent or refractory stage II or stage III multiple myeloma.

Read the detailed description

OBJECTIVES:

  • Determine the response rate of patients with recurrent or refractory stage II or III multiple myeloma treated with arsenic trioxide and dexamethasone.
  • Determine the rates of overall and relapse-free survival in patients treated with this regimen.
  • Determine the safety profile of this treatment regimen in these patients.

OUTLINE: Patients receive arsenic trioxide IV daily for 5 days during the first week only and then 2 days a week thereafter. Patients also receive IV or oral dexamethasone on days 1-4 every 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Disease assessments are conducted every 4 weeks. Patients achieving complete response (CR) receive 2 additional courses of therapy after initial determination of CR.

Final assessments are conducted 4 weeks after the last study treatment and then annually thereafter.

PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.

Being tested
arsenic trioxide, dexamethasone
Keywords
refractory multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
Medical subject headings
Multiple Myeloma, Neoplasms, Plasma Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startFeb 2001
  3. Primary completionJan 2005
  4. Study completionJan 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00017069
Sponsor's protocol ID
CTI-1060
Other IDs
CDR0000068646, MSKCC-01012, NCI-G01-1951
Status last verified
Oct 2020
First submitted
6 Jun 2001
Last updated
5 Oct 2020
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing arsenic trioxide and dexamethasone in people with Multiple Myeloma and Plasma Cell Neoplasm, run by CTI BioPharma at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2020.

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