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.
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
- Conditions the study is for
- Multiple Myeloma and Plasma Cell Neoplasm
- 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
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.
arsenic trioxideDrug
dexamethasoneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startFeb 2001
- Primary completionJan 2005
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma and Plasma Cell NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- CTI BioPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Scott C. Stromatt, MD, Study chair, CTI BioPharma
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CTI 1060: A Phase II Clinical Trial of Arsenic Trioxide and Dexamethasone as Therapy for Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00017069
- Acronym / sponsor ID
- CTI-1060
- Keywords
- refractory multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Lead sponsor
- CTI BioPharmaIndustry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2001 (actual)
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| arsenic trioxide | Drug | – |
| dexamethasone | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott C. Stromatt, MD study chair
CTI BioPharma
10 sites in 1 country: see every site and its status.
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.