Stage I Multiple MyelomaPhase 2NCT00112879
Arsenic Trioxide, Ascorbic Acid, Dexamethasone, and Thalidomide in Treating Patients With Multiple Myeloma
A Phase 2 study testing arsenic trioxide, ascorbic acid and dexamethasone in people with Stage I Multiple Myeloma and Stage II Multiple Myeloma, run by The Cleveland Clinic at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Thalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma
- What is being tested?
- arsenic trioxide, ascorbic acid and dexamethasone
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of multiple myeloma (MM), meeting 1 of the following criteria:
- Previously untreated disease with poor prognosis, meeting 1 of the following criteria:
- Active disease with β2 microglobulin ≥ 5.5 mg/dL
- Inactive disease with peripheral plasma cells OR chromosome 13 or 14 abnormalities by fluorescent in situ hybridization
- Relapsed or refractory disease
- Measurable disease by serum and urine M-protein and/or measurable plasmacytoma
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2* NOTE: *ECOG 3 allowed for patients with bone pain due to MM
Life expectancy
- At least 3 months
Hematopoietic
- Platelet count ≥ 75,000/mm^3 unless plasma cells > 50% in bone marrow
- Any WBC allowed provided plasma cells > 50% in bone marrow
Hepatic
- SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN)
- Bilirubin ≤ 2.5 times ULN
Renal
- Creatinine ≤ 6.0 mg/dL
Cardiovascular
- Absolute QT interval ≤ 460 msec with potassium ≥ 4.0 mEq/L AND magnesium ≥ 1.8 mg/dL
- No conduction defects
- No unstable angina
- No myocardial infarction within the past 6 months
- No congestive heart failure
- No New York Heart Association class II-IV heart disease
- No other significant underlying cardiac dysfunction
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective double-method contraception for ≥ 4 weeks before, during, and for ≥ 4 weeks after completion of study therapy
- No blood, ova, or sperm donation during study participation
- No history of grand mal seizures except infantile febrile seizures
- No pre-existing neurotoxicity or neuropathy ≥ grade 2
- No uncontrolled diabetes mellitus
- No active serious infection that cannot be controlled with antibiotics
- No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer
- No other condition that would preclude study compliance or follow up
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Prior thalidomide allowed (in patients with relapsed or refractory MM)
- No prior thalidomide in combination with arsenic trioxide
- Prior epoetin alfa allowed
Chemotherapy
- See Biologic therapy
- Prior arsenic trioxide allowed (for patients with relapsed or refractory MM)
- No concurrent cytotoxic chemotherapy
- No chemotherapy within 2 weeks after completion of study treatment
Endocrine therapy
- Prior steroid therapy allowed (for patients with relapsed or refractory MM)
Radiotherapy
- No concurrent broad-field radiotherapy
Surgery
- Not specified
Other
- Prior and concurrent bisphosphonates allowed
- No other concurrent investigational agents
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
About this study
Official title: Phase II Study of Arsenic Trioxide, Ascorbic Acid, Dexamethasone, and Thalidomide in Patients With Previously Untreated High-Risk or Relapsed or Refractory Multiple Myeloma
RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Thalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Giving arsenic trioxide together with ascorbic acid, dexamethasone, and thalidomide may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving arsenic trioxide together with ascorbic acid, dexamethasone, and thalidomide work in treating patients with multiple myeloma.
Read the detailed description
OBJECTIVES:
Primary
- Determine the response rate in patients with previously untreated high-risk or relapsed or refractory multiple myeloma (MM) treated with arsenic trioxide, ascorbic acid, dexamethasone, and thalidomide.
- Determine the safety of this regimen in these patients.
Secondary
- Determine the duration of response, progression-free survival, and overall survival of patients with previously untreated high-risk MM treated with this regimen.
OUTLINE: This is an open-label study.
- Induction therapy: Patients receive arsenic trioxide IV over 1-4 hours and ascorbic acid IV over 15-30 minutes on days 1-5 in week 1 and then twice weekly in weeks 2-12; oral dexamethasone on days 1-4, 11-14, 29-32, 39-42, 57-60, and 67-70 (weeks 1, 2, 5, 6, 9, and 10); and oral thalidomide once daily in weeks 1-12.
- Consolidation therapy: Beginning 4 weeks after completion of induction therapy, patients receive arsenic trioxide and ascorbic acid as in induction therapy; oral dexamethasone on days 1-4, 29-32, and 57-60 (weeks 1, 5, and 9); and oral thalidomide once daily in weeks 1-12.
- Maintenance therapy: Beginning 4 weeks after completion of consolidation therapy, patients receive arsenic trioxide IV over 1-4 hours and ascorbic acid IV over 15-30 minutes on days 1, 8, 15, and 22. Treatment with arsenic trioxide and ascorbic acid repeats every 90 days (every 12 weeks). Patients also receive oral dexamethasone on days 1-4. Treatment with dexamethasone repeats every 28 days. Patients receive oral thalidomide once daily. Maintenance therapy continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 4 weeks and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 33-68 patients (15-34 with previously untreated high-risk multiple myeloma [MM] and 18-34 with relapsed or refractory MM) will be accrued for this study.
- Conditions
- Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma, Refractory Plasma Cell Neoplasm
- Being tested
- arsenic trioxide, ascorbic acid, dexamethasone, thalidomide, anti-cytokine therapy
- 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
ascorbic acidDrug
dexamethasoneDrug
thalidomideDrug
anti-cytokine therapyProcedure or surgery
antiangiogenesis therapyProcedure or surgery
biological therapyProcedure or surgery
chemotherapyProcedure or surgery
drug resistance inhibitionProcedure or surgery
growth factor antagonist therapyProcedure or surgery
non-specific immune-modulator therapyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage I Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Mohamad A. Hussein, MD, Study chair, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00112879
- Sponsor's protocol ID
- CCF-IRB-7469
- Other IDs
- CDR0000428248, CCF-IRB-5241, CCF-CTI-T12016
- Status last verified
- Dec 2006
- First submitted
- 2 Jun 2005
- Last updated
- 10 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Arsenic Trioxide, Ascorbic Acid, Dexamethasone, and Thalidomide in Patients With Previously Untreated High-Risk or Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00112879
- Acronym / sponsor ID
- CCF-IRB-7469
- Conditions
- Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma, Refractory Plasma Cell Neoplasm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- First posted
- 3 Jun 2005 (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, such as arsenic trioxide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Thalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Giving arsenic trioxide together with ascorbic acid, dexamethasone, and thalidomide may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving arsenic trioxide together with ascorbic acid, dexamethasone, and thalidomide work in treating patients with multiple myeloma.
Detailed description
OBJECTIVES:
Primary
- Determine the response rate in patients with previously untreated high-risk or relapsed or refractory multiple myeloma (MM) treated with arsenic trioxide, ascorbic acid, dexamethasone, and thalidomide.
- Determine the safety of this regimen in these patients.
Secondary
- Determine the duration of response, progression-free survival, and overall survival of patients with previously untreated high-risk MM treated with this regimen.
OUTLINE: This is an open-label study.
- Induction therapy: Patients receive arsenic trioxide IV over 1-4 hours and ascorbic acid IV over 15-30 minutes on days 1-5 in week 1 and then twice weekly in weeks 2-12; oral dexamethasone on days 1-4, 11-14, 29-32, 39-42, 57-60, and 67-70 (weeks 1, 2, 5, 6, 9, and 10); and oral thalidomide once daily in weeks 1-12.
- Consolidation therapy: Beginning 4 weeks after completion of induction therapy, patients receive arsenic trioxide and ascorbic acid as in induction therapy; oral dexamethasone on days 1-4, 29-32, and 57-60 (weeks 1, 5, and 9); and oral thalidomide once daily in weeks 1-12.
- Maintenance therapy: Beginning 4 weeks after completion of consolidation therapy, patients receive arsenic trioxide IV over 1-4 hours and ascorbic acid IV over 15-30 minutes on days 1, 8, 15, and 22. Treatment with arsenic trioxide and ascorbic acid repeats every 90 days (every 12 weeks). Patients also receive oral dexamethasone on days 1-4. Treatment with dexamethasone repeats every 28 days. Patients receive oral thalidomide once daily. Maintenance therapy continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 4 weeks and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 33-68 patients (15-34 with previously untreated high-risk multiple myeloma [MM] and 18-34 with relapsed or refractory MM) will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- 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 | – |
| ascorbic acid | Drug | – |
| dexamethasone | Drug | – |
| thalidomide | Drug | – |
| anti-cytokine therapy | Procedure or surgery | – |
| antiangiogenesis therapy | Procedure or surgery | – |
| biological therapy | Procedure or surgery | – |
| chemotherapy | Procedure or surgery | – |
| drug resistance inhibition | Procedure or surgery | – |
| growth factor antagonist therapy | Procedure or surgery | – |
| non-specific immune-modulator therapy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2013.
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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.
Mohamad A. Hussein, MD study chair
The Cleveland Clinic
1 site 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, ascorbic acid and dexamethasone in people with Stage I Multiple Myeloma and Stage II Multiple Myeloma, run by The Cleveland Clinic at 1 site 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: withdrawn, as of the sponsor's last update on 10 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 withdrawn before enrolling participants, so there are no results.
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 10 Jul 2013; AzTrials last refreshed its copy on 1 Nov 2026.