Multiple MyelomaPhase 2NCT00193544
Arsenic Trioxide and Thalidomide in the Treatment of Refractory Multiple Myeloma
A Phase 2 study testing Arsenic Trioxide and Thalidomide in people with Multiple Myeloma, run by SCRI Development Innovations, LLC.
Trial summary
In this trial, we plan to evaluate further the role of arsenic trioxide in the treatment of patients with refractory multiple myeloma. Arsenic trioxide will be used in combination with thalidomide. Although both drugs have a similar mechanism of action, it is likely that the mechanisms may be additive or synergistic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Arsenic Trioxide and Thalidomide
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Mar 2002to Jan 2009
- 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
Who may be able to join
- To be included in this study, you must meet the following criteria:
- Confirmed diagnosis of multiple Myeloma
- Received at least one previous chemotherapy regimen at most 3 previous
- Thalidomide with or without dexamethasone without chemotherapy will not factor in to total number of regimens.
- Age at least 18 years years
- Able to perform activities of daily living with minimal assistance
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- Life expectancy more than 3 months
- Adequate bone marrow, liver and kidney function
- Must give written informed consent in order to participate.
Who cannot join
- You cannot participate in this study if any of the following apply to you:
- Women pregnant or lactating.
- Pre-existing moderate neuropathy
- Patients with significant underlying cardiac dysfunction
- Uncontrolled hypercalcemia
- Active serious infections not controlled by antibiotics
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- History of grand mal seizures (other than infantile febrile seizures)
- Receiving other medications that prolong the QT interval.
- Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
About this study
Official title: Phase II Trial of Arsenic Trioxide and Thalidomide in the Treatment of Patients With Refractory Multiple Myeloma
In this trial, we plan to evaluate further the role of arsenic trioxide in the treatment of patients with refractory multiple myeloma. Arsenic trioxide will be used in combination with thalidomide. Although both drugs have a similar mechanism of action, it is likely that the mechanisms may be additive or synergistic. Since neither drug produces much myelosuppression, this combination regimen should be tolerable in patients with compromised marrow function due to involvement with myeloma and/or previous cytotoxic chemotherapy
Read the detailed description
Upon determination of eligibility, patients will be receive:
- Arsenic Trioxide + Thalidomide
- Conditions
- Multiple Myeloma
- Being tested
- Arsenic Trioxide, Thalidomide
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arsenic TrioxideDrug
ThalidomideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Secondary outcomes (3)
Overall survival
Time to progression
Overall toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startMar 2002
- Primary completionOct 2005
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- SCRI Development Innovations, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- CTI BioPharma
- Investigators
- John D. Hainsworth, MD, Principal investigator, SCRI Development Innovations, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00193544
- Sponsor's protocol ID
- SCRI MM 03
- Status last verified
- Jan 2009
- First submitted
- 12 Sep 2005
- Last updated
- 23 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Arsenic Trioxide and Thalidomide in the Treatment of Patients With Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00193544
- Acronym / sponsor ID
- SCRI MM 03
- Conditions
- Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- SCRI Development Innovations, LLCUniversity, hospital or other
- Collaborators
- CTI BioPharma
- Study start
- Mar 2002
- Primary completion
- Oct 2005 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 19 Sep 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.
In this trial, we plan to evaluate further the role of arsenic trioxide in the treatment of patients with refractory multiple myeloma. Arsenic trioxide will be used in combination with thalidomide. Although both drugs have a similar mechanism of action, it is likely that the mechanisms may be additive or synergistic. Since neither drug produces much myelosuppression, this combination regimen should be tolerable in patients with compromised marrow function due to involvement with myeloma and/or previous cytotoxic chemotherapy
Detailed description
Upon determination of eligibility, patients will be receive:
- Arsenic Trioxide + Thalidomide
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Confirmed diagnosis of multiple Myeloma
- Received at least one previous chemotherapy regimen at most 3 previous
- Thalidomide with or without dexamethasone without chemotherapy will not factor in to total number of regimens.
- Age at least 18 years years
- Able to perform activities of daily living with minimal assistance
Key exclusion criteria (9 listed)
- Women pregnant or lactating.
- Pre-existing moderate neuropathy
- Patients with significant underlying cardiac dysfunction
- Uncontrolled hypercalcemia
- Active serious infections not controlled by antibiotics
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 | – |
| Thalidomide | Drug | – |
Primary outcome
Overall response rate
3 secondary outcomes
Overall survival
Time to progression
Overall toxicity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2009.
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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.
John D. Hainsworth, MD principal investigator
SCRI Development Innovations, LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Arsenic Trioxide and Thalidomide in people with Multiple Myeloma, run by SCRI Development Innovations, LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. 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: finished, as of the sponsor's last update on 23 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Overall response rate. It is what the study was designed to measure, not a finding.
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 23 Jan 2009.