Multiple MyelomaPhase 2NCT00124813
Thalidomide, Cyclophosphamide, Oral Idarubicin and Dexamethasone (T-CID) in Patients With Multiple Myeloma
A Phase 2 study testing thalidomide and idarubicin in people with Multiple Myeloma, run by University Hospital, Bonn at 1 site in Germany.
Trial summary
Background: In some studies, thalidomide in combination with chemotherapy has been shown to be effective in patients with relapsed or refractory multiple myeloma (MM). In this study, the researchers have chosen a regimen which can be administered on an outpatient basis. 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?
- thalidomide and idarubicin
- Type of treatment
- Pill or oral medicine
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2002to Nov 2010
- 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
- Patients with multiple myeloma according to British Columbia Cancer Agency Criteria
- Stage IIA/B or IIIA/B according to Durie/Salmon
- Symptomatic or progressive disease
- Status of disease:
- refractory disease after standard induction therapy
- OR relapse after standard induction therapy
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- OR relapse after high-dose chemotherapy/stem cell transplantation
- OR patients with plasma cell leukemia
- Patients with measurable paraprotein in urine or serum or quantifiable bone marrow infiltration
- Written informed consent
Who cannot join
- Age < 18 years
- Life expectancy of less than 3 months
- Intolerance to the study drugs
- No change or progressive disease after prior therapy with idarubicin or cyclophosphamide
- Cardiac insufficiency New York Heart Association (NYHA) grade 3 or 4
- Acute infection
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- Actually decompensated diabetes mellitus
- Total bilirubin > 3.0 mg/dl
- Pregnant or breast-feeding women
- Polyneuropathy grade 2 or higher
- Ulcus ventriculi or duodeni
- Narrow or open angle glaucoma
- Not-compensated psychiatric diseases
- Prior erythroblastopenia
- Prior therapy with investigational drugs within the last 4 weeks
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Medical Clinic & Policlinic III, University of Bonn
Bonn, 53105
Ingo Schmidt-Wolf, MD, +49-228-287-15507, picasso@uni-bonn.de
Ingo Schmidt-Wolf, MD
About this study
Official title: Thalidomide, Cyclophosphamide, Oral Idarubicin and Dexamethasone (T-CID) as Induction Therapy and a Randomized Trial of Thalidomide vs Thalidomide Plus Oral Idarubicin as Maintenance Therapy in Patients With Multiple Myeloma
Background: In some studies, thalidomide in combination with chemotherapy has been shown to be effective in patients with relapsed or refractory multiple myeloma (MM). In this study, the researchers have chosen a regimen which can be administered on an outpatient basis.
Induction therapy: To evaluate the efficacy and toxicity of thalidomide, cyclophosphamide, oral idarubicin and dexamethasone (T-CID) in patients with relapsed or refractory multiple myeloma.
Maintenance therapy: Randomized trial to compare efficacy and toxicity of thalidomide and thalidomide plus oral idarubicin as maintenance therapy in patients with at least stable disease after T-CID.
Read the detailed description
Background: In some studies, thalidomide in combination with chemotherapy has been shown to be effective in patients with relapsed or refractory multiple myeloma (MM). In this study, the researchers have chosen a regimen which can be administered on an outpatient basis.
After 3-8 cycles of T-CID patients with at least stable disease will be randomized to receive thalidomide or thalidomide plus oral idarubicin as maintenance therapy for at least one year or until progression.
- Conditions
- Multiple Myeloma
- Being tested
- thalidomide, idarubicin
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thalidomideDrug
idarubicinDrug
oral idarubicin
What is being measured
The primary outcome is the main question the study is designed to answer.
Induction therapy: response rate, overall survival, death rate
Maintenance therapy: progression-free survival, overall survival, number of patients discontinuing therapy due to toxicity
Secondary outcomes (2)
Induction therapy: number of patients discontinuing therapy due to toxicity, number of patients experiencing toxicity grade 3 or 4
Maintenance therapy: dose intensity, number of patients experiencing toxicity grade 3 or 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2005 (estimated)
- Study startAug 2002
- Primary completionMay 2010 (estimated)
- Study completionNov 2010 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Investigators
- Ingo Schmidt-Wolf, MD, Principal investigator, University of Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00124813
- Sponsor's protocol ID
- T-CID
- Status last verified
- Feb 2010
- First submitted
- 27 Jul 2005
- Last updated
- 2 Feb 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thalidomide, Cyclophosphamide, Oral Idarubicin and Dexamethasone (T-CID) as Induction Therapy and a Randomized Trial of Thalidomide vs Thalidomide Plus Oral Idarubicin as Maintenance Therapy in Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00124813
- Acronym / sponsor ID
- T-CID
- Conditions
- Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- Aug 2002
- Primary completion
- May 2010 (estimated)
- Study completion
- Nov 2010 (estimated)
- First posted
- 28 Jul 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.
Background: In some studies, thalidomide in combination with chemotherapy has been shown to be effective in patients with relapsed or refractory multiple myeloma (MM). In this study, the researchers have chosen a regimen which can be administered on an outpatient basis.
Induction therapy: To evaluate the efficacy and toxicity of thalidomide, cyclophosphamide, oral idarubicin and dexamethasone (T-CID) in patients with relapsed or refractory multiple myeloma.
Maintenance therapy: Randomized trial to compare efficacy and toxicity of thalidomide and thalidomide plus oral idarubicin as maintenance therapy in patients with at least stable disease after T-CID.
Detailed description
Background: In some studies, thalidomide in combination with chemotherapy has been shown to be effective in patients with relapsed or refractory multiple myeloma (MM). In this study, the researchers have chosen a regimen which can be administered on an outpatient basis.
After 3-8 cycles of T-CID patients with at least stable disease will be randomized to receive thalidomide or thalidomide plus oral idarubicin as maintenance therapy for at least one year or until progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 (10 listed)
- Patients with multiple myeloma according to British Columbia Cancer Agency Criteria
- Stage IIA/B or IIIA/B according to Durie/Salmon
- Symptomatic or progressive disease
- Status of disease:
- Patients with measurable paraprotein in urine or serum or quantifiable bone marrow infiltration
Key exclusion criteria (15 listed)
- Age < 18 years
- Life expectancy of less than 3 months
- Intolerance to the study drugs
- No change or progressive disease after prior therapy with idarubicin or cyclophosphamide
- Cardiac insufficiency New York Heart Association (NYHA) grade 3 or 4
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 |
|---|---|---|
| thalidomide | Drug | – |
| idarubicinoral idarubicin | Drug | – |
Primary outcome
Induction therapy: response rate, overall survival, death rate
Maintenance therapy: progression-free survival, overall survival, number of patients discontinuing therapy due to toxicity
2 secondary outcomes
Induction therapy: number of patients discontinuing therapy due to toxicity, number of patients experiencing toxicity grade 3 or 4
Maintenance therapy: dose intensity, number of patients experiencing toxicity grade 3 or 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2010.
- Related InfoLink provided by the sponsor.
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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.
Ingo Schmidt-Wolf, MD principal investigator
University of Bonn
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 thalidomide and idarubicin in people with Multiple Myeloma, run by University Hospital, Bonn at 1 site in Germany.
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 10 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 2 Feb 2010. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Axel Glasmacher, MD (+49-228-287-15507, glasmacher@uni-bonn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Induction therapy: response rate, overall survival, death rate. The study lists 2 primary outcomes in all. 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 2 Feb 2010.