Multiple MyelomaPhase 3NCT00633542
Maintenance Therapy After Thalidomide-Dexamethasone(ThaDD) for Multiple Myeloma(MM)
A Phase 3 study testing thalidomide and interferon alpha in people with Multiple Myeloma, run by Università Politecnica delle Marche at 1 site in Italy.
Trial summary
This is randomized, multicentre study aimed to compare a standard maintenance therapy with Interferon-Dexamethasone with an experimental therapy based on Thalidomide-Dexamethasone in patients with multiple myeloma who responded to ThaDD induction therapy 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 interferon alpha
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2003to Oct 2007
- Phase
- Phase 3
- 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 newly diagnosed or advanced multiple myeloma achieving at least a minimal response after induction with ThaDD regimen
- Written consent
Who cannot join
- peripheral neuropathy >= grade 2
- neutropenia < 1000/mcl or thrombocytopenia < 50000/mcl
- severe depression
- organ disfunction > grade 2
Trial locations and contacts
1 site in 1 country.
Italy1 site
Clinica di ematologia ospedali riuniti ancona università politecnica delle marche
Ancona, 60020
About this study
Official title: Thalidomide-Dexamethasone vs Alpha-Interferon-Dexamethasone as Maintenance Therapy After Thalidomide, Dexamethasone and Pegylated Liposomal Doxorubicin Combination for
This is randomized, multicentre study aimed to compare a standard maintenance therapy with Interferon-Dexamethasone with an experimental therapy based on Thalidomide-Dexamethasone in patients with multiple myeloma who responded to ThaDD induction therapy
Read the detailed description
Thalidomide has already been used as maintenance and/or consolidation after high-dose therapy followed by autologous stem cell transplantation. Despite a number of phase II and III studies the issues of right dose and duration of thalidomide and subsets of patients benefiting from it have not yet been settled We explored the maintenance therapy after thalidomide, dexamethasone and pegylated liposomal doxorubicin called ThaDD protocol. Patients with de novo or relapsed MM obtaining at least minor response after 4 to 6 ThaDD courses, were randomized to receive standard maintenance therapy with IFN 3 MU 3 times a week or an experimental maintenance therapy such as thalidomide 100 mg per day until relapse or intolerable side effects. Both groups also received pulsed dexamethasone 20 mg 4 days a month.
- Conditions
- Multiple Myeloma
- Being tested
- thalidomide, interferon alpha
- Keywords
- thalidomide, maintenance, interferon, dexamethasone, newly diagnosed multiple myeloma, relapsed refractory multiple myeloma
- 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
100 mg/day orally until progression or severe toxicity
interferon alphaDrug
3 MU 3 times a week until progression or severe toxicity
| Study group | Role | What they receive |
|---|---|---|
| TD | Experimental | thalidomide-dexamethasone Receives: Drug: thalidomide |
| ID | Active comparator | Interferon-dexamethasone Receives: Drug: interferon alpha |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
Measured: 3 years
Secondary outcomes (1)
overall survival safety
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2008 (estimated)
- Study startJun 2003
- Primary completionSep 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università Politecnica delle Marche
- Sponsor type
- University, hospital or other
- Investigators
- Offidani Massimo, MD, Principal investigator, clinica di ematologia ospedali riuniti ancona università politecnica delle marchePietro Leoni, MD, PhD, Study chair, clinica di ematologia università politecnica delle marche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00633542
- Sponsor's protocol ID
- MO 02/02 MM
- Other IDs
- AIL 2002
- Status last verified
- Mar 2008
- First submitted
- 2 Jan 2008
- Last updated
- 12 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Offidani M, Corvatta L, Piersantelli MN, Visani G, Alesiani F, Brunori M, Galieni P, Catarini M, Burattini M, Centurioni R, Ferranti M, Rupoli S, Scortechini AR, Giuliodori L, Candela M, Capelli D, Montanari M, Olivieri A, Poloni A, Polloni C, Marconi M, Leoni P. Thalidomide, dexamethasone, and pegylated liposomal doxorubicin (ThaDD) for patients older than 65 years with newly diagnosed multiple myeloma. Blood. 2006 Oct 1;108(7):2159-64. doi: 10.1182/blood-2006-03-013086. Epub 2006 Jun 8.
PubMed 16763209
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thalidomide-Dexamethasone vs Alpha-Interferon-Dexamethasone as Maintenance Therapy After Thalidomide, Dexamethasone and Pegylated Liposomal Doxorubicin Combination for
- ClinicalTrials.gov ID
- NCT00633542
- Acronym / sponsor ID
- MO 02/02 MM
- Conditions
- Multiple Myeloma
- Keywords
- thalidomide, maintenance, interferon, dexamethasone, newly diagnosed multiple myeloma, relapsed refractory multiple myeloma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Università Politecnica delle MarcheUniversity, hospital or other
- Study start
- Jun 2003
- Primary completion
- Sep 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 12 Mar 2008 (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.
This is randomized, multicentre study aimed to compare a standard maintenance therapy with Interferon-Dexamethasone with an experimental therapy based on Thalidomide-Dexamethasone in patients with multiple myeloma who responded to ThaDD induction therapy
Detailed description
Thalidomide has already been used as maintenance and/or consolidation after high-dose therapy followed by autologous stem cell transplantation. Despite a number of phase II and III studies the issues of right dose and duration of thalidomide and subsets of patients benefiting from it have not yet been settled We explored the maintenance therapy after thalidomide, dexamethasone and pegylated liposomal doxorubicin called ThaDD protocol. Patients with de novo or relapsed MM obtaining at least minor response after 4 to 6 ThaDD courses, were randomized to receive standard maintenance therapy with IFN 3 MU 3 times a week or an experimental maintenance therapy such as thalidomide 100 mg per day until relapse or intolerable side effects. Both groups also received pulsed dexamethasone 20 mg 4 days a month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TD | Experimental | Drug: thalidomidethalidomide-dexamethasone |
| ID | Active comparator | Drug: interferon alphaInterferon-dexamethasone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients with newly diagnosed or advanced multiple myeloma achieving at least a minimal response after induction with ThaDD regimen
- Written consent
Key exclusion criteria (4 listed)
- peripheral neuropathy >= grade 2
- neutropenia < 1000/mcl or thrombocytopenia < 50000/mcl
- severe depression
- organ disfunction > grade 2
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 |
|---|---|---|
| thalidomide100 mg/day orally until progression or severe toxicity | Drug | TD |
| interferon alpha3 MU 3 times a week until progression or severe toxicity | Drug | ID |
Primary outcome
progression free survival
Time frame: 3 years
1 secondary outcome
overall survival safety
Time frame: 3 years
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 12 Mar 2008.
- Background: PubMed 16763209Offidani M, Corvatta L, Piersantelli MN, Visani G, Alesiani F, Brunori M, Galieni P, Catarini M, Burattini M, Centurioni R, Ferranti M, Rupoli S, Scortechini AR, Giuliodori L, Candela M, Capelli D, Montanari M, Olivieri A, Poloni A, Polloni C, Marconi M, Leoni P. Thalidomide, dexamethasone, and pegylated liposomal doxorubicin (ThaDD) for patients older than 65 years with newly diagnosed multiple myeloma. Blood. 2006 Oct 1;108(7):2159-64. doi: 10.1182/blood-2006-03-013086. Epub 2006 Jun 8.
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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.
Offidani Massimo, MD principal investigator
clinica di ematologia ospedali riuniti ancona università politecnica delle marche
Pietro Leoni, MD, PhD study chair
clinica di ematologia università politecnica delle marche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing thalidomide and interferon alpha in people with Multiple Myeloma, run by Università Politecnica delle Marche at 1 site in Italy.
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 2 inclusion and 4 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 12 Mar 2008. 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 Italy. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
progression free survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00633542, which also lists 1 linked publication.
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 12 Mar 2008.