Back to resultsMaintenance Therapy After Thalidomide-Dexamethasone(ThaDD) for Multiple Myeloma(MM)
Primary Purpose
Multiple Myeloma
Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
thalidomide
interferon alpha
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring thalidomide, maintenance, interferon, dexamethasone, newly diagnosed multiple myeloma, relapsed refractory multiple myeloma
Eligibility Criteria
Inclusion Criteria:
- patients with newly diagnosed or advanced multiple myeloma achieving at least a minimal response after induction with ThaDD regimen
- Written consent
Exclusion Criteria:
- peripheral neuropathy >= grade 2
- neutropenia < 1000/mcl or thrombocytopenia < 50000/mcl
- severe depression
- organ disfunction > grade 2
Sites / Locations
- Clinica di ematologia ospedali riuniti ancona università politecnica delle marche
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TD
ID
Arm Description
thalidomide-dexamethasone
Interferon-dexamethasone
Outcomes
Primary Outcome Measures
progression free survival
Secondary Outcome Measures
overall survival safety
Full Information
NCT ID
NCT00633542
First Posted
January 2, 2008
Last Updated
March 4, 2008
Sponsor
Università Politecnica delle Marche
1. Study Identification
Unique Protocol Identification Number
NCT00633542
Brief Title
Maintenance Therapy After Thalidomide-Dexamethasone(ThaDD) for Multiple Myeloma(MM)
Official Title
Thalidomide-Dexamethasone vs Alpha-Interferon-Dexamethasone as Maintenance Therapy After Thalidomide, Dexamethasone and Pegylated Liposomal Doxorubicin Combination for
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Università Politecnica delle Marche
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
thalidomide, maintenance, interferon, dexamethasone, newly diagnosed multiple myeloma, relapsed refractory multiple myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
103 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TD
Arm Type
Experimental
Arm Description
thalidomide-dexamethasone
Arm Title
ID
Arm Type
Active Comparator
Arm Description
Interferon-dexamethasone
Intervention Type
Drug
Intervention Name(s)
thalidomide
Intervention Description
100 mg/day orally until progression or severe toxicity
Intervention Type
Drug
Intervention Name(s)
interferon alpha
Intervention Description
3 MU 3 times a week until progression or severe toxicity
Primary Outcome Measure Information:
Title
progression free survival
Time Frame
3 years
Secondary Outcome Measure Information:
Title
overall survival safety
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with newly diagnosed or advanced multiple myeloma achieving at least a minimal response after induction with ThaDD regimen
Written consent
Exclusion Criteria:
peripheral neuropathy >= grade 2
neutropenia < 1000/mcl or thrombocytopenia < 50000/mcl
severe depression
organ disfunction > grade 2
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Offidani Massimo, MD
Organizational Affiliation
clinica di ematologia ospedali riuniti ancona università politecnica delle marche
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pietro Leoni, MD, PhD
Organizational Affiliation
clinica di ematologia università politecnica delle marche
Official's Role
Study Chair
Facility Information:
Facility Name
Clinica di ematologia ospedali riuniti ancona università politecnica delle marche
City
Ancona
ZIP/Postal Code
60020
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
16763209
Citation
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.
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Maintenance Therapy After Thalidomide-Dexamethasone(ThaDD) for Multiple Myeloma(MM)
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