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Thalidomide/Dexamethasone vs MP for Induction Therapy and Thalidomide/Intron A vs Intron A for Maintenance Therapy

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 2
Locations
Austria
Study Type
Interventional
Intervention
Thalidomide/Dexamethasone vs Melphalan/Prednisone
Sponsored by
Austrian Forum Against Cancer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, first line treatment, thalidomide, melphalan

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with Multiple Myeloma of IgG, IgA, IgD, IgE, IgM lambda or kappa light chain, low secretory or non-secretory disease WHO performance status 0,1,2,or 3 No prior treatment of multiple myeloma Clear requirement of treatment (usually Durie/Salmon stage II or III) Anticipated life expectancy of at least 3 months Adequate organ function Minimum recovery period of 2 weeks following any major surgical procedure before entry into this study Women, who are sterilized via hysterectomy or bilateral tubal ligation or at least one year post-menopausal Age of at least 19 years, there is no upper age limit patients must have been informed and must have signed an informed consent Exclusion Criteria: Extramedullary plasmocytoma or solitary plasmocytoma without evidence of dissemination of disease Benign monoclonal gammopathy Multiple myeloma of IgM without osteolytic bone lesions Smouldering myeloma More than 3 irradiation fields Irreversible performance status of WHO4 Prior treatment of myeloma with any of the following: chemotherapeutic or immunomodulatory agents, corticosteroids, antiangiogenic agents or other investigational drugs Women of childbearing potential Preexisting peripheral polyneuropathy Congestive heart failure NYHA III, IV Acute infection requiring systemic antibiotics at study entry until resolved Any uncontrolled underlying medical condition (eg diabetes, glaucoma) Second primary malignancy (with the exception of cervical carcinoma in situ and non-myeloma skin malignancies) unless patient has been disease-free for at least three years

Sites / Locations

  • Wilhelminenspital, 1st Medical Department-center for oncology and hematology

Outcomes

Primary Outcome Measures

Time to progression
Response rate

Secondary Outcome Measures

Survival
Time to response
Toxicity
Quality of life

Full Information

First Posted
September 12, 2005
Last Updated
November 21, 2013
Sponsor
Austrian Forum Against Cancer
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1. Study Identification

Unique Protocol Identification Number
NCT00205751
Brief Title
Thalidomide/Dexamethasone vs MP for Induction Therapy and Thalidomide/Intron A vs Intron A for Maintenance Therapy
Official Title
International, Multi-center, Prospective, Double Randomized, Open Phase III Study Evaluating Thalidomide/Dexamethasone Versus Melphalan/Prednisone as Induction Therapy and Thalidomide/Interferon-alpha Versus Interferon-alpha as Maintenance Therapy in Newly Diagnosed Patients With Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Austrian Forum Against Cancer

4. Oversight

5. Study Description

Brief Summary
This is an international multi-center prospective, double randomized, open, controlled phase III study with a phase II entrance phase to compare the therapeutic efficacy of thalidomide plus dexamethasone to conventional melphalan plus prednisone in newly diagnosed myeloma patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma, first line treatment, thalidomide, melphalan

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Thalidomide/Dexamethasone vs Melphalan/Prednisone
Primary Outcome Measure Information:
Title
Time to progression
Title
Response rate
Secondary Outcome Measure Information:
Title
Survival
Title
Time to response
Title
Toxicity
Title
Quality of life

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with Multiple Myeloma of IgG, IgA, IgD, IgE, IgM lambda or kappa light chain, low secretory or non-secretory disease WHO performance status 0,1,2,or 3 No prior treatment of multiple myeloma Clear requirement of treatment (usually Durie/Salmon stage II or III) Anticipated life expectancy of at least 3 months Adequate organ function Minimum recovery period of 2 weeks following any major surgical procedure before entry into this study Women, who are sterilized via hysterectomy or bilateral tubal ligation or at least one year post-menopausal Age of at least 19 years, there is no upper age limit patients must have been informed and must have signed an informed consent Exclusion Criteria: Extramedullary plasmocytoma or solitary plasmocytoma without evidence of dissemination of disease Benign monoclonal gammopathy Multiple myeloma of IgM without osteolytic bone lesions Smouldering myeloma More than 3 irradiation fields Irreversible performance status of WHO4 Prior treatment of myeloma with any of the following: chemotherapeutic or immunomodulatory agents, corticosteroids, antiangiogenic agents or other investigational drugs Women of childbearing potential Preexisting peripheral polyneuropathy Congestive heart failure NYHA III, IV Acute infection requiring systemic antibiotics at study entry until resolved Any uncontrolled underlying medical condition (eg diabetes, glaucoma) Second primary malignancy (with the exception of cervical carcinoma in situ and non-myeloma skin malignancies) unless patient has been disease-free for at least three years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heinz Ludwig, MD,Univ.Prof
Organizational Affiliation
Wilhelminenspital 1st medical dep.-center for oncology and hematology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wilhelminenspital, 1st Medical Department-center for oncology and hematology
City
Vienna
ZIP/Postal Code
1190
Country
Austria

12. IPD Sharing Statement

Citations:
PubMed Identifier
20418244
Citation
Ludwig H, Adam Z, Tothova E, Hajek R, Labar B, Egyed M, Spicka I, Gisslinger H, Drach J, Kuhn I, Hinke A, Zojer N. Thalidomide maintenance treatment increases progression-free but not overall survival in elderly patients with myeloma. Haematologica. 2010 Sep;95(9):1548-54. doi: 10.3324/haematol.2009.020586. Epub 2010 Apr 23.
Results Reference
derived
PubMed Identifier
18955563
Citation
Ludwig H, Hajek R, Tothova E, Drach J, Adam Z, Labar B, Egyed M, Spicka I, Gisslinger H, Greil R, Kuhn I, Zojer N, Hinke A. Thalidomide-dexamethasone compared with melphalan-prednisolone in elderly patients with multiple myeloma. Blood. 2009 Apr 9;113(15):3435-42. doi: 10.1182/blood-2008-07-169565. Epub 2008 Oct 27.
Results Reference
derived

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Thalidomide/Dexamethasone vs MP for Induction Therapy and Thalidomide/Intron A vs Intron A for Maintenance Therapy

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