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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00205751
First Posted: September 20, 2005
Last Update Posted: November 25, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Austrian Forum Against Cancer
  Purpose
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.

Condition Intervention Phase
Multiple Myeloma Drug: Thalidomide/Dexamethasone vs Melphalan/Prednisone Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Austrian Forum Against Cancer:

Primary Outcome Measures:
  • Time to progression
  • Response rate

Secondary Outcome Measures:
  • Survival
  • Time to response
  • Toxicity
  • Quality of life

Estimated Enrollment: 350
Study Start Date: August 2001
Study Completion Date: October 2009
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00205751


Locations
Austria
Wilhelminenspital, 1st Medical Department-center for oncology and hematology
Vienna, Austria, 1190
Sponsors and Collaborators
Austrian Forum Against Cancer
Investigators
Principal Investigator: Heinz Ludwig, MD,Univ.Prof Wilhelminenspital 1st medical dep.-center for oncology and hematology
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00205751     History of Changes
Other Study ID Numbers: 01-002-0601
First Submitted: September 12, 2005
First Posted: September 20, 2005
Last Update Posted: November 25, 2013
Last Verified: November 2013

Keywords provided by Austrian Forum Against Cancer:
Multiple Myeloma
first line treatment
thalidomide
melphalan

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Prednisone
Melphalan
Thalidomide
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal