Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III, Phase II Treatment Active 19 and over Other 01-002-0601 NCT00205751

Trial Description

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.

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Austrian Forum Against Cancer

Heinz Ludwig, MD,Univ.Prof

Principal Investigator

Heinz Ludwig, MD,Univ.Prof		Ph: +43-1-49150 Ext.2101
		Email: heinz.ludwig@wienkav.at

Elisabeth M Kueenburg, MD		Ph: +43-1-49150 Ext.2162
		Email: elisabeth.kueenburg@wienkav.at

Austria
	Vienna
	Wilhelminenspital der Stadt Wien
		Heinz Ludwig, MD,Univ.Prof	Ph: +43-1-49150 Ext.2101
			Email: heinz.ludwig@wienkav.at
		Elisabeth M Kueenburg, MD	Ph: +43-1-49150 Ext.2162
			Email: elisabeth.kueenburg@wienkav.at
		Heinz Ludwig, MD,Univ.Prof	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00205751
Information obtained from ClinicalTrials.gov on May 27, 2008