NCT00205751

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for phase_2 multiple-myeloma

Timeline
Completed

Started Aug 2001

Longer than P75 for phase_2 multiple-myeloma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2001

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

November 25, 2013

Status Verified

November 1, 2013

First QC Date

September 12, 2005

Last Update Submit

November 21, 2013

Conditions

Multiple Myeloma

Keywords

Multiple Myelomafirst line treatmentthalidomidemelphalan

Outcome Measures

Primary Outcomes (2)

  • Time to progression

  • Response rate

Secondary Outcomes (4)

  • Survival

  • Time to response

  • Toxicity

  • Quality of life

Interventions

Thalidomide/Dexamethasone vs Melphalan/PrednisoneDRUG

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Vienna, 1190, Austria

Location

Related Publications (2)

  • 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.

    PMID: 20418244DERIVED

  • 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.

    PMID: 18955563DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Heinz Ludwig, MD,Univ.Prof

    Wilhelminenspital 1st medical dep.-center for oncology and hematology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

August 1, 2001

Study Completion

October 1, 2009

Last Updated

November 25, 2013

Record last verified: 2013-11

Locations

AU(1)