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CompletedNCT00205751Updated Nov 25, 2013

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

A Phase 2/3 interventional study of Thalidomide/Dexamethasone vs Melphalan/Prednisone in Multiple Myeloma, sponsored by Austrian Forum Against Cancer. Completed at 1 site in Austria. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2013-11-25.

Sponsored by Austrian Forum Against Cancer · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
350
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Multiple Myeloma

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Keywords

  • Multiple Myeloma
  • first line treatment
  • thalidomide
  • melphalan
03

In context

Multiple Myeloma

3,712 studies on the registry are indexed under Multiple Myeloma; 752 are open to participants now.

This study's planned enrollment of 350 is above the median of 41 across 2,965 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Austrian Forum Against Cancer is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
350 participants (estimated)

Interventions

  • DrugThalidomide/Dexamethasone vs Melphalan/Prednisone
06

What researchers measure

Primary outcomes

  1. Time to progression

  2. Response rate

Secondary outcomes

  1. Survival

  2. Time to response

  3. Toxicity

  4. Quality of life

07

Study locations

1 site
  • Wilhelminenspital, 1st Medical Department-center for oncology and hematology
    Vienna, 1190, Austria
08

References and documents

Publications

  • 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. PubMed 20418244 ↗
  • 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. PubMed 18955563 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2001 and a completion of Oct 2009. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 12, 2005
First posted
Sep 20, 2005
Start
Aug 2001
CompletionActual
Oct 2009
Last update
Nov 25, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 25, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00205751
Lead sponsor
Austrian Forum Against Cancer
First posted
Sep 20, 2005
Start date
Aug 2001
Completion
Oct 2009
Last update
Nov 25, 2013

Study contacts

Heinz Ludwig, MD,Univ.Prof
principal investigator · Wilhelminenspital 1st medical dep.-center for oncology and hematology
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.

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Discussion

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