Clinical trial · Interventional
Thalidomide/Dexamethasone vs MP for Induction Therapy and Thalidomide/Intron A vs Intron A for Maintenance Therapy
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Thalidomide/Dexamethasone vs Melphalan/Prednisone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Time to progression
- measure
- Response rate
Secondary outcomes (4)
- measure
- Survival
- measure
- Time to response
- measure
- Toxicity
- measure
- Quality of life
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDLudwig 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 20418244
- DERIVEDLudwig 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 18955563