Clinical trial · Interventional
Dexamethasone With or Without Thalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma
A Randomized Phase III Trial Of Thalidomide (NSC # 66847) Plus Dexamethasone Versus Dexamethasone In Newly Diagnosed 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)
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining dexamethasone and thalidomide may kill more cancer cells. It is not yet known whether dexamethasone is more effective with or without thalidomide in treating multiple myeloma. PURPOSE: Randomized phase III trial to determine the effectiveness of dexamethasone with or without thalidomide in treating patients who have multiple myeloma.
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 and Plasma Cell Neoplasm | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dexamethasone | Drug | Dexamethasone | ALIAS |
| pamidronate disodium | Drug | — | UNRESOLVED |
| thalidomide | Drug | Thalidomide | ALIAS |
| zoledronic acid | Drug | Zoledronic Acid | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Newly diagnosed symptomatic multiple myeloma confirmed by the following: * Bone marrow plasmacytosis with at least 10% plasma cells or sheets of plasma cells or biopsy-proven plasmacytosis * Monoclonal protein (M protein) at least 1.0 g/dL on serum protein electrophoresis or at least 200 mg of monoclonal light chain on a 24-hour urine protein electrophoresis * No smoldering myeloma or monoclonal gammopathy of undetermined significance PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count greater than 1,000/mm\^3 * Platelet count greater than 50,000/mm\^3 * Hemoglobin greater than 7 g/dL Hepatic: * Bilirubin no greater than 1.5 mg/dL * ALT and AST no greater than 2.5 times upper limit of normal Renal: * Creatinine less than 3 mg/dL Cardiovascular: * No prior or concurrent deep venous thrombosis Other: * Prior malignancy allowed provided the following criteria are met: * Received prior treatment with curative intent * Free of disease for the time period appropriate for cure of the specific cancer * No grade 2 or greater peripheral neuropathy due to other medical conditions * No active infection * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use 1 highly effective method and 1 additional method of contraception for 1 month before, during, and for 4 weeks after study for women and effective barrier contraception for men during and for 4 weeks after study participation PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior biologic therapy for multiple myeloma * No other concurrent biologic therapy for multiple myeloma Chemotherapy: * No prior chemotherapy for multiple myeloma * No other concurrent chemotherapy for multiple myeloma Endocrine therapy: * More than 6 months since prior systemic dexamethasone or glucocorticoids * No concurrent corticosteroids Radiotherapy: * At least 4 weeks since prior palliative, localized radiotherapy * Concurrent palliative, localized radiotherapy allowed at the physician's discretion Surgery: * Not specified Other: * No prior systemic therapy for multiple myeloma, except bisphosphonates * No concurrent anticoagulant therapy for deep vein thrombosis * No concurrent barbiturates or alcohol (thalidomide arm)
References
Publications (5)
- BACKGROUNDBallester O. The emperor's new clothes or the current practice of clinical trials for multiple myeloma in the USA. Cancer Invest. 2008 Jun;26(5):445-7. doi: 10.1080/07357900701874641. PMID 18568765
- BACKGROUNDJohnson DC, Corthals S, Ramos C, Hoering A, Cocks K, Dickens NJ, Haessler J, Goldschmidt H, Child JA, Bell SE, Jackson G, Baris D, Rajkumar SV, Davies FE, Durie BG, Crowley J, Sonneveld P, Van Ness B, Morgan GJ. Genetic associations with thalidomide mediated venous thrombotic events in myeloma identified using targeted genotyping. Blood. 2008 Dec 15;112(13):4924-34. doi: 10.1182/blood-2008-02-140434. Epub 2008 Sep 19. PMID 18805967
- RESULTKumar S, Greipp PR, Haug JL, et al.: Correlation of bone marrow angiogenesis and response to thalidomide dexamethasone in multiple myeloma. [Abstract] J Clin Oncol 24 (Suppl 18): A-7621, 451s, 2006.
- RESULTRajkumar SV, Blood E, Vesole D, Fonseca R, Greipp PR; Eastern Cooperative Oncology Group. Phase III clinical trial of thalidomide plus dexamethasone compared with dexamethasone alone in newly diagnosed multiple myeloma: a clinical trial coordinated by the Eastern Cooperative Oncology Group. J Clin Oncol. 2006 Jan 20;24(3):431-6. doi: 10.1200/JCO.2005.03.0221. Epub 2005 Dec 19. PMID 16365178
- RESULTGreipp PR. Eastern Cooperative Oncology Group E1A00: phase III randomized study of dexamethasone with or without thalidomide in patients with newly diagnosed multiple myeloma. Clin Adv Hematol Oncol. 2003 Mar;1(3):188-9. No abstract available. PMID 16224404