Clinical trial · Interventional
S0232 Dexamethasone With or Without Lenalidomide in Treating Patients With Previously Untreated Stage I, Stage II, or Stage III Multiple Myeloma
Phase III Trial Comparing Dexamethasone (DEX) to the Combination of DEX + CC-5013 in Patients With Previously Untreated Multiple Myeloma
NCT00064038CI-TRIAL-00017248completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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 such as dexamethasone use different ways to stop cancer cells from dividing so they stop growing or die. Lenalidomide may stop the growth of multiple myeloma by stopping blood flow to the tumor. It is not yet known whether dexamethasone is more effective with or without lenalidomide in treating multiple myeloma. PURPOSE: This randomized phase III trial is studying dexamethasone and lenalidomide to see how well they work compared to dexamethasone alone in treating patients with previously untreated stage I, stage II, or stage III multiple myeloma.
Conditions
Conditions (2)
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 |
| Plasma Cell Neoplasm | Plasma Cell Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dexamethasone | Drug | Dexamethasone | ALIAS |
| lenalidomide | Drug | Lenalidomide | ALIAS |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: dexamethasone
- Drug: lenalidomide
- type
- ACTIVE_COMPARATOR
- label
- Arm II
- description
- Patients receive induction therapy comprising DM as in arm I induction and oral placebo on days 1-28. Treatment repeats as in arm I induction. Some patients may then receive maintenance therapy comprising oral DM as in arm I maintenance and oral placebo on days 1-21. Courses repeat as in arm I maintenance.
- interventionNames
- Drug: dexamethasone
- Other: placebo
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Previously untreated multiple myeloma * Stage I, II, or III disease by the International Staging System * Measurable M-protein as defined by 1 of the following: * Serum M-protein at least 1.0 g/dL by serum protein electrophoresis or immunoelectrophoresis * Urinary M-protein excretion at least 200 mg/24 hours * No nonsecretory multiple myeloma * Not planning to undergo future autologous stem cell transplantation PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Zubrod 0-3\* NOTE: \*Zubrod 3 allowed only if multiple myeloma is the central cause of disability Life expectancy * Not specified Hematopoietic * Platelet count at least 80,000/mm\^3\* * Absolute neutrophil count at least 1,000/mm\^3\* * Hemoglobin at least 9 g/dL\* (epoetin alfa or transfusion allowed) NOTE: \*Unless due to greater than 50% marrow involvement by myeloma on biopsy Hepatic * AST/ALT no greater than 3 times upper limit of normal\* NOTE: \*Values outside of this range are allowed at the investigator's discretion Renal * Creatinine no greater than 2.5 mg/dL\* NOTE: \*Values outside of this range are allowed at the investigator's discretion Cardiovascular * No New York Heart Association class III or IV heart failure * No myocardial infarction within the past 6 months * No poorly controlled hypertension Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception for 4 weeks before, during, and for 4 weeks after study treatment * Female patients must use 2 reliable forms of contraception simultaneously * Male patients must use effective barrier contraception * No uncontrolled active infection requiring IV antibiotics * No poorly controlled diabetes mellitus that would preclude ability to take oral glucocorticoids * No other serious medical condition that would preclude study participation * No psychiatric illness that would preclude study participation * No other malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * Must be able to take aspirin by mouth at a dose of 325 mg per day or enoxaparin subcutaneously at a dose of 40 mg per day as a form of thrombotic prophylaxis, except if already on therapeutic anticoagulant medication PRIOR CONCURRENT THERAPY: Biologic therapy * No prior interferon or thalidomide Chemotherapy * No prior chemotherapy Endocrine therapy * Prior high-dose dexamethasone allowed provided duration of administration was no more than 4 days Radiotherapy * Prior localized radiotherapy allowed provided it was not to the sole site of evaluable disease Surgery * Not specified Other * No prior treatment for clinically significant ventricular cardiac arrhythmias * Concurrent bisphosphonates allowed
References
Publications (3)
- RESULTZonder JA, Crowley JJ, Bolejack V, et al.: A randomized Southwest Oncology Group study comparing dexamethasone (D) to lenalidomide + dexamethasone (LD) as treatment of newly-diagnosed multiple myeloma (NDMM): impact of cytogenetic abnormalities on efficacy of LD, and updated overall study results. [Abstract] J Clin Oncol 26 (Suppl 15): A-8521, 2008.
- RESULTZonder JA, Crowley J, Hussein MA, et al.: Superiority of lenalidomide (Len) plus high-dose dexamethasone (HD) compared to HD alone as treatment of newly-diagnosed multiple myeloma (NDMM): results of the randomized, double-blinded, placebo-controlled SWOG trial S0232. [Abstract] Blood 110 (11): A-77, 2007.
- DERIVEDZonder JA, Crowley J, Hussein MA, Bolejack V, Moore DF Sr, Whittenberger BF, Abidi MH, Durie BG, Barlogie B. Lenalidomide and high-dose dexamethasone compared with dexamethasone as initial therapy for multiple myeloma: a randomized Southwest Oncology Group trial (S0232). Blood. 2010 Dec 23;116(26):5838-41. doi: 10.1182/blood-2010-08-303487. Epub 2010 Sep 27. PMID 20876454