Clinical trial · Interventional
Lenalidomide With or Without Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma
A Phase II Trial of Revlimid® and "On Demand" Dexamethasone Dosing in Patients With Newly Diagnosed Symptomatic Multiple Myeloma
NCT00772915CI-TRIAL-00042863completedPhase 2Results 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: Lenalidomide and dexamethasone may stop the growth of multiple myeloma by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well lenalidomide works with or without dexamethasone in treating patients with newly diagnosed 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dexamethasone | Drug | Dexamethasone | ALIAS |
| lenalidomide | Drug | Lenalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lenalidomide with On-Demand Dexamethasone
- description
- Lenalidmoide: 25mg once daily orally with food on days 1-21 of 28 day cycle until progression or to a maximum of 18 cycles. Dexamethasone: 10-40 mg once weekly (days 1, 8, 15, \& 22) orally with food until progression.
- interventionNames
- Drug: dexamethasone
- Drug: lenalidomide
Primary outcomes (1)
- measure
- Progression-free Survival (PFS) Rate at 12 Months
- timeFrame
- 12 months from registration
- description
- PFS rate at 12 months is defined as the percentage of participants who are alive and progression-free at 12 months. Progression is exclusively defined as a patient with progressive disease while receiving treatment with lenalidomide in combination with dexamethasone. Progression was defined as any one or more of the following: An increase of 25% from lowest confirmed response in: * Serum M-component (absolute increase \>= 0.5g/dl) * Urine M-component (absolute increase \>= 200mg/24hour * Difference between involved and uninvolved Free Light Chain levels (absolute increase \>= 10mg/dl * Bone marrow plasma cell percentage (absolute increase of \>=10%)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Newly diagnosed multiple myeloma, meeting the following criteria: * Symptomatic disease * Previously untreated disease * Measurable or evaluable disease, defined by ≥ 1 of the following: * Serum monoclonal protein ≥ 1.0 g/dL * Monoclonal protein \> 200 mg by 24-hour urine electrophoresis * Serum immunoglobulin free light chain ≥ 10 mg/dL AND abnormal serum immunoglobulin kappa:lambda free light chain ratio * Monoclonal bone marrow plasmacytosis ≥ 30% (evaluable disease) * Measurable soft tissue plasmacytoma, not previously radiated * No monoclonal gammopathy of unknown significance or asymptomatic myeloma PATIENT CHARACTERISTICS: * ECOG performance status (PS) 0-2 (PS 3 allowed if secondary to pain) * ANC ≥ 1,500/μL * Platelet count ≥ 75,000/μL * Creatinine ≤ 2.0 mg/dL * Total bilirubin ≤ 1.5 mg/dL * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use 2 effective forms of contraception 28 days prior to, during and 28 days after study treatment * Registered into the RevAssist® program and willing to comply with program requirements * Able to take prophylactic aspirin (325 mg/day) or warfarin or low molecular weight heparin * Willing to provide mandatory blood and bone marrow samples * Willing to return for follow up * No uncontrolled infection * No NYHA class III or IV heart failure * No active deep vein thrombosis that has not been therapeutically anticoagulated * No known hypersensitivity to thalidomide * No known HIV positivity * No known hepatitis type A, B, or C infection * No other prior active malignancy within the past 2 years, except currently treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast * No development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs PRIOR CONCURRENT THERAPY: * At least 3 weeks since prior radiotherapy for solitary plasmacytoma * More than 28 days since other prior experimental drug or therapy * Prior clarithromycin, DHEA, anakinra, pamidronate, or zoledronic acid allowed * No prior lenalidomide * No prior cytotoxic chemotherapy * No prior corticosteroids (≥ 160 mg of dexamethasone or equivalent) for this disease * Prior corticosteroid for nonmalignant disease allowed * Concurrent corticosteroids allowed (≤ 20 mg/day of prednisone or equivalent) * Concurrent palliative radiotherapy for bone pain or fracture allowed * No other concurrent anticancer agents or treatments
References
Publications (0)
Data not yet available
No reference posted for this study.