Clinical trial · Interventional
Lenalidomide and Rituximab in Treating Patients With Recurrent and/or Refractory Multiple Myeloma
Phase II Study of Lenalidomide and Rituximab for Patients With Relapsed and/or Refractory CD20+ Multiple Myeloma
NCT00567229CI-TRIAL-00019898terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of Accrual
Summary
Brief summary (as posted)
RATIONALE: Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving lenalidomide together with rituximab may be an effective treatment for multiple myeloma. PURPOSE: This phase II trial is studying the side effects of giving lenalidomide together with rituximab and to see how well it works in treating patients with recurrent or refractory 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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| flow cytometry | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| lenalidomide | Drug | Lenalidomide | ALIAS |
| microarray analysis | Genetic | — | UNRESOLVED |
| rituximab | Biological | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lenalidomide and Rituximab
- description
- This study will employ a Simon optimal two-stage design. Patients will receive lenalidomide 25 mg daily for days 1-21 of each 28 day cycle. Rituximab 375 mg/m2 will be given weekly for 4 weeks beginning 1 week after the start of lenalidomide therapy (weeks 2-5), and then once 8 weeks later (week 13). Patients with stable disease or better after 4 cycles (week 16, in the absence of delays for toxicity) will be able to continue on therapy on the same lenalidomide schedule and with rituximab 375 mg/m2 given once every 8 weeks.
- interventionNames
- Biological: rituximab
- Drug: lenalidomide
- Genetic: microarray analysis
- Other: flow cytometry
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Final Response Rate After 4 Courses of Treatment
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed CD20+ multiple myeloma
* CD20+ disease defined as co-expression of CD20 on ≥ 25% of the clonal plasma cell population as defined by immunohistochemical or flow cytometric staining of a bone marrow or plasmacytoma specimen obtained at study entry
* For flow cytometry, this is determined by calculating the frequency of CD20+ CD138+ double-positive cells within the total CD138+ plasma cell population
* For immunohistochemistry, this is determined by dual staining for CD20 and the involved clonal light chain (kappa or lambda), with a determination of the percent double-positive (≤ 25% or ≥ 25%)
* Symptomatic multiple myeloma that has relapsed or progressed after at least 1 prior anti-myeloma therapeutic regimen
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Life expectancy \> 16 weeks (4 months)
* ANC ≥ 1,500/μL (unless low ANC due to multiple myeloma)
* Platelets ≥ 100,000/μL (unless low platelets are due to multiple myeloma)
* Serum bilirubin ≤ 2.0 mg/dL
* AST, ALT, and alkaline phosphatase \< 3 times upper limit of normal
* Serum creatinine ≤ 2.5 mg/dL
* Able to understand the investigational nature of lenalidomide and rituximab combination therapy and to give informed consent
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective double-method contraception at least 28 days before, during, and for at least 28 days after completion or discontinuation of study treatment
* Able to take acetylsalicylic acid (ASA) (325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin)
* Prior malignancies with a disease free interval of ≥ 5 years allowed
* No history of thromboembolic disease within the past 6 months, regardless of anticoagulation
* No myocardial infarction within the past 6 months
* No New York Hospital Association class III or IV heart failure
* No uncontrolled angina
* No severe uncontrolled ventricular arrhythmias
* No active hepatitis B or C infection
* No HIV 1or 2 positivity
* No acute ischemia or active conduction system abnormalities as evidenced by ECG
* No history of hypersensitivity reactions to lenalidomide, thalidomide, or rituximab
* No other medical condition or laboratory evaluation that, in the treating physician's or principal investigators' opinion, makes the patient unsuitable to participate in this clinical trial
* No concurrent active malignancy other than nonmelanoma skin cancers or carcinoma-in-situ of the cervix
PRIOR CONCURRENT THERAPY:
* At least 3 weeks since prior therapy, including radiotherapy
* Prior lenalidomide or thalidomide allowed
* No prior rituximabReferences
Publications (0)
Data not yet available
No reference posted for this study.