Clinical trial · Interventional
Lenalidomide and Vaccine Therapy in Treating Patients With Relapsed or Refractory Multiple Myeloma
Revlimid to Augment Efficacy of Prevnar Vaccines in Patients With Relapsed or Refractory Myeloma
NCT00445484CI-TRIAL-00018920completedPhase 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: Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Vaccines may help the body build an effective immune response to kill cancer cells. Giving lenalidomide together with vaccine therapy may make a stronger immune response and kill more cancer cells. PURPOSE: This phase II trial is studying how well giving lenalidomide together with vaccine therapy works in treating patients with relapsed 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lenalidomide | Drug | Lenalidomide | ALIAS |
| pneumococcal polyvalent vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group 1
- description
- Patients receive oral lenalidomide on days 1-21. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Patients receive pneumococcal polyvalent vaccine intramuscularly (IM) 14 days prior to beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).
- interventionNames
- Biological: pneumococcal polyvalent vaccine
- Drug: lenalidomide
- type
- EXPERIMENTAL
- label
- Group 2
- description
- Patients receive lenalidomide as in group 1. Patients receive pneumococcal polyvalent vaccine IM approximately 45 days after beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).
- interventionNames
- Biological: pneumococcal polyvalent vaccine
- Drug: lenalidomide
Primary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of multiple myeloma (MM) meeting all of the following criteria: * Relapsed or refractory disease * Previously received ≥ 2 courses of antimyeloma treatment * Measurable levels of myeloma paraprotein in serum (\> 0.5 g/dL) or urine (\> 0.2 g/24-hour urine collection) OR serum-free light-chain disease PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Absolute neutrophil count ≥ 1,000/mm\^3 * Platelet count ≥ 75,000/mm\^3 * Creatinine ≤ 2.5 mg/dL * Bilirubin ≤ 2.0 mg/dL * AST and ALT ≤ 3 times upper limit of normal * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use 2 methods of highly effective contraception ≥ 4 weeks before, during, and for 4 weeks after completion of study therapy * No other malignancy within the past 5 years except treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast * No serious medical condition, laboratory abnormality, or psychiatric illness that would preclude study treatment or put patient at unacceptable risk * No known hypersensitivity to thalidomide or lenalidomide * No development of erythema nodosum in the presence of a reaction characterized by a desquamating rash while taking thalidomide or similar drugs * No known hypersensitivity to any component of the pneumococcal polyvalent vaccine, including diphtheria toxin or CRM 197 * No known HIV positivity * No infectious hepatitis type A, B, or C PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No more than 3 prior treatment regimens for MM * More than 6 months since prior lenalidomide * More than 28 days since prior experimental drug or therapy * More than 1 month since prior systemic antimyeloma therapy * More than 1 month since prior and no concurrent systemic corticosteroids * No other concurrent anticancer agents or treatments or investigational agents * No concurrent thalidomide * No concurrent radiotherapy * No other concurrent immune therapy or immunomodulatory agents
References
Publications (1)
- RESULTNoonan K, Rudraraju L, Ferguson A, Emerling A, Pasetti MF, Huff CA, Borrello I. Lenalidomide-induced immunomodulation in multiple myeloma: impact on vaccines and antitumor responses. Clin Cancer Res. 2012 Mar 1;18(5):1426-34. doi: 10.1158/1078-0432.CCR-11-1221. Epub 2012 Jan 12. PMID 22241792