- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00445484
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
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
OBJECTIVES:
Primary
- Determine whether lenalidomide can augment the efficacy of pneumococcal polyvalent vaccine as it correlates with lenalidomide-induced antitumor efficacy in patients with relapsed or refractory multiple myeloma.
Secondary
- Determine the antibody responses to pneumococcal serotypes in patients treated with this regimen.
- Determine T-cell responses to the carrier protein CRM 197 in patients treated with this regimen.
- Determine the ability of lenalidomide to augment in vivo immune responsiveness as measured by cutaneous delayed-type hypersensitivity (DTH) reactions to Candida and tetanus in these patients.
- Determine the ability of lenalidomide to prime and/or boost systemic vaccine responses in both peripheral blood lymphocytes and marrow lymphocytes in these patients.
OUTLINE: Patients are assigned to 1 of 2 treatment groups.
- Group 1: 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).
- Group 2: 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).
After completion of study treatment, patients are followed at 30 days.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Maryland
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Baltimore, Maryland, Stati Uniti, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Group 1
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).
|
Dato oralmente
Dato per via intramuscolare
|
|
Sperimentale: Group 2
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).
|
Dato oralmente
Dato per via intramuscolare
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
6B Antibody Response to Prevnar Vaccine in Peripheral Blood
Lasso di tempo: basline and 8 weeks after second vaccination
|
Serum IgG levels against the PVC serotype were measured by ELISA
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basline and 8 weeks after second vaccination
|
|
14F Antibody Response to Prevnar Vaccine in Peripheral Blood
Lasso di tempo: basline and 8 weeks after second vaccination
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Serum IgG levels against the PVC serotype were measured by ELISA
|
basline and 8 weeks after second vaccination
|
|
19F Antibody Response to Prevnar Vaccine in Peripheral Blood
Lasso di tempo: basline and 8 weeks after second vaccination
|
Serum IgG levels against the PVC serotype were measured by ELISA
|
basline and 8 weeks after second vaccination
|
|
23F Antibody Response to Prevnar Vaccine in Peripheral Blood
Lasso di tempo: basline and 8 weeks after second vaccination
|
Serum IgG levels against the PVC serotype were measured by ELISA
|
basline and 8 weeks after second vaccination
|
Collaboratori e investigatori
Collaboratori
Investigatori
- Cattedra di studio: Ivan Borrello, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattia cardiovascolare
- Malattie vascolari
- Malattie del sistema immunitario
- Neoplasie per tipo istologico
- Neoplasie
- Malattie linfoproliferative
- Disturbi immunoproliferativi
- Malattie ematologiche
- Disturbi emorragici
- Disturbi emostatici
- Paraproteinemie
- Disturbi delle proteine del sangue
- Mieloma multiplo
- Neoplasie, plasmacellule
- Plasmocitoma
- Effetti fisiologici delle droghe
- Agenti antineoplastici
- Fattori immunologici
- Inibitori dell'angiogenesi
- Agenti di modulazione dell'angiogenesi
- Sostanze per la crescita
- Inibitori della crescita
- Vaccino coniugato pneumococcico eptavalente
- Lenalidomide
Altri numeri di identificazione dello studio
- J06102 CDR0000532944
- P30CA006973 (Sovvenzione/contratto NIH degli Stati Uniti)
- JHOC-J06102
- JHOC-NA_00006008
- CELGENE-CC-5013
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su lenalidomide
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Arbeitsgemeinschaft medikamentoese TumortherapieCelgene CorporationSconosciutoLeucemia Mielomonocitica CronicaAustria
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University Hopsital Schleswig Holstein Campus LübeckReclutamentoMieloma multiplo di nuova diagnosiGermania