- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01212952
Pomalidomide, Bortezomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma
MC1082: A Phase I/II Trial of Pomalidomide (CC-4047), Bortezomib, and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose (MTD) of bortezomib in combination with pomalidomide and dexamethasone.
II. To evaluate the hematologic response rate (PR, VGPR, or CR) of pomalidomide, bortezomib and dexamethasone in patients with relapsed or refractory myeloma.
SECONDARY OBJECTIVES:
I. Time to progression.
II. To assess the toxicity of pomalidomide, bortezomib and dexamethasone in this patient population.
OUTLINE : This is a phase I, dose-escalation study of bortezomib followed by a phase II study. Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8,15, 22; and oral dexamethasone on days 1, 8, 15, 22 . Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
- Fase 1
Contatti e Sedi
Luoghi di studio
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Arizona
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Scottsdale, Arizona, Stati Uniti
- Mayo Clinic in Arizona
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Florida
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Jacksonville, Florida, Stati Uniti
- Mayo Clinic in Florida
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Minnesota
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Rochester, Minnesota, Stati Uniti, 55905
- Mayo Clinic
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Serum Creatinine =< 3 mg/dL
- Absolute neutrophil count >= 1000/uL
- Platelet count >= 75,000/uL
Measurable disease of multiple myeloma as defined by at least ONE of the following:
- serum monoclonal protein >= 1.0 g/dL
- > 200 mg of monoclonal protein in the urine on 24 hour electrophoresis
- serum immunoglobulin free light chain >= 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
- monoclonal bone marrow plasmacytosis >= 30% (evaluable disease)
- measurable plasmacytoma that has not been radiated
- ECOG Performance status (PS) 0, 1, or 2
- Previously treated relapsed or refractory multiple myeloma
Patients must have received at least one prior therapy but no more than 4 therapies.
- one or more of the prior regimens must have included lenalidomide and it has been determined the patient is refractory, resistant, or relapsed this therapy
- prior bortezomib not required but if prior exposure, patients should not be refractory (Refractory means progression on therapy or within 60 days from the last dose of bortezomib.)
- Provide informed written consent
- Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of starting pomalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking pomalidomide; FCBP must also agree to ongoing pregnancy testing
- Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a vasectomy
- All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure
- Willing and able to take aspirin or alternate prophylactic anticoagulation
- All previous cancer therapy, including chemotherapy, high dose corticosteroids, immune modulatory drugs or proteosome inhibitors must have been discontinued >= 2 weeks prior to study registration
- Any prior treatment with investigational agents must be discontinued >= 28 days prior to study registration
- Willing to abstain from donating blood during study participation and for 28 days after discontinuation of study drug
- Men must agree to abstain from donating semen or sperm during study participation and for 28 days after discontinuation of study drug
- Willingness to return to enrolling institution for follow-up
Exclusion Criteria:
- Concomitant high dose corticosteroids (concurrent use of corticosteroids); EXCEPTION: Patients may be on chronic steroids (maximum dose 20 mg/day prednisone equivalent) if they are being given for disorders other than myeloma, i.e., adrenal insufficiency, rheumatoid arthritis, etc
- Another malignancy undergoing active treatment with the exception of non melanoma skin cancer or in situ cervical or breast cancer
- Pregnant women or women of reproductive ability who are unwilling to use effective contraception
- Nursing women
- Men who are unwilling to use a condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking the drug and for 4 weeks after stopping treatment
- Other co-morbidity which would interfere with patient's ability to participate in trial, e.g. uncontrolled infection, uncompensated heart or lung disease
- Other concurrent chemotherapy, radiotherapy, or any ancillary therapy considered investigational: NOTE: Bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment
- Active DVT or PE that has not been therapeutically anticoagulated
- Known positive for HIV or active hepatitis infection
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
- Known hypersensitivity to thalidomide or lenalidomide including development of erythema nodosum if characterized by a desquamating rash
- > grade 2 peripheral neuropathy
- Any prior use of pomalidomide
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Arm I
Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses.
Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
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Dato oralmente
Altri nomi:
Studi correlativi facoltativi
Dato IV
Altri nomi:
Dato oralmente
Altri nomi:
Optional correlative studies
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Find Maximum Tolerated Dose (MTD) of Bortezomib in Combination With Pomalidomide and Dexamethasone Out to 2.5 Years, by Count of Patients With Dose Limiting Toxicities.
Lasso di tempo: 2.5 years
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MTD is defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients).
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2.5 years
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Number of Participants With a Hematologic Response (PR, VGPR, or CR)
Lasso di tempo: 2.5 years
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The number of participants who achieve PR, VGPR, or CR as defined by The International Myeloma Working Group uniform response criteria(2011).
sCR: CR as defined below plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.
CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow.
VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or > 90% reduction in serum M-protein plus urine M-protein level < 100 mg/24 h.
PR: > 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by >90% or to < 200 mg/24 h.
MR: NA.
SD: Not meeting criteria for CR, VGPR, PR, or progressive disease.
PD: Increase of > 25% from lowest response value in any one or more of the following: Serum M-component and/or (the absolute increase must be > 0.5 g/dL), Urine M-component and/or (the absolute increase must be > 200 mg/24 h)
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2.5 years
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Progression Free Survival
Lasso di tempo: 2.5 years
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The progression-free survival (PFS) time is defined as the time from registration to progression or death due to any cause.
The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.
PD: Increase of > 25% from lowest response value in any one or more of the following: Serum M-component and/or (the absolute increase must be > 0.5 g/dL), Urine M-component and/or (the absolute increase must be > 200 mg/24 h)
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2.5 years
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Number of Participants With Adverse Events
Lasso di tempo: 2.5 years
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Reported in Adverse Events section of the results
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2.5 years
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Cattedra di studio: Martha Lacy, M.D., Mayo Clinic
- Investigatore principale: Joseph R. Mikhael, M.D., Mayo Clinic
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
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 (Effettivo)
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
- Effetti fisiologici delle droghe
- Agenti autonomi
- Agenti del sistema nervoso periferico
- Agenti antinfiammatori
- Agenti antineoplastici
- Fattori immunologici
- Antiemetici
- Agenti gastrointestinali
- Glucocorticoidi
- Ormoni
- Ormoni, sostituti ormonali e antagonisti ormonali
- Agenti antineoplastici, ormonali
- Inibitori dell'angiogenesi
- Agenti di modulazione dell'angiogenesi
- Sostanze per la crescita
- Inibitori della crescita
- Desametasone
- Pomalidomide
- Bortezomib
Altri numeri di identificazione dello studio
- MC1082 (Altro identificatore: Mayo Clinic Cancer Center)
- NCI-2010-01967 (Identificatore di registro: NCI's CTRO)
- 10-001545 (Altro identificatore: Mayo Clinic IRB)
- PO-MM-PI-0019 (Altro identificatore: Celgene Protocol)
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 desametasone
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