- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT05052970
Mitoxantrone Hydrochloride Liposome Injection, Bortezomib and Dexamethasone in the Treatment of R/R MM
16 januari 2022 uppdaterad av: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
A Phase Ⅰ Clinical Study of Mitoxantrone Hydrochloride Liposome Injection in Combination With Bortezomib and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
The purpose of this study is to evaluate the safety and efficacy of mitoxantrone hydrochloride liposome injection in combination with bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma.
Studieöversikt
Status
Rekrytering
Betingelser
Detaljerad beskrivning
This is a multicenter, open-label, phase I study aimed to evaluate the safety and efficacy of mitoxantrone hydrochloride liposome injection in combination with bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma.
In the study, 60 patients will be recruited into three dose groups.
All patients will receive the treatment for the planned 8 cycles(28 days per cycle)until disease progression or unacceptable drug-related adverse events
Studietyp
Interventionell
Inskrivning (Förväntat)
60
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Na An
- Telefonnummer: +86-010-63930582
- E-post: anna@mail.ecspc.com
Studieorter
-
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Beijing
-
Beijing, Beijing, Kina
- Rekrytering
- Beijing Chaoyang Hospital, Capital Medical University
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Kontakt:
- Wenming Chen, Doctor
- Telefonnummer: 13910107759
- E-post: 13910107759@163.com
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 75 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Patients fully understand and voluntarily participate in this study and sign informed consent;
- Aged 18-75 years, without gender limitation;
- Patients with relapsed or refractory multiple myeloma(confirmed by histologically or cytologically) who had received at least one prior line regular treatment;
- Patients have at least one of the following conditions:(1)Serum M protein≥10g/L;(2)Urine M protein≥200 mg/24h; (3)Serum free light chain(sFLC): κ/λ FLC ratio is abnormal and affected FLC ≥100mg /L
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2;
Laboratory tests meet the following conditions:
- Absolute neutrophil count (ANC) ≥1.5x10^9/L (No G-CSF treatment within 1 week prior to the laboratory test);
- Platelet count ≥ 75x10^9/L (No platelet transfusion within 1 week prior to the laboratory test);
- Total bilirubin ≤1.5upper limit of normal (ULN);
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 ULN;
- Creatinine clearance(Ccr) ≥30mL/min.
- Females of childbearing potential must have a negative serum beta human chorionic gonadotrophin (β-hCG) pregnancy test result prior to enrollment and must agree to use an effective contraception method for the duration of the study treatment and 7 months after the last dose of study therapy.
Males patients and their partners must agree to use an effective contraceptive method for the duration of the study treatment and 4 months after the last dose of study therapy.
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Exclusion Criteria:
- Patients with amyloidosis or central nervous system invasion or on dialysis treatment.
- Life expectancy < 3 months.
- History of allergy to mitoxantrone hydrochloride or liposomes;or previous treatment with adriamycin or other anthracyclines, with the total cumulative dose (doxorubicin equivalent) ≥350 mg/m^2.
- History of allergy (except local injection reaction) or intolerance to bortezomib;or one of the following conditions occurred with prior bortezomib regimens: no treatment response (not reach MR),disease progression within 6 months after the end of last dose.
- History of contraindications or intolerance to dexamethasone.
- Any anti-myeloma drug treatment or radiotherapy within 4 weeks prior to the first dose; or enrolled in any other clinical trials of anti-myeloma drug within 3 months prior to the first dose.
- History of autologous hematopoietic stem cell transplantation within 6 months prior to screening.
- History of allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
- Adverse events from the previous treatment have not resolved to ≤ Grade 1 (except for alopecia, hyperpigmentation).
- Patients with persistent Grade≥2 peripheral neuropathy or Grade 1 peripheral neuropathy with pain.
- Patients with impaired cardiac function or significant cardiac disease.
- HBsAg/HBcAb positive with HBV-DNA titer higher than the lower limit of the test value of the research center, or HCV antibody positive with HCV-RNA titer higher than the lower limit of the test value of the research center,or human immunodeficiency virus (HIV) antibody positive.
- Patients with obvious digestive system dysfunction, which may affect intake, transport and absorption of the study drug.
- Active bacterial, fungal or viral infections that require systemic treatment within 1 week prior to the first dose
- Patients underwent major surgery within 6 weeks prior to the first dose, or had a surgical schedule during the study period;
- History of additional malignant tumor within 5 years, except for locally curable cancer that has been cured.
- Other medical conditions that, in the judgment of the investigator, may affect the patient's participation in this study.
- Pregnant or breastfeeding women;
Not suitable for this study as decided by the investigator due to other reasons.
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Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 12 mg/m ^ 2 dose group (ArmA)
Patients with relapsed or refractory multiple myeloma will receive mitoxantrone hydrochloride liposome in combination with bortezomib and dexamethasone for 8 cycles (planned) (28 days per cycle).
The dose of mitoxantrone hydrochloride liposome is 12 mg/m^2
|
Mitoxantrone Hydrochloride Liposome injection will be administered by an intravenous infusion on day 1 of each 28-day cycle
Andra namn:
Bortezomib (1.3 mg/m^2) will be administered by an intravenous injection or subcutaneously on day 1,4,8,11of each 28-day cycle
Andra namn:
Dexamethasone (20 mg/d) will be taken orally on day 1,2,4,5,8,9,11,12 of each 28-day cycle
Andra namn:
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Experimentell: 16 mg/m ^ 2 dose group (ArmB)
Patients with relapsed or refractory multiple myeloma will receive mitoxantrone hydrochloride liposome in combination with bortezomib and dexamethasone for 8 cycles (planned) (28 days per cycle).
The dose of mitoxantrone hydrochloride liposome is 16 mg/m^2
|
Mitoxantrone Hydrochloride Liposome injection will be administered by an intravenous infusion on day 1 of each 28-day cycle
Andra namn:
Bortezomib (1.3 mg/m^2) will be administered by an intravenous injection or subcutaneously on day 1,4,8,11of each 28-day cycle
Andra namn:
Dexamethasone (20 mg/d) will be taken orally on day 1,2,4,5,8,9,11,12 of each 28-day cycle
Andra namn:
|
Experimentell: 20 mg/m ^ 2 dose group (ArmC)
Patients with relapsed or refractory multiple myeloma will receive mitoxantrone hydrochloride liposome in combination with bortezomib and dexamethasone for 8 cycles (planned) (28 days per cycle).
The dose of mitoxantrone hydrochloride liposome is 20 mg/m^2
|
Mitoxantrone Hydrochloride Liposome injection will be administered by an intravenous infusion on day 1 of each 28-day cycle
Andra namn:
Bortezomib (1.3 mg/m^2) will be administered by an intravenous injection or subcutaneously on day 1,4,8,11of each 28-day cycle
Andra namn:
Dexamethasone (20 mg/d) will be taken orally on day 1,2,4,5,8,9,11,12 of each 28-day cycle
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Treatment-emergent adverse events (TEAEs)
Tidsram: From the initiation of the first dose to 28 days after the last dose
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To indentify the incidence of TEAEs
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From the initiation of the first dose to 28 days after the last dose
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Objective response rate (ORR)
Tidsram: Throughout the study treatment(Up to 32 weeks)
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ORR is defined as the proportion of patients who have a best overall response of partial response (PR),very good partial response(VGPR), complete response (CR) or stringent complete response (sCR) as per International Myeloma Working Group (IMWG)
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Throughout the study treatment(Up to 32 weeks)
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Clinical Benefit Rate(CBR)
Tidsram: Throughout the study treatment(Up to 32 weeks)
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CBR is defined as the proportion of patients who have a best overall response of minimal response(MR),PR,VGPR,CR or sCR as per IMWG
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Throughout the study treatment(Up to 32 weeks)
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Disease control rate(DCR)
Tidsram: Throughout the study treatment(Up to 32 weeks)
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DCR is defined as the proportion of patients who have a best overall response of stable disease (SD),MR,PR,VGPR,CR or sCR as per IMWG
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Throughout the study treatment(Up to 32 weeks)
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Duration of response (DoR)
Tidsram: Throughout the study completion.(An average of 12 months)
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DoR is defined as the time from the first assessment of PR,VGPR,CR orsCR until the date of first occurrence of progressive disease (PD) as per IMWG
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Throughout the study completion.(An average of 12 months)
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Progression-free survival (PFS)
Tidsram: Throughout the study completion.(An average of 12 months)
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PFS is defined as the time from the date of first dose until the date of first documented PD as per IMWG or death from any cause, whichever occurs first
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Throughout the study completion.(An average of 12 months)
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Overall survival (OS)
Tidsram: Throughout the study completion.(An average of 36 months)
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OS is defined as the time from the date of first dose until the date of death from any cause
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Throughout the study completion.(An average of 36 months)
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Wenming Chen, Beijing Chaoyang Hospital affiliated to Capital Medical University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
20 oktober 2021
Primärt slutförande (Förväntat)
20 april 2023
Avslutad studie (Förväntat)
20 juni 2024
Studieregistreringsdatum
Först inskickad
13 september 2021
Först inskickad som uppfyllde QC-kriterierna
13 september 2021
Första postat (Faktisk)
22 september 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
1 februari 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
16 januari 2022
Senast verifierad
1 januari 2022
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Hjärt-kärlsjukdomar
- Kärlsjukdomar
- Immunsystemets sjukdomar
- Neoplasmer efter histologisk typ
- Neoplasmer
- Lymfoproliferativa störningar
- Immunproliferativa störningar
- Hematologiska sjukdomar
- Hemorragiska störningar
- Hemostatiska störningar
- Paraproteinemier
- Blodproteinstörningar
- Multipelt myelom
- Neoplasmer, Plasmacell
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Autonoma agenter
- Agenter från det perifera nervsystemet
- Enzyminhibitorer
- Analgetika
- Sensoriska systemagenter
- Antiinflammatoriska medel
- Antineoplastiska medel
- Antiemetika
- Gastrointestinala medel
- Glukokortikoider
- Hormoner
- Hormoner, hormonsubstitut och hormonantagonister
- Antineoplastiska medel, hormonella
- Proteashämmare
- Topoisomeras II-hämmare
- Topoisomerasinhibitorer
- Dexametason
- Dexametasonacetat
- BB 1101
- Bortezomib
- Mitoxantron
Andra studie-ID-nummer
- HE071-CSP-023
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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Second Affiliated Hospital, School of Medicine,...Ningbo No. 1 Hospital; Jinhua Central Hospital; Huizhou Municipal Central...Rekrytering
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Second Affiliated Hospital of Soochow UniversityThe Affiliated Hospital of Xuzhou Medical UniversityRekryteringÅterfall/refraktärt multipelt myelomKina
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