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NCT03984097Befejeződött1. fázis

A Study to Evaluate Subcutaneous TAK-079 Added to Standard of Care Regimens in Participants With Newly Diagnosed Multiple Myeloma (NDMM)

An Open-Label, Multicenter Phase 1b Study Investigating the Safety of TAK-079 in Combination With Backbone Regimens for the Treatment of Patients With Newly Diagnosed Multiple Myeloma and for Whom Stem Cell Transplantation Is Not Planned as Initial Therapy

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. ápr. 9.

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Rövid összefoglaló (regiszter, angolul)

The purpose of this original study is to determine the recommended phase 2 dose (RP2D) of TAK-079 when administered to participants with NDMM in combination with the backbone treatment regimen. The purpose of the safety/access cohort is to provide continued access to TAK-079 to participants previously enrolled to a TAK-079 parent study and to evaluate the long-term safety profile of TAK-079.

Állapot (regiszter)
Befejeződött
Fázis (regiszter)
1. fázis
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
50 (tényleges)
Első benyújtás
2019. jún. 11.
Kezdés
2019. júl. 29.
Elsődleges befejezés
2026. márc. 25.
Fő szponzor
Takeda
NCT-szám
NCT03984097

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó · 1. fázis
  • Bevont résztvevők: 50
  • 2019. júl. 29. és az elsődleges befejezés (2026. márc. 25.) között
  • 9 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

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  • Inclusion (Inc) Criteria:
  • Must have previously untreated multiple myeloma (MM) as defined by the IMWG criteria requiring treatment according to the investigator.
  • Are appropriate candidates for either the VRd or Rd backbone antimyeloma therapy according to the investigator.
  • Must have measurable disease defined by at least 1 of the following:
    • Serum M-protein >=1 gram per deciliter (g/dL) (>=10 gram/liter [g/L]).
    • Urine M-protein >=200 mg/24 hours.
    • Serum FLC assay: involved FLC level >=10 mg/dL (>=100 milligram per liter [mg/L]) provided the serum FLC ratio is abnormal.
  • Participants receiving lenalidomide must be able to take concurrent prophylactic anticoagulation per standard clinical practice as directed by the investigator.
  • Life expectancy >3 months.
  • Eastern Cooperative Oncology Group (ECOG) performance status score less than or equal to (<=) 2.
    • Inc Criteria for Participants in the Safety/Access Cohort (only):
    • Participants previously treated with TAK-079 therapy in a Takeda-sponsored TAK-079 parent study. Participants will be eligible to enter this cohort when:
  • The parent study is closed, planned to be closed, or has met its primary objectives.
    • Exclusion (Exc) Criteria:
  • Prior systemic therapy for MM.
    • o treatment with bisphosphonates or a single course of glucocorticoids does not disqualify the participant (the maximum dose of corticosteroids should not exceed the equivalent of 160 mg [for example, 40 milligram per day (mg/d) for 4 days] of dexamethasone).
  • Current participation in another interventional study, including other clinical trials with investigational agents (including investigational vaccines or investigational medical device) within 4 weeks of the first dose of TAK-079 or any agent in the backbone regimen and throughout the duration of this trial.
  • Prior radiation therapy within 14 days of the first dose of TAK-079 or any backbone regimen agents.
    • NOTE: Prophylactic localized ("spot") radiation for areas of pain is allowed.
  • Major surgery within 4 weeks before Cycle 1 Day 1 (kyphoplasty is not considered major surgery). Participants should be fully recovered from any surgically related complications.
  • Plasmapheresis within 28 days of randomization.
  • If plasmacytoma is the only measurable parameter for assessing disease response, participant is not eligible because of difficult response evaluation.
  • Clinical signs of meningeal involvement of MM exhibited during screening.
  • Serum positive for human immunodeficiency virus (HIV) or active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
  • Known severe allergic or anaphylactic reactions to human recombinant proteins or excipients used in the TAK-079 formulation or agents in the backbone regimen (lenalidomide, bortezomib, dexamethasone) as per the respective prescribing information or for TAK-079, as outlined in the current investigator's brochure (IB).
  • Systemic infection requiring systemic antibiotic therapy or other serious infection within 14 days before the first dose of TAK-079 or any agent in the backbone regimen. Urinary tract infection is not considered a systemic infection.
  • A 12-lead electrocardiogram (ECG) showing a QT interval corrected by Frederica's formula (QTcF) >470 milliseconds. If a machine reading is above this value, the ECG should be reviewed by a qualified reader and confirmed on a subsequent ECG.
  • Diagnosis of primary amyloidosis, Waldenstrom's disease, monoclonal gammopathy of undetermined significance (MGUS) or smoldering multiple myeloma (SMM) per IMWG criteria or standard diagnostic criteria, plasma cell leukemia (according to the World Health Organization [WHO] criterion: >=20% of cells in the peripheral blood with an absolute plasma cell count of more than 2 *10\^9/L), polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy and skin changes (POEMS syndrome), myelodysplastic syndrome, or myeloproliferative syndrome.
  • History of myelodysplastic syndrome or another malignancy other than MM, except for the following: any malignancy that has been in complete remission for 2 years, adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer (Gleason score <=6 without known metastatic disease and with no requirement for therapy, or requiring only hormonal therapy and stable prostate-specific antigen for >=1 year before initiation of study therapy), breast carcinoma in situ with full surgical resection, and treated medullary or papillary thyroid cancer.
    • Exc Criteria for Participants in the Safety/Access Cohort
  • Participants meeting any of the criteria for treatment discontinuation in the parent study.

Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (9)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
American Oncology Partners of Maryland, PABethesdaEgyesült ÁllamokIsmeretlen állapot
Alabama OncologyBirminghamEgyesült ÁllamokIsmeretlen állapot
Levine Cancer InstituteCharlotteEgyesült ÁllamokIsmeretlen állapot
Good Samaritan HospitalCincinnatiEgyesült ÁllamokIsmeretlen állapot
MD Anderson Cancer CenterHoustonEgyesült ÁllamokIsmeretlen állapot
Froedtert Hospital & the Medical College of WisconsinMilwaukeeEgyesült ÁllamokIsmeretlen állapot
Pacific Cancer CareMontereyEgyesült ÁllamokIsmeretlen állapot
Columbia University Medical CenterNew YorkEgyesült ÁllamokIsmeretlen állapot
Oregon Health Science UniversityPortlandEgyesült ÁllamokIsmeretlen állapot

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