BT062 in Combination With Lenalidomide or Pomalidomide and Dexamethasone in Patients With Multiple Myeloma
NCT ID: NCT01638936
Last Updated: 2019-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
64 participants
INTERVENTIONAL
2012-07-03
2018-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BT062
BT062 administered intravenously on days 1, 8 and 15 of each 28-day cycle, and lenalidomide or pomalidomide and dexamethasone administered orally to subjects with relapsed or relapsed/refractory MM
BT062 , intravenous administration
Dose escalation to determine dose limiting toxicities (DLTs) and/or the maximum tolerated dose (MTD)/recommended Phase II dose (RPTD) of BT062 in combination with lenalidomide/dexamethasone
Interventions
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BT062 , intravenous administration
Dose escalation to determine dose limiting toxicities (DLTs) and/or the maximum tolerated dose (MTD)/recommended Phase II dose (RPTD) of BT062 in combination with lenalidomide/dexamethasone
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Relapsed or relapsed/refractory progressive Multiple Myeloma
* Subjects who failed at least one prior therapy (BT062/Len/dex)
* Subjects who failed at least two prior therapy (BT062/Pom/dex)
* Subjects age ≥18 years
* Life expectancy of ≥12 weeks
* Eastern Cooperative Oncology Group (ECOG) performance status (Zubrod) ≤2
* Normal organ and bone marrow
* Signed written informed consent in accordance with federal, local, and institutional guidelines
* Subjects must agree to follow all Guidelines from REVLIMID REMS Program or POMALYST REMS
* Women of child bearing potential (WCBP), must agree to use 2 contraceptive methods
Exclusion Criteria
* Antineoplastic therapy with biological agents within 2 weeks before day 1 or within 5 drug half-lives (t½) prior to first dose, whichever time period is longer
* Concomitant antineoplastic therapies including chemotherapy, radiotherapy, or biological agents during the study
* Treatment with another investigational drug during the study or within 3 weeks before day 1 or within 5 drug half-live (t½) prior to first dose, whichever time period is longer
* Treatment with BT062 in previous studies
* Major surgery within 4 weeks before day 1 (this does not include placement of vascular access device or tumor biopsies)
* Malignancy within 3 years before day 1, other than the trial indication multiple myeloma and excluding treated non-melanoma skin cancer, superficial bladder cancer, carcinoma in-situ of the cervix and prostate carcinoma ≤ Gleason Grade 6 with stable prostate specific antigen (PSA) levels
* Subjects with plasma cell leukemia (PCL)
* Subjects with deep vein thrombosis (DVT) and Pulmonary embolism (PE) within 3 months prior to day 1 treatment
* Severe infections necessitating use of antibiotics / antivirals during the screening period
* Clinically relevant active infection including active hepatitis B or C or human immunodeficiency virus (HBV, HCV, or HIV) or any other concurrent disease
* Acute or relevant abnormalities in electrocardiogram (ECG)
* Significant cardiac disease
* Pregnant or breast-feeding
* Positive serum or urine pregnancy test
* Hypersensitivity to the active substance or to any of the excipients for study drug BT062, or history of severe allergic or anaphylactic reaction to therapeutic proteins (e.g. reaction to vaccination or to biological therapy)
18 Years
ALL
No
Sponsors
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Biotest
INDUSTRY
Biotest Pharmaceuticals Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Kenneth C Anderson, MD
Role: STUDY_DIRECTOR
Dana-Farber Cancer Institute
Locations
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City of Hope
Duarte, California, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Mayo Clinic
Jacksonville, Florida, United States
Memorial Healthcare System
Pembroke Pines, Florida, United States
Emory University Winship Cancer Institute
Atlanta, Georgia, United States
The University of Chicago
Chicago, Illinois, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Mount Sinai Medical Center
New York, New York, United States
University of Texas Health Science Center
San Antonio, Texas, United States
Countries
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References
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Kelly KR, Ailawadhi S, Siegel DS, Heffner LT, Somlo G, Jagannath S, Zimmerman TM, Munshi NC, Madan S, Chanan-Khan A, Lonial S, Chandwani S, Minasyan A, Ruehle M, Barmaki-Rad F, Abdolzade-Bavil A, Rharbaoui F, Herrmann-Keiner E, Haeder T, Wartenberg-Demand A, Anderson KC. Indatuximab ravtansine plus dexamethasone with lenalidomide or pomalidomide in relapsed or refractory multiple myeloma: a multicentre, phase 1/2a study. Lancet Haematol. 2021 Nov;8(11):e794-e807. doi: 10.1016/S2352-3026(21)00208-8. Epub 2021 Sep 13.
Other Identifiers
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983
Identifier Type: -
Identifier Source: org_study_id
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