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BT062 in Combination With Lenalidomide or Pomalidomide and Dexamethasone in Patients With Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01638936
Recruitment Status : Completed
First Posted : July 12, 2012
Last Update Posted : July 23, 2019
Sponsor:
Collaborator:
Biotest
Information provided by (Responsible Party):
Biotest Pharmaceuticals Corporation

Tracking Information
First Submitted Date  ICMJE March 8, 2012
First Posted Date  ICMJE July 12, 2012
Last Update Posted Date July 23, 2019
Actual Study Start Date  ICMJE July 3, 2012
Actual Primary Completion Date October 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2016)
  • Determination of optimal dose of BT062 (Phase I part) [ Time Frame: 6 months ]
    The Phase I part will follow a standard dose escalation design with at least 3 patients per dose level to define optimal dose of BT062 in combination with lenalidomide/dexamethasone. Optimal dose will be defined by dose limiting toxicities (DLT) observed during Cycle 1 (28 days).
  • Evaluation of response (Phase IIa part) [ Time Frame: 18 months ]
    Response to treatment with optimal dose of BT062 (defined in Phase I part) in combination with lenalidomide/dexamethasone or pomalidomide/dexamethasone will be evaluated at baseline and at start of each Cycle (every 28 days). Response evaluation will be primarily based on assessment of M-protein and serum free light chains. If clinically required bone marrow analysis, plasmacytoma evaluation, and skeletal survey will be performed.
Original Primary Outcome Measures  ICMJE
 (submitted: July 11, 2012)
  • Determination of optimal dose of BT062 (Phase I part) [ Time Frame: 6 months ]
    The Phase I part will follow a standard dose escalation design with at least 3 patients per dose level to define optimal dose of BT062 in combination with lenalidomide/dexamethasone. Optimal dose will be defined by dose limiting toxicities (DLT) observed during Cycle 1 (28 days).
  • Evaluation of response (Phase IIa part) [ Time Frame: 18 months ]
    Response to treatment with optimal dose of BT062 (defined in Phase I part) in combination with lenalidomide/dexamethasone will be evaluated at baseline and at start of each Cycle (every 28 days). Response evaluation will be primarily based on assessment of M-protein and serum free light chains. If clinically required bone marrow analysis, plasmacytoma evaluation, and sketetal survey will be performed.
Change History Complete list of historical versions of study NCT01638936 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2016)
  • Qualitative toxicities of BT062 in combination with lenalidomide/dexamethasone or pomalidomide/dexamethasone [ Time Frame: 24 months ]
    Safety will be assessed at each visit by incidence of adverse events and by clinically significant changes in the patients physical examination, vital signs, and clinically laboratory results
  • Pharmacokinetics of BT062 in combination with lenalidomide/dexamethasone or pomalidomide/dexamethasone [ Time Frame: 24 months ]
    Pharmacokinetic parameters will be assessed from plasma by measuring intact BT062 and free maytansinoid (DM4)
  • Assessment of Time To Event end points [ Time Frame: 24 months ]
    Based on the response evaluation, the following Time To Event end points will be evaluated: Time To Progression, Progression Free Survival, Time To Next Treatment, Duration Of Response, Overall survival.
  • Quantitative toxicities of BT062 in combination with lenalidomide/dexamethasone or pomalidomide/dexamethasone [ Time Frame: 24 months ]
    Safety will be assessed at each visit by incidence of adverse events and by clinically significant changes in the patients physical examination, vital signs, and clinically laboratory results
Original Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2012)
  • Qualitative and quantitative toxicities of BT062 in combination with lenalidomide/dexamethasone [ Time Frame: 24 months ]
    Safety will be assessed at each visit by incidence of adverse events and by clinically significant changes in the patients physical examination, vital signs, and clinically laboratory results
  • Pharmacokinetics (Cmax, half-life, AUC) of BT062 in combination with lenalidomide/dexamethasone [ Time Frame: 24 months ]
    Pharmacokinetic parameters will be assessed from plasma by measuring intact BT062 and free maytansinoid (DM4)
  • Assessment of Time To Event end points [ Time Frame: 24 months ]
    Based on the response evaluation, the following Time To Event end points will be evaluated: Time To Progression, Progression Free Survival, Time To Next Treatment, Duration Of Response, Overall survival.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BT062 in Combination With Lenalidomide or Pomalidomide and Dexamethasone in Patients With Multiple Myeloma
Official Title  ICMJE A Phase I/IIa Multi-dose Escalation Study of BT062 in Combination With Lenalidomide or Pomalidomide and Dexamethasone in Subjects With Relapsed or Relapsed/Refractory Multiple Myeloma
Brief Summary The purpose of this study is to test safety and anti-tumor activity of BT062 in combination with lenalidomide and dexamethasone to define the best doses for treating patients with relapsed and refractory multiple myeloma.
Detailed Description BT062 is an antibody-drug conjugate designed to bind and destroy Myeloma cells. The study drug is being given in multiple doses with standard Multiple Myeloma treatments, lenalidomide and dexamethasone, to test how well the treatments are tolerated and work together. This study is a dose escalation study with the purpose to find out the highest dose of BT062 that a subject can tolerate in combination with lenalidomide and dexamethasone.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE Drug: 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 Name: Indatuximab Ravtansine
Study Arms  ICMJE Experimental: 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
Intervention: Drug: BT062 , intravenous administration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 18, 2016)
64
Original Estimated Enrollment  ICMJE
 (submitted: July 11, 2012)
49
Actual Study Completion Date  ICMJE October 30, 2018
Actual Primary Completion Date October 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • Diagnosis of active Multiple Myeloma according to the International Myeloma Working Group (IMWG) diagnostic 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:

  • Chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to day 1 or those who have not recovered from adverse events (AEs) due to agents administered more than 3 weeks earlier
  • 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01638936
Other Study ID Numbers  ICMJE 983
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Biotest Pharmaceuticals Corporation
Study Sponsor  ICMJE Biotest Pharmaceuticals Corporation
Collaborators  ICMJE Biotest
Investigators  ICMJE
Study Director: Kenneth C Anderson, MD Dana-Farber Cancer Institute
PRS Account Biotest Pharmaceuticals Corporation
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP