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Trial record 1 of 3 for:    BT062 AND Multiple Myeloma
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BT062 in Combination With Lenalidomide or Pomalidomide and Dexamethasone in Patients With Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT01638936
Recruitment Status : Active, not recruiting
First Posted : July 12, 2012
Last Update Posted : September 1, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: BT062 , intravenous administration Phase 1 Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2012
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : November 2018


Arms and Interventions

Arm Intervention/treatment
Experimental: BT062 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


Outcome Measures

Primary Outcome Measures :
  1. 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).

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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)

  3. 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.

  4. 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


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01638936


Locations
United States, California
City of Hope
Duarte, California, United States, 91010
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
Memorial Healthcare System
Pembroke Pines, Florida, United States, 33028
United States, Georgia
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10029
United States, Texas
University of Texas Health Science Center
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Biotest Pharmaceuticals Corporation
Biotest
Investigators
Study Director: Kenneth C Anderson, MD Dana-Farber Cancer Institute
More Information

Responsible Party: Biotest Pharmaceuticals Corporation
ClinicalTrials.gov Identifier: NCT01638936     History of Changes
Other Study ID Numbers: 983
First Posted: July 12, 2012    Key Record Dates
Last Update Posted: September 1, 2017
Last Verified: August 2017

Keywords provided by Biotest Pharmaceuticals Corporation:
Combination
Multiple Myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Lenalidomide
Pomalidomide
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents