BT062 in Combination With Lenalidomide/Dexamethasone in Patients With Multiple Myeloma

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Biotest Pharmaceuticals Corporation
Sponsor:
Collaborator:
Biotest
Information provided by (Responsible Party):
Biotest Pharmaceuticals Corporation
ClinicalTrials.gov Identifier:
NCT01638936
First received: March 8, 2012
Last updated: July 16, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
Multiple Myeloma
Drug: BT062 , intravenous administration
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/IIa Multi-dose Escalation Study of BT062 in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed or Relapsed/Refractory Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Biotest Pharmaceuticals Corporation:

Primary Outcome Measures:
  • Determination of optimal dose of BT062 (Phase I part) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Qualitative and quantitative toxicities of BT062 in combination with lenalidomide/dexamethasone [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 49
Study Start Date: July 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  • 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 RevAssist® Program
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01638936

Contacts
Contact: Shailesh Chavan, MD 561-989-5748 schavan@biotestpharma.com
Contact: Pankaj Patel, PhD 561-989-5577 PaPatel@biotestpharma.com

Locations
United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
United States, Florida
Mayo Clinic Recruiting
Jacksonville, Florida, United States, 32224
United States, Georgia
Emory University Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30322
United States, Illinois
The University of Chicago Recruiting
Chicago, Illinois, United States, 60637
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
United States, Texas
University of Texas Health Science Center Recruiting
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

No publications provided

Responsible Party: Biotest Pharmaceuticals Corporation
ClinicalTrials.gov Identifier: NCT01638936     History of Changes
Other Study ID Numbers: 983
Study First Received: March 8, 2012
Last Updated: July 16, 2013
Health Authority: United States: Food and Drug Administration

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
Dexamethasone 21-phosphate
Lenalidomide
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones

ClinicalTrials.gov processed this record on September 18, 2014