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Safety and Dose Determining Study of BT062 in Patients With Relapsed or Refractory Multiple Myeloma

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BT062
Sponsored by
Biotest Pharmaceuticals Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, Refractory, Relapsed

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of active multiple myeloma according to the International Myeloma Working Group diagnostic criteria
  • Relapsed or relapsed/refractory multiple myeloma
  • Previous treatment with both an immunomodulator and a proteosome inhibitor therapy
  • Age ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status (Zubrod) ≤ 2
  • Ability to understand and willingness to sign a written informed consent document
  • Ability to adhere with the study visit schedule and other protocol procedures
  • Life expectancy of ≥ 12 weeks
  • Normal organ and marrow function

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 AEs due to agents administered more than 3 weeks earlier
  • Treatment with another investigational agent during the study or within 4 weeks before day 1
  • Major surgery within 4 weeks before day 1 (this does not include placement of vascular access device or tumor biopsies)
  • Antineoplastic therapy with biological agents within 2 weeks before day 1
  • HAHAs, HACAs, or HAMAs in response to previous MAb therapy
  • Previous participation in this study
  • Malignancy within 3 years before day 1, excluding treated non-melanoma skin cancer, superficial bladder cancer and carcinoma in-situ of the cervix
  • Severe diseases of skin, colon, esophagus, or eye within 1 year before day 1, as judged by the Investigator
  • Severe infections necessitating use of antibiotics
  • Clinically relevant active infection including active hepatitis B or C or human immunodeficiency virus (HBV, HCV, or HIV) or any other concurrent disease which,in the judgment of the investigator, would make the subject inappropriate for enrollment into this study
  • Acute or relevant abnormalities in electrocardiogram (ECG), as judged by the Investigator
  • Significant cardiac disease such as recent myocardial infarction (≤ 6 months prior to day 1), unstable angina, uncontrolled congestive heart failure, uncontrolled hypertension, (recurrent or persistent increases in systolic blood pressure ≥ 180 mm Hg or diastolic blood pressure ≥ 110 mm Hg), uncontrolled cardiac arrhythmias, grade 3 or greater cardiac toxicity from prior chemotherapy
  • History of clinically significant drug or alcohol abuse
  • Unwillingness or inability to adhere to the requirements of the study
  • Concomitant therapy with corticosteroids (except as indicated in low dose for other medical conditions such as inhaled steroid for asthma, or as premedication for administration of certain medications or blood products and for treatment of infusion reactions if needed)
  • Concomitant antineoplastic therapies including chemotherapy, radiotherapy, or biological agents during the study
  • Any condition, including laboratory abnormalities, that in the opinion of the Investigator places the subject at unacceptable risk if he or she are included in the study
  • Pregnant or breast-feeding
  • Unwillingness to use an effective contraceptive method during the study and at least 3 months after administration of study drug - unless subject is naturally infertile. (Acceptable contraceptive methods include oral or injectable contraceptives, intrauterine devices (IUD), double-barrier method, contraceptive patch, surgical sterilization, or condoms.)
  • Positive serum or urine pregnancy test

Sites / Locations

  • Emory University Winship Cancer Institute
  • Dana-Farber Cancer Institute
  • Roswell Park Cancer Institute
  • Mount Sinai Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BT062

Arm Description

BT062 single agent dose escalation

Outcomes

Primary Outcome Measures

Dose limiting toxicity
Maximum tolerated dose

Secondary Outcome Measures

Qualitative and quantitative toxicities
Pharmacokinetics
Anti-tumor activity

Full Information

First Posted
July 24, 2008
Last Updated
July 16, 2013
Sponsor
Biotest Pharmaceuticals Corporation
Collaborators
Biotest
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1. Study Identification

Unique Protocol Identification Number
NCT00723359
Brief Title
Safety and Dose Determining Study of BT062 in Patients With Relapsed or Refractory Multiple Myeloma
Official Title
A Phase I Dose Escalation Study to Evaluate Maximum Tolerated Dose (MTD), Pharmacokinetics (PK), and Safety of BT062 in Subjects With Relapsed or Relapsed/Refractory Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotest Pharmaceuticals Corporation
Collaborators
Biotest

4. Oversight

5. Study Description

Brief Summary
This Phase I research study is to test the effects (good and bad) and best dose of BT062 in treating patients with relapsed or refractory multiple myeloma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma, Refractory, Relapsed

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BT062
Arm Type
Experimental
Arm Description
BT062 single agent dose escalation
Intervention Type
Drug
Intervention Name(s)
BT062
Intervention Description
biologic
Primary Outcome Measure Information:
Title
Dose limiting toxicity
Time Frame
On a weekly basis for the duration of the study
Title
Maximum tolerated dose
Time Frame
About every 2 months for the duration of the study
Secondary Outcome Measure Information:
Title
Qualitative and quantitative toxicities
Time Frame
On a weekly basis for the duration of the study
Title
Pharmacokinetics
Time Frame
On a weekly basis for the duration of the study
Title
Anti-tumor activity
Time Frame
At the beginning of each treatment cycle

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of active multiple myeloma according to the International Myeloma Working Group diagnostic criteria Relapsed or relapsed/refractory multiple myeloma Previous treatment with both an immunomodulator and a proteosome inhibitor therapy Age ≥ 18 years Eastern Cooperative Oncology Group (ECOG) performance status (Zubrod) ≤ 2 Ability to understand and willingness to sign a written informed consent document Ability to adhere with the study visit schedule and other protocol procedures Life expectancy of ≥ 12 weeks Normal organ and marrow function 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 AEs due to agents administered more than 3 weeks earlier Treatment with another investigational agent during the study or within 4 weeks before day 1 Major surgery within 4 weeks before day 1 (this does not include placement of vascular access device or tumor biopsies) Antineoplastic therapy with biological agents within 2 weeks before day 1 HAHAs, HACAs, or HAMAs in response to previous MAb therapy Previous participation in this study Malignancy within 3 years before day 1, excluding treated non-melanoma skin cancer, superficial bladder cancer and carcinoma in-situ of the cervix Severe diseases of skin, colon, esophagus, or eye within 1 year before day 1, as judged by the Investigator Severe infections necessitating use of antibiotics Clinically relevant active infection including active hepatitis B or C or human immunodeficiency virus (HBV, HCV, or HIV) or any other concurrent disease which,in the judgment of the investigator, would make the subject inappropriate for enrollment into this study Acute or relevant abnormalities in electrocardiogram (ECG), as judged by the Investigator Significant cardiac disease such as recent myocardial infarction (≤ 6 months prior to day 1), unstable angina, uncontrolled congestive heart failure, uncontrolled hypertension, (recurrent or persistent increases in systolic blood pressure ≥ 180 mm Hg or diastolic blood pressure ≥ 110 mm Hg), uncontrolled cardiac arrhythmias, grade 3 or greater cardiac toxicity from prior chemotherapy History of clinically significant drug or alcohol abuse Unwillingness or inability to adhere to the requirements of the study Concomitant therapy with corticosteroids (except as indicated in low dose for other medical conditions such as inhaled steroid for asthma, or as premedication for administration of certain medications or blood products and for treatment of infusion reactions if needed) Concomitant antineoplastic therapies including chemotherapy, radiotherapy, or biological agents during the study Any condition, including laboratory abnormalities, that in the opinion of the Investigator places the subject at unacceptable risk if he or she are included in the study Pregnant or breast-feeding Unwillingness to use an effective contraceptive method during the study and at least 3 months after administration of study drug - unless subject is naturally infertile. (Acceptable contraceptive methods include oral or injectable contraceptives, intrauterine devices (IUD), double-barrier method, contraceptive patch, surgical sterilization, or condoms.) Positive serum or urine pregnancy test
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth C. Anderson, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Study Director
Facility Information:
Facility Name
Emory University Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Safety and Dose Determining Study of BT062 in Patients With Relapsed or Refractory Multiple Myeloma

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