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

NCT00723359 | Completed Phase 1

• 1 other identifier: 969
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 4

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.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; Refractory; Relapsed

Outcome Measures

Primary Outcomes (2)

• Dose limiting toxicity

  On a weekly basis for the duration of the study

• Maximum tolerated dose

  About every 2 months for the duration of the study

Secondary Outcomes (3)

• Qualitative and quantitative toxicities

  On a weekly basis for the duration of the study

• Pharmacokinetics

  On a weekly basis for the duration of the study

• Anti-tumor activity

  At the beginning of each treatment cycle

Study Arms (1)

BT062

EXPERIMENTAL

BT062 single agent dose escalation

Drug: BT062

Interventions

BT062 DRUG

biologic

BT062

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Biotest Pharmaceuticals Corporation: lead
• Biotest: collaborator

Study Sites (4)

Emory University Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Recurrence

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kenneth C. Anderson, MD

  Dana-Farber Cancer Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2008
• First Posted: July 28, 2008
• Study Start: August 1, 2008
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: July 18, 2013

Record last verified: 2013-07

Locations

US (4)