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A Phase I/IIa Multi-Dose Escalation Study to Evaluate Maximum Tolerated Dose (MTD), Pharmacokinetics (PK), Safety and Efficacy of BT062 in Subjects With Relapsed or Relapsed/Refractory Multiple Myeloma

Phase 1/Phase 2
18 Years
Open (Enrolling)
Multiple Myeloma

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Trial Information

A Phase I/IIa Multi-Dose Escalation Study to Evaluate Maximum Tolerated Dose (MTD), Pharmacokinetics (PK), Safety and Efficacy of BT062 in Subjects With Relapsed or Relapsed/Refractory Multiple Myeloma

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

- Known HAHAs, HACAs, or HAMAs in response to previous MAb therapy

- Previous treatment with BT062

- Malignancy within 3 years before day 1, other than the trial indication multiple
myeloma and 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 / antivirals during the screening

- 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. These abnormalities can be defined as recent myocardial infarction,
uncontrolled cardiac arrhythmias and/or pronounced disturbances of the electrical
conduction system of the heart.

- 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 (Lown Criteria) 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, topical use, or as
premedication for administration of certain medications (including BT062) 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose limiting toxicities

Outcome Time Frame:

On a weekly basis for the duration of the study

Safety Issue:


Principal Investigator

Kenneth C. Anderson, MD

Investigator Role:

Study Director

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

August 2010

Completion Date:

December 2013

Related Keywords:

  • Multiple Myeloma
  • Multiple myeloma
  • Relapsed
  • Refractory
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Roswell Park Cancer Institute Buffalo, New York  14263
Dana-Farber Cancer Institute Boston, Massachusetts  02115
The University of Chicago Chicago, Illinois  60637
Emory University Winship Cancer Institute Atlanta, Georgia  30322
The Mount Sinai School of Medicine New York, New York  10029-6547