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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

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

Thank you

Trial Information

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

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

Inclusion 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

- 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

- 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

- 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

Type of Study:


Study Design:

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

Outcome Measure:

Determination of optimal dose of BT062 (Phase I part)

Outcome Description:

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).

Outcome Time Frame:

6 months

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:

July 2012

Completion Date:

November 2014

Related Keywords:

  • Multiple Myeloma
  • Combination
  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



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Mayo ClinicJacksonville, Florida  32224
City of HopeDuarte, California  91010
University of Texas Health Science CenterSan Antonio, Texas  78284