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

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
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