BT062 in Combination With Lenalidomide or Pomalidomide and Dexamethasone in Patients With Multiple Myeloma
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Jacksonville, Florida: 12-002591
NCT ID: NCT01638936
Sponsor Protocol Number: 983
About this study
The purpose of this study is to test safety and anti-tumor activity of BT062 in combination with lenalidomide and dexamethasone to define the best doses for treating patients with relapsed and refractory multiple myeloma.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.See eligibility 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 (BT062/Len/dex)
- Subjects who failed at least two prior therapy (BT062/Pom/dex)
- 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 REVLIMID REMS Program or POMALYST REMS
- Women of child bearing potential (WCBP), must agree to use 2 contraceptive methods
- 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
- Hypersensitivity to the active substance or to any of the excipients for study drug BT062, or history of severe allergic or anaphylactic reaction to therapeutic proteins (e.g. reaction to vaccination or to biological therapy)
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.
|Mayo Clinic Location
Mayo Clinic principal investigator
Asher Chanan-Khan, M.D., M.B.B.S.
Closed for enrollment
Cancer Center Clinical Trials Referral Office