Status:
WITHDRAWN
A Phase IIa Study of Sotatercept on Bone Mass and Turnover in Patients With Multiple Myeloma
Lead Sponsor:
Rebecca Silbermann
Collaborating Sponsors:
Celgene
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Lytic bone disease continues to be one of the most devastating complications of multiple myeloma (MM) despite recent and dramatic advancements in MM management, and bone lesions persist and can contin...
Eligibility Criteria
Inclusion
- Age \> 18 years at the time of signing the informed consent form.
- Documented diagnosis of Multiple Myeloma, currently with complete response (CR) or very good partial response (VGPR) (as defined by IMWG criteria), at least two years after induction therapy or autologous stem cell transplant.
- Patients must not be receiving anti-Myeloma therapy (including maintenance therapy).
- Disease response must be confirmed with repeat laboratory studies at least 30 days apart.
- Radiologic evidence of at least 1 measurable lytic lesion in the arm, pelvis or leg. Completion of two years monthly zoledronic acid therapy.
- Eastern Cooperative Group (ECOG) performance status 0- 2
- Creatinine ≤1.5 x upper limit of normal (ULN) or ≥40 mL/min
- Total bilirubin ≤ 3.0 mg/dL (bilirubin ≤1.5 x upper limit normal)
- AST (SGOT) and ALT (SGPT) ≤ 3.0 x ULN and ≤ 5.0 ULN for subjects with liver metastases
- Hemoglobin ≥ 7.5 g/dL and ≤ 13 g/dL
- Absolute neutrophil count ≥1500/uL
- Platelet count ≥ 75,000/ uL (\>72 hours since prior platelet transfusion)
- Corrected calcium within normal limits, previous hypercalcemia allowed
- Females of childbearing potential must use a highly effective method of birth control for at least 28 days before starting study, during participation and at least 112 days following last dose of sotatercept.
- Males must use latex condom or non-latex condom not made of (animal) membrane during any sexual contact with female of childbearing potential while participating in the study and for at least 112 days following the last dose of sotatercept, even if he has undergone successful vasectomy.
Exclusion
- History of thrombosis, deep vein thrombosis, pulmonary emboli, or embolic stroke AND have not been stable on anticoagulants within the past 6 months. Local central line thrombosis is allowed.
- History of polycythemia
- Uncontrolled hypertension (systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg.)
- History of severe allergic or anaphylactic reaction or hypersensitivity to recombinant proteins or excipients in investigational product.
- Current use of anti-cancer cytotoxic chemotherapeutic agents.
- Major surgery within 30 days of Day 1 of trial.
- Incomplete recovery or incomplete healing of wounds from previous surgery, as determined by treating Investigator.
- Subjects with classification of 3 or higher heart failure as classified by the New York Heart Association (NYHA). Please see Appendix IV.
- Women who are pregnant or breastfeeding or planning to become pregnant or breastfeed during the period of treatment and for 112 days following the last dose of sotatercept.
- Treatment with another investigational drug or device within 28 days prior to Day 1, or if the half-life of the previous product is known, within 5 times the half-life of the investigational drug prior to dosing, whichever is longer.
- Prior exposure to sotatercept.
- Any significant medical condition, laboratory abnormality, or psychiatric illness that, as determined by the treating Investigator, would prevent the subject from participating in the study or providing written informed consent.
- Any condition including the presence of laboratory abnormality that, as determined by the treating Investigator, places the subject at unacceptable risk if he/she were to participate in the study.
- Known positive for human immunodeficiency virus (HIV)
- Known positive for infectious hepatitis type C or active infectious hepatitis type B.
- Any condition that, as determined by the treating Investigator, confounds the interpretation of data from the study.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02230917
Start Date
October 1 2014
End Date
June 1 2016
Last Update
September 1 2016
Active Locations (1)
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1
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States, 46202