Phase 2a Single-Arm Safety Study of Elotuzumab in Combination with Thalidomide and Dexamethasone in Subjects with Relapsed and/or Refractory Multiple Myeloma

Overview

No summary available.

Registry

who.int

Start Date

February 28, 2012

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\) Signed Written Informed Consent
•a) Subject is, in the investigator?s opinion, willing and able to comply with the protocol requirements.
•b) Subject has given voluntary written informed consent before performance of any study\-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care.
•2\) Target Population
•a) Eastern Cooperative Oncology Group (ECOG) performance status 0 \- 1 for the TdE safety\-lead in cohort; performance status of 0 \- 2 for additional subjects.
•b) Confirmed diagnosis of previously treated multiple myeloma with documented progression by IMWG criteria after or during the most recent therapy. There is no limit to the number of prior lines of therapy.
•c) Measurable disease as defined by at least one of the following:
•i) Serum IgG, IgA or IgM M\-protein \>or\= 0\.5 g/dL, or serum IgD M\-protein \>or\= 0\.05 g/dL, OR
•ii) Urine M protein \>or\= 200 mg excreted in a 24\-hour collection sample; OR
•iii) Involved serum free light chain level \>or\= 10 mg/dL provided the free light chain ratio is abnormal

•1\) Target Disease Exceptions
•a) Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia.
•b) MGUS, smoldering myeloma or Waldenström?s macroglobulinemia.
•c) Active plasma cell leukemia (defined as either 20% of peripheral WBC comprised of plasma/CD138\+ cells or an absolute plasma cell count of 2 x 109 /L).
•d) Subjects with non\-secretory myeloma.
•2\) Medical History and Concurrent Diseases
•a) Any medical conditions that, in the investigator?s opinion, would impose excessive risk to the subject. Examples of such conditions include:
•i) Any uncontrolled disease, such as pulmonary disease, infection, or seizure disorder
•ii) Any altered mental status or any psychiatric condition that would interfere with the understanding of the informed consent
•b) Significant cardiac disease as determined by the investigator, including: