A Phase 3, Randomized, Open Label Trial of Lenalidomide/dexamethasone With or Without Elotuzumab in Relapsed or Refractory Multiple Myeloma

Overview

No summary available.

Registry

who.int

Start Date

August 11, 2011

End Date

TBD

Last Updated

4 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performance of any study\-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care.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) Age \>or\= 18 years or legal age of consent per local regulations
•b) ECOG performance status c) Life\-expectancy \> 3 months
•d) Documented evidence of multiple myeloma and
•i) Received between 1 to 3 prior lines of therapy with documented progression by EBMT criteria after the most recent therapy AND
•ii) Measureable disease: serum IgG, IgA, IgM M\-protein \>or\= 0\.5 g/dL or serum IgD M\-protein \>or\= 0\.05 g/dL or \>or\= 200 mg urinary M\-protein excretion /24\-hour.
•e) Prior lenalidomide exposure is permitted only if they fulfill all of the following:

•1\) Target Disease Exceptions
•a) Subjects with non\-secretory or oligo\-secretory or free light\-chain only myeloma
•b) Active plasma cell leukemia (defined as either 20% of peripheral WBC comprised of plasma/CD138\+ cells or an absolute count of 2 x 10E9/L).
•2\) Medical History and Concurrent Diseases
•a) All Adverse Events of any prior chemotherapy, surgery, or radiotherapy not resolved to NCI CTCAE (v. 3\.0\) Grade b) Known or suspected cardiac amyloidosis; POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
•c) Significant cardiac disease as determined by the investigator including:
•i) Known or suspected cardiac amyloidosis
•ii) Congestive heart failure of Class III or IV of the NYHA classification;
•iii) Uncontrolled angina, hypertension or arrhythmia
•iv) Myocardial infarction in past 6 months