Proleukin Observational Registry to Evaluate the Treatment Patterns and Clinical Response in Malignancy

Trial Information

Proleukin Observational Registry to Evaluate the Treatment Patterns and Clinical Response in Malignancy

The PROCLAIM Registry is a US-based, multicenter Registry designed to establish a high
quality observational database of real-world clinical data on HD IL-2 when used to treat
patients with mRCC, mM or other malignancies. The Registry will not, in any way, suggest
changes in the treatment or management of the patients enrolled in the Registry. Therefore,
physicians will continue to manage and treat patients according to standard of care and
their own judgment.

The PROCLAIM Registry will start with a retrospective pilot data collection from a
de-identified finite number of patient cases abstracted from their existing medical charts.
The features collected will be identical to those planned for the prospective registry. The
resulting database will be used to formulate hypotheses to be tested using the prospective
registry database. Patients utilized in the retrospective analysis will be excluded from the
prospective portion of the Registry.

In the prospective portion of the Registry, sites will enroll patients who are expected to
start a course of HD IL-2 therapy. Once enrolled, the patient must receive at least one dose
of HD IL-2 to remain in the Registry. Patients will be treated and followed according to the
site's standard of care. This Registry will in no way induce changes in the management of
individual patients. Clinical data features will be entered into an Electronic Data Capture
(EDC) system, and organized into a registry database.

The data contained in the registry database will be observational data. The PROCLAIM
Registry does not stipulate patient care, specific visits or interventions but merely
surveys standardized parameters regarding HD IL-2 and associated therapies as they are
applied by treatment centers. The collection of standard data over time permits the
evaluation of trends in patient survival and subsequent therapy exposure. The database will
be used to answer future queries formulated by researchers.