64Cu-LLP2A for Imaging Hematologic Malignancies

Early Phase I Evaluation of 64Cu-LLP2A for Imaging Hematologic Malignancies Part B

This phase of the protocol (protocol part B), seeks to evaluate the new formulation in healthy normal volunteers to confirm the new formulation provides comparable human dosimetry to which was seen and published in protocol part A. Additionally, the new formulation will be studied utilizing an expanded patient population to include patients with confirmed diagnosis of multiple myeloma (MM), low-grade lymphoma, or MM and lymphoma patients who are status post bone marrow transplant (BMT) with negative imaging and suspected recurrence.

Inclusion Criteria Healthy Volunteer:

• Adult 18 years of age or older
• Able to give informed consent.
• Able to comprehend and willing to follow instructions for study procedures as called for by the protocol
• Capable of lying still and supine within the PET/CT scanner for up to 75 minutes.
• No illicit drug use or other inhaled drug use (including pharmacologic agents and illicit drugs) within the past year per self-reporting mechanisms.
• No history of claustrophobia or other condition that has previously or would interfere with completion of protocol specified imaging sessions.
• Not currently pregnant or nursing: Subject must be surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), post-menopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of 64Cu-LLP2A) is negative.

Inclusion Criteria Hematological Malignancy:

• Clinical or pathologically defined MM or lymphoma including both newly diagnosed, relapsed or refractory disease:

  • Multiple Myeloma defined in accordance with the International Myeloma Working Group criteria
  • Low-grade lymphoma, including the following subtypes: follicular lymphoma, marginal zone lymphoma, lymphoplasmacytic lymphoma, small lymphocytic lymphoma/chronic lymphocytic leukemia

• Adult 18 years of age or older and able to provide informed consent

• Capable of lying still and supine within the PET/CT scanner for up to 75 minutes.

• No history of claustrophobia or other condition that has previously or would interfere with completion of protocol specified imaging sessions

• Not currently pregnant or nursing: Subject must be surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), post-menopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of 64Cu-LLP2A) is negative

• Patients participating in imaging or therapeutic trials with investigational agents are eligible to participate