The aim of this research study is to use advanced immunology laboratory analysis to identify a more precise blood test that will predict infection risk in patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL) or Multiple Myeloma (MM).

The goal of this research study is to identify an antigen-specific antibody profiling biomarker associated with increased risk of any infections in patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL) or Multiple Myeloma (MM).

Research procedures including screening for eligibility, clinic visits, and blood tests.

This involves performing blood tests which detect antibodies directed against specific pathogens and measure their functional capacity, and collecting information about outcomes in patients.

Participation in this research study is expected to last 2 years.

It is expected that about 150 people CLL or MM will take part in this research study, and this will predominantly include people with CLL/SLL.

Takeda is supporting this research study by providing funding.

Inclusion Criteria:

• Adults ≥18 years of age.
• Diagnosis of Rai stage I-IV chronic lymphocytic leukemia or small lymphocytic lymphoma or multiple myeloma.
• Subjects must be able to consent to clinical trial, or documented health care proxy agent able to consent on behalf of participant.

Exclusion Criteria:

• Subjects must not have received IVIG administration within 6 calendar months of registration or have planned immunoglobulin replacement therapy by treating investigator at time of registration.
• Subjects with chronic lymphocytic leukemia or small lymphocytic lymphoma must not be Rai stage 0.
• Subjects with multiple myeloma must not have smoldering myeloma or solitary plasmacytoma with or without minimal marrow involvement.
• Subjects must not have undergone prior autologous, allogeneic stem cell, or solid organ transplant.
• Subjects must not have any active systemic infection requiring ongoing antimicrobial treatment (prophylactic antimicrobial allowed) at time of registration.
• Subjects must have no known history of HIV, primary immune deficiency disorder, nor be taking a concurrent immune suppressing medication at time of registration. Treatment for CLL/SLL or MM, CLL/SLL related autoimmune phenomenon, or physiologic dosing of corticosteroids (5mg/day prednisone/equivalent or lower) is permitted.

Diagnoses of Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Multiple Myeloma.

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Data can be shared no earlier than 1 year following the date of publication.

Contact the Partners Innovations team at http://www.partners.org/innovation.