Cellectar_DCL-16-001 - Clinical Trial

What is the Purpose of this Study?


We are doing this study to find out if an experimental drug called CLR 131 (the study drug) is a safe and effective option for the treatment of multiple myeloma, certain lymphomas, and Waldenstrom's macroglobulinemia.

What is the Condition Being Studied?

Multiple Myeloma, Certain Lymphomas, Waldenstrom's Macroglobulinemia

Who Can Participate in the Study?

Key Eligibility

Adults ages 18+ who:
- Are diagnosed with multiple myeloma; OR
- Are diagnosed with Waldenstrom's macroglobulinemia or lymphoplasmacytic lymphoma and have received at least 2 treatment regimens, and may have either had a limited response to or failed treatment with a tyrosine kinase inhibitor (such as ibrutinib); OR
- Are diagnosed with lymphoma that has returned after standard therapy and are unable to repeat the therapy

For more information about who can join this study, please contact the study team at terri.lucas@duke.edu.

Age Group

What is Involved?


If you choose to join this study, you will begin a screening period to find out if you are eligible. During this time, you will:
- Have a physical exam
- Have a bone marrow biopsy
- Have a heart scan (ECG)
- Have a COVID-19 test
- Have blood draws
- Have imaging done (CT or MRI)

The screening period may last up to 4 weeks. Results of the listed tests will determine if you can participate in the study.

If you are eligible for the study and choose to proceed, we will schedule you to begin receiving the study drug. The drug is given as an intravenous infusion (IV, through a catheter in a vein in your arm) that lasts up to 30 minutes. The drug is given in time periods called "cycles," which last for 30 days. You will get the study drug on the first and fifteenth day of each cycle. Before each infusion, you will take a medication (potassium iodide) that helps reduce radiation exposure to the thyroid gland.

You will have your heart monitored continuously for approximately 24 hours when you take the study drug, starting one hour before the infusion and ending the next day. This will be done using a machine called a Holter monitor that you will wear.

After the screening visit, you will have at least 18 visits to Duke during the study. These visits will be for study drug administration and blood draws to monitor your safety.

Study Details

Full Title
An Open-Label, Multicenter, Phase 2 Study of CLR 131 in Patients with Relapsed or Refractory (R/R) Select B-Cell Malignancies (CLOVER-1) and Expansion Cohort in Patients with Waldenstrom Macroglobulinemia (CLOVER-WaM)
Principal Investigator
Cellular Therapy Specialist
Protocol Number
IRB: PRO00111268
NCT: NCT02952508
Phase II
Enrollment Status
Open for Enrollment