The primary purpose of this study is to determine if CLR 131 is effective for the treatment of multiple myeloma or certain lymphomas. CLR 131 is an investigational radioactive drug. The word “investigational” means that CLR 131 is not approved by the U.S. Food and Drug Administration (FDA) and is available for research use only.
Radiotherapy has been used as a cancer therapy for more than 40 years. The goal of targeted radiotherapy is selective delivery (directed to tumor) of effective doses of radioactive isotopes (amount of radiation) that destroy tumor tissue, limit the effect on surrounding normal tissue, do not accumulate in and damage vital organs (especially bone marrow, liver and kidneys), and that can be rapidly eliminated from the body.
In experiments with animals and on cell tissue, CLR 131 has been shown to slow tumor growth. This compound appears to target cells with cancer rather than cells without cancer. As mentioned above, this study is being done to learn more about what effect, if any, CLR 131 has on your cancer and if there are any bad side effects.
CLOVER-1 is a multicenter, open-label, Phase 2 study evaluating intravenous (IV) administration of CLR 131 in patients with B-cell malignancies who have been previously treated with standard therapy for their underlying malignancy.
Multiple myeloma patients must have received at least 2 regimens, including at least 1 approved proteasome inhibitor and at least 1 approved immunomodulatory agent. Multiple myeloma patients must have measurable evidence of disease based on a serum protein electrophoresis (SPEP), 24-hour urine protein electrophoresis (UPEP), or FLC assay (non-secretors are allowed provided the Investigator details a plan to define progressive disease (PD) prior to enrollment and to assess clinical benefit after treatment).
Up to 80 patients are planned for the study. Approximately ten initial patients evaluable for response will be enrolled into each tumor cohort. The study is being done at up to 10 medical centers in the United States and is expected to last about 24 months, but may last longer.
All subjects will receive CLR 131. For patients with multiple myeloma you will also take dexamethasone weekly. You will receive a single injection of the study drug, CLR 131, through an intravenous injection (IV, through a catheter in a vein in your arm) over approximately 30 minutes on day 1 and day 7 of the study.
Before the infusion of CLR 131, you will start a medication (potassium iodide drops) to help reduce the radiation exposure to the thyroid gland. This medicine must be taken by mouth within 24 hours before your dose of CLR 131 and will continue for 21 days after the dose of CLR 131. Your doctor or the study team will tell you how to take this medication.
For patients with multiple myeloma your doctor will instruct you on taking dexamethasone once per week orally (by mouth). You will need to complete a diary showing when you took the medication each week and share this with the study team.
You may be allowed to receive a second cycle of CLR 131 infusions. If your doctor thinks it is appropriate, the second cycle will be given no earlier than 75 days and no later than 180 days following the first cycle of CLR 131. Your doctor or study team will let you know if you are able to receive a second cycle.
After the screening visit, you will have approximately 14 visits to the study site during the study. These visits will be for treatment administration and blood draws to monitor your safety.
You will be actively participating in the study for approximately 85 days as your monitored after the injection of the CLR 131. Following this initial post-infusion safety follow-up period, patients will be followed at the discretion of treating physicians.
You can stop participating at any time. However, if you decide to stop participating in the study, we encourage you to talk to the study doctor and your regular doctor first. Please notify your study doctor if you wish to stop study participation for any reason. Your progress will continue to be followed through your medical records unless you request that access to your records be limited.
The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.
The following criteria is provided for health care professionals.
Patients with Multiple Myeloma
Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Lymphoplasmacytic Lymphoma, or Marginal Zone Lymphoma
Patients with Mantle Cell Lymphoma
Patients with Diffuse Large B-Cell Lymphoma
The following is a listing of trial locations that are open and accepting patients.