What's the purpose of this trial?

This trial is being done to help determine if the investigative drug Iopofosine I 131 (CLR 131) is safe and can be tolerated for the treatment of multiple myeloma or certain lymphomas.

This trial is currently open and accepting patients.

What will happen during the trial?

All patients enrolled in this phase 2 trial will receive the same treatment.

On the first day of the trial, you will receive a dose of Iopofosine I 131 (CLR 131) through an intravenous infusion, and approximately one week later, you will receive a second dose. You will receive dexamethasone weekly as well, for up to three months.

You may be required to visit the study site upwards of 15 times over a three month period.

Patients may be eligible to a second cycle of Iopofosine I 131 (CLR 131) if researchers think it will be safe and help your myeloma.

CLOVER-1 is a multicenter, open-label, Phase 2 study evaluating intravenous (IV) administration of Iopofosine I 131 (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.

Study Medications

All subjects will receive Iopofosine I 131 (CLR 131). For patients with multiple myeloma you will also take dexamethasone weekly. You will receive a single injection of the study drug, Iopofosine I 131 (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 Iopofosine I 131 (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 Iopofosine I 131 (CLR 131) and will continue for 21 days after the dose of Iopofosine I 131 (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 Iopofosine I 131 (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 Iopofosine I 131 (CLR 131). Your doctor or study team will let you know if you are able to receive a second cycle.

Study Visits

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 Iopofosine I 131 (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.

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Additional Trial Information

Phase 2

Enrollment: 80 patients (estimated)