An Open-Label, Multicenter, Phase 2 Study of CLR 131 in Patients with Relapsed or Refractory (R/R) Select B-Cell Malignancies CLOVER-1
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What's the purpose of this trial?

This trial is being done to help determine if the investigative drug 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's being studied?

  • CLR 131 is designed to provide targeted delivery of radiation to malignant tumor cells. In other words, this compound is made to attack cells with cancer rather than cells without cancer.
  • Dexamethasone is a steroid given in conjunction with some cancer treatments.

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 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 CLR 131 if researchers think it will be safe and help your myeloma.

Patients may be eligible to receive financial assistance for travel and lodging purposes from Cellectar if enrolled in the study. Eligibility to receive financial assistance may vary depending on the site policies where a patient is planning to enroll.

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.

Study Medications

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.

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 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.


Additional Trial Information

Phase 2

Enrollment: 80 patients (estimated)

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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. Create your account or call us today for help (888) 828-2206.

  • Have progressive, measurable myeloma
  • Have had two or more lines of therapy for myeloma
  • Have not had a stem cell transplant in the last three months

Published Results

Cellectar Reports Data on CLR 131 Phase 2 CLOVER-1 Study in Triple Class Refractory Multiple Myeloma Patients

September 09, 2020

The 40% ORR (6/15 patients) represents triple class refractory patients enrolled in Part A of Cellectar’s CLOVER-1 study and additional patients enrolled in Part B from March through May 2020. As a reminder, all patients being enrolled in Part B are required to be triple class refractory. The additional six patients were heavily pre-treated with an average of 9 prior multi-drug regimens. Three patients received a total administered dose of greater than 60 mCi and three received less than 60 mCi. Consistent with the data released in February 2020, patients receiving greater than 60 mCi exhibit strong responses. Patients continue to tolerate CLR 131 well, with the most common and almost exclusive treatment emergent adverse events being cytopenias and importantly, no unexpected adverse events have been reported.

Fractionated Dosing of CLR 131 in Patients with Relapsed or Refractory Multiple Myeloma Presented at the 61st Annual American Society of Hematology Conference

December 09, 2019

Dr. Ailawadhi's presentation highlighted results from 19 patients with relapsed/refractory multiple myeloma from Cellectar’s Phase 1 and Phase 2 CLOVER-1 trial collected prior to July 30, 2019. The data from the oral presentation support prior literature and preclinical data showing that fractionated dosing provides an enhancement of efficacy and safety while reducing adverse events.

  • The patients presented received one of 3 dose levels: a single bolus dose of 31.25 mCi/m2 or a fractionated dose of 31.25 mCi/m2 or a higher fractionated dose of 37.5 mCi/m2 of CLR 131.
  • The fractionated 37.5 mCi/m2 dose of CLR 131 represents the greatest amount of drug administered to date in the Phase 2 CLOVER-1 trial.
  • The overall response rate (ORR) for all multiple myeloma patients across the 3 dose cohorts was 31.3% and a 100% disease control rate.
  • Patients receiving the higher fractionated 37.5 mCi/m2 dose demonstrated a 50% ORR with the remaining 50% having minimal responses (greater than a 25% reduction in the surrogate marker of efficacy).

Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

California

Redlands Community Hospital

Redlands, CA

Open and Accepting

Florida

Mayo Clinic (Jacksonville)

Jacksonville, FL

Open and Accepting

Illinois

Loyola University Medical Center Cardinal Bernardin Cancer Center

Maywood, IL

Open and Accepting

Ohio

The Christ Hospital

Cincinnati, OH

Open and Accepting

South Carolina

Prisma Health Greenville Memorial Hospital

Greenville, SC

Open and Accepting

Washington

Wisconsin

UW Carbone Cancer Center University of Wisconsin Health

Madison, WI

Open and Accepting

Trial Links

Read the latest news and updates on this trial.


Fractionated Dosing of CLR 131 in Patients with Relapsed or Refractory Multiple Myeloma Presented at the 61st Annual American Society of Hematology Conference

December 09, 2019

The data from the oral presentation support prior literature and preclinical data showing that fractionated dosing provides an enhancement of efficacy and safety while reducing adverse events. The patients presented received one of 3 dose levels: a single bolus dose of 31.25 mCi/m2 or a fractionated dose of 31.25 mCi/m2 or a higher fractionated dose of 37.5 mCi/m2 of CLR 131. The fractionated 37.5 mCi/m2 dose of CLR 131 represents the greatest amount of drug administered to date in the Phase 2 CLOVER-1 trial. The overall response rate (ORR) for all multiple myeloma patients across the 3 dose cohorts was 31.3% and a 100% disease control rate. Patients receiving the higher fractionated 37.5 mCi/m2 dose demonstrated a 50% ORR with the remaining 50% having minimal responses (greater than a 25% reduction in the surrogate marker of efficacy).

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