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.
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.
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 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.
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.
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.
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.
Enrollment: 80 patients (estimated)View More
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.
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.
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Read the latest news and updates on this trial.
December 16, 2019
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).
November 04, 2019
October 01, 2019
September 27, 2019
May 13, 2019
Fast Track Designation is granted to drugs being developed for the treatment of serious or life-threatening diseases or conditions where there is an unmet medical need. The purpose of the Fast Track Designation provision is to help facilitate development and expedite the review of drugs to treat serious and life-threatening conditions.
February 25, 2019
Cellectar Biosciences, Inc., a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announced additional positive top-line results from its ongoing Phase 2 clinical study of CLR 131, the company’s lead product candidate.
February 02, 2019
Myeloma patients who had relapsed after receiving both a proteasome inhibitor (like Velcade) and immunomodulator (like Revlimid) participated in a Phase I study of a new drug called CLR 131 and experienced an average 22 month overall survival.
January 07, 2019
Cellectar Biosciences announced median overall survival (mOS) in Cohorts 1-4 of the company’s ongoing Phase 1 clinical trial...
October 02, 2018
Cellectar Biosciences today updates interim overall survival (OS) data from the company’s ongoing Phase 1b clinical trial evaluating CLR 131...
August 20, 2018
Cellectar Biosciences announces data from Cohort 5 of the company’s ongoing Phase 1b clinical trial evaluating CLR 131...
November 07, 2017
Cellectar Biosciences, Inc. today announces that the ongoing median overall survival (mOS) from Cohort 1 of the Phase 1 study...
May 26, 2016
Cellectar Biosciences has been issued a patent for its proprietary drug delivery technology, called phospholipid-ether drug conjugate (PDC).
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