An Open-Label, Multicenter, Phase 2 Study of CLR 131 in Patients with Relapsed or Refractory (R/R) Select B-Cell Malignancies (CLOVER-1) Verified

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 that also has anti-cancer activity.

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.


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
View Additional Criteria

Published Results

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

Accepting

Florida

Mayo Clinic (Jacksonville)

Jacksonville, FL

Accepting

Illinois

Loyola University Medical Center Cardinal Bernardin Cancer Center

Maywood, IL

Accepting

Northwestern Medicine Cancer Center Warrenville

Warrenville, IL

Accepting

Kansas

University of Kansas Cancer Center

Kansas City, KS

Accepting

Louisiana

Ochsner Medical Center

Jefferson, LA

Accepting

New York

University of Rochester Medical Center James P. Wilmot Cancer Center

Rochester, NY

Accepting

South Carolina

Prisma Health Greenville Memorial Hospital

Greenville, SC

Accepting

Washington

Wisconsin

UW Carbone Cancer Center University of Wisconsin Health

Madison, WI

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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