Dose Escalation Study of I-131-CLR1404 in Patients With Relapsed or Refractory Multiple Myeloma

Overview

The primary objective of the study is to determine the safety and tolerability of I-131-CLR1404, with and without concurrent weekly dexamethasone, in patients with relapsed or refractory multiple myeloma who have previously been treated with, or are intolerant of, an immunomodulator and a proteasome inhibitor.
SparkCures ID 756
Trial Phase Phase 1
Enrollment 33 Patients
Treatments
Trial Sponsors
  • Cellectar Biosciences
NCT Identifier

NCT02278315

Am I Eligible?

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.

Inclusion Criteria:

  • Histologically or cytologically confirmed multiple myeloma
  • Prior treatment with or intolerance to proteasome inhibitor and immunomodulator
  • Bone marrow biopsy within 28 days of study drug infusion demonstrating at least 5% plasma cell involvement
  • Progressive disease defined by any of following:
    • 25% increase in serum M-protein from lowest response value during (or after) last therapy and/or absolute increase in serum M-protein of > 0.5 g/dL;
    • 25% increase in urine M-protein from lowest response value during (or after) last therapy and/or absolute increase in urine M-protein of > 200 mg/24h;
    • 25% increase in bone marrow plasma cell percentage from lowest response value during (or after) last therapy - absolute bone marrow plasma cell percentage must be > 10% unless prior complete response when absolute bone marrow plasma cell percentage must be > 5%;
    • new onset hypercalcemia > 11.5 mg/dL
  • Measurable disease defined by any of following:
    • Serum M-protein > 1 g/dL;
    • Urine M-protein > 200 mg/24h;
    • Serum free light chain (FLC) assay: involved FLC level > 10 mg/dL provided serum FLC ratio is abnormal
  • Eastern Cooperative Oncology Group performance status of 0 to 2
  • Life expectancy of at least 6 months
  • Have initiative and means to be compliant with protocol and within geographical proximity to make required study visits as judged by Investigator
  • Subject or legal representative has ability to read, understand and provide written informed consent for study related procedures
  • Women of childbearing potential must have negative pregnancy test within 24 hours of enrollment
  • Women of childbearing potential and men who are able to father a child, must agree to use an effective contraception method during study and for 12 months following study drug administration

Exclusion Criteria:

  • Grade 2 or greater toxicities due to previous therapies, subject to laboratory abnormalities listed below. Stable, tolerable Grade 2 adverse events may be allowed at discretion of Investigator
  • Prior external beam radiation therapy resulting in greater than 20% total bone marrow receiving greater than 20 Gy
  • Prior radioisotope therapy
  • Prior total body or hemi-body irradiation
  • More than one previous, alkylator-based chemotherapy regimen. Transplantation is considered one alkylator-based chemotherapy regimen. Immunomodulators and proteasome inhibitors are not considered alkylator-based chemotherapy regimens
  • Subject has received severely marrow toxic drugs
  • Extradural tumor in contact with the spinal cord or tumor located where swelling in response to therapy may impinge upon spinal cord
  • Subject has any of following laboratory abnormalities:
    • Platelets < 125,000/L;
    • WBC < 3000/L;
    • ANC < 1500/L;
    • Hemoglobin < 8 g/dL;
    • Estimated glomerular filtration rate < 30 mL/min/1.73 m2;
    • ALT > 3 x ULN ;
    • Bilirubin > 1.5 x ULN
  • Chronic immunosuppressive and/or full-dose anticoagulant therapy
  • Anti-platelet therapy, except low-dose aspirin for cardioprotection
  • PTT > ULN
  • INR > ULN
  • Radiation therapy, chemotherapy, immunotherapy, investigational therapy or corticosteroid use within 4 weeks of or after eligibility-defining bone marrow biopsy. Bisphosphonates and denosumab are permitted if subject has been receiving for at least 90 days
  • History of hypersensitivity to iodine
  • Any other concomitant serious illness or organ system dysfunction in opinion of Investigator would either compromise subject safety or interfere with test drug safety evaluation
  • Major surgery within 6 weeks of enrollment
  • Known history of HIV, hepatitis C or hepatitis B infection
  • Pregnancy or breast-feeding

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

Redlands Community Hospital

Redlands, CA

Mayo Clinic (Jacksonville)

Jacksonville, FL

Loyola University Medical Center
Cardinal Bernardin Cancer Center

Maywood, IL

Northwestern Medicine Cancer Center Warrenville

Warrenville, IL

Ochsner Medical Center

Jefferson, LA

University of Rochester Medical Center
James P. Wilmot Cancer Center

Rochester, NY

Greenville Memorial Hospital
Greenville Health System

Greenville, SC

California
Redlands Community Hospital

Redlands, CA

Florida
Mayo Clinic (Jacksonville)

Jacksonville, FL

Illinois
Loyola University Medical Center
Cardinal Bernardin Cancer Center

Maywood, IL

Northwestern Medicine Cancer Center Warrenville

Warrenville, IL

Kansas
Louisiana
Ochsner Medical Center

Jefferson, LA

New York
University of Rochester Medical Center
James P. Wilmot Cancer Center

Rochester, NY

South Carolina
Greenville Memorial Hospital
Greenville Health System

Greenville, SC

Washington
Wisconsin

Resources