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

Prisma Health - Greenville Memorial Hospital

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
Prisma Health - Greenville Memorial Hospital

Greenville, SC

Washington
Wisconsin

Resources