TheranosticTrials.org

Clinical Trial · NCT02998047

A Phase I Study of Lintuzumab-Ac225 in Patients With Refractory Multiple Myeloma

Overview

1. Establish the MTD of Lintuzumab-Ac225 as monotherapy 2. Establish overall response rate (ORR) where ORR = CR + sCR+ VGPR+PR) 3. Confirm the safety profile of the treatment regimen 4. Estimate progression-free survival (PFS) and overall survival

Sponsor

Actinium Pharmaceuticals, Inc

Phase

Phase 1

Contacts

Avinash Desai, MD (STUDY_DIRECTOR)

ClinicalTrials.gov

NCT02998047

Eligibility

Inclusion

  • Myocardial infarction, uncontrolled angina within 6 months, congestive heart failure, or cardiomyopathy.
  • Active serious infections uncontrolled by antibiotics
  • Confirmed diagnosis of multiple myeloma with measurable disease, as defined by the presence of M immunoglobulin protein in serum electrophoresis of at least 0.5 g/dL for IgG or 0.5 g/dL for IgA or urinary excretion of at least 200 mg monoclonal light chain per 24 hours.
  • Clinically significant pleural effusion in the previous 12 months or current ascites.
  • Presence of HAHA on screening
  • Greater than 25% of myeloma plasmocytes from bone marrow must be CD33 positive.
  • Treatment with chemotherapy or biological therapy 3 weeks prior to enrollment;
  • Symptomatic spinal cord compression; .
  • Serum potassium and magnesium levels within institutional normal limits. Total serum calcium or ionized calcium level must be greater than or equal to the lower limit of normal.
  • All acute toxicities from any prior therapy (radiotherapy, chemotherapy, or surgical procedures) resolved to Grade ≤ 2, NCI CTCAE.
  • Clinically-significant coagulation or platelet function disorder (eg, known von Willebrand's disease).
  • Concomitant therapy with bisphosphonates.
  • Men whose sexual partners are WOCBP, who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least six months (6 months) after completion of study medication.
  • Clinically significant pulmonary disease
  • Women who are pregnant or breastfeeding
  • Women with a positive pregnancy test on enrollment or prior to investigational product administration.
  • Pathological fracture within 3 months prior to treatment;
  • Medical History and Concurrent Diseases
  • Inclusion Criteria-
  • Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2Exclusion Criteria-
  • Required baseline laboratory data including: White blood cell count, Absolute neutrophil count (ANC), Platelets, Hemoglobin, Serum creatinine, AST, Creatinine clearance, Bilirubin , AST and ALT , FEV1/FVC
  • Clinical diagnosis of multiple myeloma requiring treatment that has relapsed after or proven refractory to at least three prior treatment regimens, and in the opinion of the investigator must not be candidates for any FDA approved drug known to provide clinical benefit.
  • Prisoners or subjects who are involuntarily incarcerated.
  • Treatment with radiation within 6 weeks
  • Concurrent therapy with any other investigational agent.
  • Abnormal QTc interval prolonged (\> 450 msec) after electrolytes have been corrected on baseline ECG.
  • Prior treatment with radiation to cumulative maximum tolerated dose
  • Allergies and Adverse Drug Reactions o Intolerance to humanized monoclonal antibodies
  • Other Exclusion Criteria
  • Clinically significant cardiac disease (NYHA Class III or IV) including preexisting arrhythmia (such as ventricular tachycardia, ventricular fibrillation, or "Torsade de Pointes")
  • Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
  • Women of child bearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least one month (4 weeks) before and for at least six months (6 months) after the last dose of study medication.
  • Physical and Laboratory Test Findings o Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality, serious uncontrolled medical disorder or active infection that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for this study.
  • Sex and Reproductive Status
  • Target Disease Exceptions

Exclusion

  • No bone marrow transplant within 3 months prior to treatment initiation