Study of Pomalidomide to Evaluate the Pharmacokinetics and Safety for Patients With Multiple Myeloma and Impaired Renal Function (POM Renal)

Official Title

A Phase 1 Multi-Centre, Open-Label, Dose-Escalation Study to Determine the Pharmacokinetics and Safety of Pomalidomide When Given in Combination With Low Dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma and Impaired Renal Function

Summary:

The purpose of this study is to determine the pharmacokinetics (PK) and safety for the combination of pomalidomide (POM) + low-dose dexamethasone (LD-DEX) in subjects with relapsed or refractory Multiple Myeloma (RRMM) and impaired renal function.

Trial Description

Primary Outcome:

  • PK-Area under the plasma concentration time curve (AUC)
  • PK-Time to maximum plasma concentration (Cmax)
  • PK-Apparent total body clearance (CL/F)
  • PK-Renal clearance (CLr)
  • PK-Apparent volume of distribution (V/F)
  • PK-Effective terminal half-life (T1/2)
Secondary Outcome:
  • Number of participants with adverse events (AEs)
  • Number of participants alive
  • Time to response
  • Duration of response
The primary objective of the study is to determine the PK and safety for the combination of POM + (LD-DEX) in subjects with RRMM and impaired renal function. The secondary objective of the study is to evaluate the efficacy of POM + (LD_DEX) in subjects with RRMM and impaired renal function. This is a 3+3 dose escalation design, with one cohort each for patients with severely impaired renal function patients (CrCl < 30 mL/min) requiring and not requiring dialysis respectively. There will also be one control cohort with normal renal function, these patients will receive 4 mg POM. Dosing will be 21 days out of a 28 day cycle.

View this trial on ClinicalTrials.gov

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.

Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society