Clinical Trial: Pomalidomide, Ixazomib Citrate, and Dexamethasone in Treating Patients With Previously Treated Multiple Myeloma or Plasma Cell Leukemia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Phase 2 Trial of Pomalidomide, Ixazomib and Dexamethasone in Patients With Multiple Myeloma With Extramedullary Disease or Plasma Cell Leukemia

Brief Summary: This phase II trial studies how well pomalidomide, ixazomib citrate, and dexamethasone work in treating patients with previously treated multiple myeloma or plasma cell leukemia. Biological therapies, such as pomalidomide and dexamethasone, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving pomalidomide, ixazomib citrate, and dexamethasone together may be more effective in treating multiple myeloma.

Detailed Summary:

PRIMARY OBJECTIVES:

I. To determine the confirmed response rate (>= partial response [PR]) of ixazomib citrate (ixazomib), used in combination with pomalidomide and dexamethasone in patients with previously treated multiple myeloma (MM) with extramedullary disease.

SECONDARY OBJECTIVES:

I. To determine the toxicities associated with ixazomib in combination with pomalidomide and dexamethasone in patients with previously treated MM with extramedullary disease.

II. To determine the differential response rates (biochemical versus extramedullary disease) with ixazomib in combination with pomalidomide and dexamethasone in patients with previously treated MM with extramedullary disease.

III. To determine the progression free survival following treatment with ixazomib in combination with pomalidomide and dexamethasone in patients with previously treated MM with extramedullary disease.

TERTIARY OBJECTIVES:

I. To assess the proportion of patients achieving minimal residual disease (MRD) negative status.

OUTLINE:

Patients receive ixazomib citrate orally (PO) on days 1, 8 and 15, pomalidomide PO on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 or 6 months for up to 3 years.


Sponsor: Mayo Clinic

Current Primary Outcome: Confirmed response rate [ Time Frame: Up to 5 years ]

A confirmed response is defined as a patient who has achieved a stringent complete response (sCR), complete response (CR), very good partial response, or PR on two consecutive evaluations. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Biochemical response, defined as a response by serum M-protein, urine M-protein, or serum free light chain (FLC) assay parameters [ Time Frame: Up to 5 years ]
    Type of response will be differentiated as biochemical vs. extramedullary disease. The biochemical response rate will be estimated by the number of responders divided by the number of evaluable patients who have measurable disease by serum M-protein, urine M-protein, or serum FLC assay at baseline. Exact binomial confidence intervals will be calculated.
  • Extramedullary response, defined as a response by extramedullary plasmacytoma or plasma cell count parameters [ Time Frame: Up to 5 years ]
    Type of response will be differentiated as biochemical vs. extramedullary disease. The extramedullary response rate will be estimated by the number of responders divided by the number of evaluable patients. Exact binomial confidence intervals will be calculated.
  • Incidence of adverse events graded according to the NCI CTCAE version 4.0 [ Time Frame: Up to 5 years ]
    The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration.
  • Progression-free survival [ Time Frame: Time from registration to the earliest date of documentation of disease progression or death due to any cause, assessed up to 5 years ]
    The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.


Original Secondary Outcome: Same as current

Information By: Mayo Clinic

Dates:
Date Received: September 10, 2015
Date Started: December 2015
Date Completion: December 2020
Last Updated: March 28, 2017
Last Verified: March 2017