Pomalidomide, Ixazomib Citrate, and Dexamethasone in Treating Patients With Previously Treated Multiple Myeloma or Plasma Cell Leukemia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02547662|
Recruitment Status : Recruiting
First Posted : September 11, 2015
Last Update Posted : August 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Plasma Cell Leukemia Plasma Cell Myeloma Plasmacytoma||Drug: Dexamethasone Drug: Ixazomib Citrate Other: Laboratory Biomarker Analysis Drug: Pomalidomide||Phase 2|
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.
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.
I. To assess the proportion of patients achieving minimal residual disease (MRD) negative status.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Trial of Pomalidomide, Ixazomib and Dexamethasone in Patients With Multiple Myeloma With Extramedullary Disease or Plasma Cell Leukemia|
|Actual Study Start Date :||December 24, 2015|
|Estimated Primary Completion Date :||December 15, 2020|
|Estimated Study Completion Date :||December 15, 2020|
Experimental: Treatment (ixazomib citrate, pomalidomide, dexamethasone)
Patients receive ixazomib citrate 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.
Drug: Ixazomib Citrate
Other: Laboratory Biomarker Analysis
- 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 (PR), 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.
- 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 versus (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 National Cancer Institute Common Terminology Criteria for Adverse Events 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.
- Proportion of patients who achieve minimal residual disease (MRD) negative status [ Time Frame: Up to 5 years ]The proportion of patients who achieve MRD negative status will be estimated by the number of patients who are MRD negative divided by the total number of evaluable patients who achieve a sCR or CR. Exact binomial 95% confidence intervals for the true MRD negative rate will be calculated.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02547662
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Clinical Trials Referral Office 855-776-0015|
|Principal Investigator: Shaji K. Kumar|
|United States, Tennessee|
|Sarah Cannon Cancer Center||Recruiting|
|Nashville, Tennessee, United States, 37203|
|Contact: Jessica L. Piggee 615-329-6838 Jessica.email@example.com|
|Principal Investigator: Jesus G. Berdeja|
|Principal Investigator:||Shaji Kumar||Mayo Clinic|