Alternating Ixazomib Citrate and Lenalidomide as Maintenance Therapy After Stem Cell Transplant in Treating Patients With Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT02619682|
Recruitment Status : Recruiting
First Posted : December 2, 2015
Last Update Posted : January 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Plasma Cell Myeloma Transplant-Related Carcinoma||Drug: Ixazomib Citrate Other: Laboratory Biomarker Analysis Drug: Lenalidomide||Phase 2|
I. Evaluate the toxicity of the use of ixazomib (ixazomib citrate) and lenalidomide as maintenance therapy after autologous transplant.
I. Evaluate the ability to deliver the planned therapy.
II. Assess initial response to therapy.
III. Evaluate the median time to disease progression.
IV. Assess overall survival.
Within 30-120 days after completion of autologous transplant, patients receive ixazomib citrate orally (PO) on days 1, 8 and 15 every 28 days for 2 courses, followed by lenalidomide PO once daily (QD) on days 1-28 for 2 courses. Treatment repeats, alternating after every 2 courses, for up to 24 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and then every 3 months for 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Alternating the Administration of Ixazomib and Lenalidomide as Maintenance Therapy After Autologous Transplant for Treating Multiple Myeloma|
|Actual Study Start Date :||December 30, 2015|
|Estimated Primary Completion Date :||December 2020|
Experimental: Treatment (ixazomib citrate and lenalidomide)
Within 30-120 days after finishing autologous transplant, patients receive ixazomib citrate PO on days 1, 8 and 15. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients then receive lenalidomide PO QD on days 1-28. Treatment repeats for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients will continue to alternate between ixazomib citrate and lenalidomide every 2 courses for up to 24 months in the absence of disease progression or unacceptable toxicity.
Drug: Ixazomib Citrate
Other: Laboratory Biomarker Analysis
- Incidence of adverse events, graded according to Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: 4 months ]The first four months of therapy will be used as the time period in which toxicity will be evaluated and stopping rules for unacceptable toxicity will be implemented. A true withdrawal rate within first 4 months of 15% will be considered excessive. The incidence of second cancers will also be collected.
- Overall survival [ Time Frame: Up to 2 years post-treatment ]
- Time to disease progression [ Time Frame: Up to 2 years post-treatment ]Response criteria will be determined by International Myeloma Working Group Criteria. In patients with chemo-refractory disease at the time of ASCT, the therapy will be felt to be promising if median time to progression is > 9 months. If chemo-sensitive disease at time of ASCT, the therapy will be felt to be promising if median time to progression is > 41 months based on Cancer and Leukemia Group B (CALGB) 10014 lenalidomide maintenance study post ASCT. Initial response rates and outcome will be descriptively reported.
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): NCT02619682
|United States, Washington|
|Fred Hutchinson Cancer Research Center||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Leona A. Holmberg 206-667-6447 email@example.com|
|Principal Investigator: Leona A. Holmberg|
|Principal Investigator:||Leona Holmberg||Fred Hutch/University of Washington Cancer Consortium|