Lenalidomide and Nivolumab in Treating Patients With Relapsed or Refractory Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT03333746|
Recruitment Status : Recruiting
First Posted : November 7, 2017
Last Update Posted : July 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Plasma Cell Myeloma Refractory Plasma Cell Myeloma||Other: Laboratory Biomarker Analysis Drug: Lenalidomide Biological: Nivolumab Other: Pharmacological Study||Phase 2|
I. To determine the efficacy of nivolumab in combination with lenalidomide (Revlimid) in terms of overall response rate in patients with relapse/refractory multiple myeloma (MM).
Patients receive lenalidomide orally (PO) on days 1-21 and nivolumab intravenously (IV) over 1 hour on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Lenalidomide in Combination With Nivolumab In Patients With Relapsed/Refractory Multiple Myeloma|
|Actual Study Start Date :||March 21, 2018|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: Treatment (lenalidomide, nivolumab)
Patients receive lenalidomide PO on days 1-21 and nivolumab IV over 1 hour on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
- ORR (Overall Response Rate) [ Time Frame: Up to 12 months ]Will be assessed by IMWG response criteria. 95% binomial confidence intervals will also be calculated for the estimate of the proportion of responses.
- Overall survival (OS) [ Time Frame: Up to 3 years ]Will evaluate other clinical outcomes using the methods of Kaplan-Meier.
- Progression free survival (PFS) [ Time Frame: Time from study entry until disease progression or death at trial closure for the per protocol population, assessed up to 3 years ]Will evaluate other clinical outcomes using the methods of Kaplan-Meier.
- Time to progression (TTP) [ Time Frame: Time from start of treatment until the date he or she has progression or dies, assessed up to 3 years ]Will be assessed.
- Immunomonitoring of lymphocytes subsets including natural killer (NK) cell [ Time Frame: Up to 3 years ]Will be explored using graphical analyses as well as summarized quantitatively.
- Immunomonitoring of lymphocytes subsets including T cell [ Time Frame: Up to 3 years ]Will be explored using graphical analyses as well as summarized quantitatively.
- Pharmacokinetics: The Maximum Plasma Concentration (Cmax) [ Time Frame: Screening, days 1 and 14 of each cycle ]Will be assessed using Cmax for Nivolumab in combination with lenalidomide
- Pharmacodynamics Profiles:Time to Maximum Plasma Concentration (Tmax) [ Time Frame: Screening, days 1 and 14 of each cycle ]Will be assessed using Tmax for Nivolumab in combination with lenalidomide
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): NCT03333746
|Contact: The Ohio State University Comprehensive Cancer Center||800-293-5066||OSUCCCClinicaltrials@osumc.edu|
|Contact: Cassidy Clark||614-688-8821||Cassidy.Clark@osumc.edu|
|United States, Ohio|
|Ohio State University Comprehensive Cancer Center||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Yvonne A. Efebera, MD 614-293-2268 firstname.lastname@example.org|
|Contact: Misty Fleming 614-688-9498 email@example.com|
|Principal Investigator: Yvonne A. Efebera, MD|
|Principal Investigator:||Yvonne Efebera, MD||Ohio State University Comprehensive Cancer Center|