Lenalidomide and Pidilizumab in Treating Patients With Relapsed or Refractory Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT02077959|
Recruitment Status : Active, not recruiting
First Posted : March 4, 2014
Last Update Posted : December 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: lenalidomide Biological: pidilizumab Other: pharmacological study Other: laboratory biomarker analysis||Phase 1 Phase 2|
I. To determine the maximum tolerated dose (MTD), safety and efficacy of CT-011 (pidilizumab) in combination with lenalidomide (Revlimid) and assess efficacy in terms of overall response rate in patients with relapse/refractory multiple myeloma (MM).
OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.
Patients receive lenalidomide orally (PO) daily on days 1-21 and pidilizumab intravenously (IV) over 2 hours on day 3. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of Lenalidomide in Combination With Anti-PD-1 Monoclonal Antibody CT-011 in Patients With Relapsed/Refractory Multiple Myeloma|
|Actual Study Start Date :||March 3, 2014|
|Estimated Primary Completion Date :||June 30, 2018|
|Estimated Study Completion Date :||June 30, 2018|
Experimental: Treatment (lenalidomide, pidilizumab)
Patients receive lenalidomide PO daily on days 1-21 and pidilizumab IV over 1-2 hours on day 3. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other Name: CT-011
Other: pharmacological study
Other Name: pharmacological studies
Other: laboratory biomarker analysis
- MTD of pidilizumab combined with lenalidomide defined as the dose level at which no more than one of 6 patients experiences a dose-limiting toxicity (Phase I) [ Time Frame: 28 days ]
- Overall response rate in responding patients according to the IMWG response criteria (Phase II) [ Time Frame: Up to 30 days ]The proportion of responses (partial and complete) will be calculated out of all eligible patients who receive any treatment in that disease group who are included in the phase II assessment. Assuming the number of responses is binomially distributed, 95% binomial confidence intervals will also be calculated for the estimate of the proportion of responses.
- Time to progression [ Time Frame: Time from start of treatment until progression or death, assessed up to 30 days ]
- Overall survival (Phase II) [ Time Frame: Time from start of treatment to the date of his or her death, assessed up to 30 days ]OS will be evaluated using the methods of Kaplan-Meier.
- Pharmacokinetic parameters of pidilizumab in combination with lenalidomide [ Time Frame: Baseline, immediately at the end of infusion, 1, 24, 72, 168, and 336 hours, and just prior to course 2 ]
- Assess CT-011 Immunogenicity of pidilizumab [ Time Frame: Up to 30 days ]
- Assess Immunomonitoring of lymphoctes to includeT and NK cell subsets [ Time Frame: Up to 30 days ]Extensive immunomonitoring of T and NK cell subsets at baseline and upon completion of each 28-d cycle of therapy will be conducted.
- Ex-vivo assessment of immune functional activities [ Time Frame: Up to 30 days ]
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): NCT02077959
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|United States, Ohio|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Yvonne Efebera||Ohio State University Comprehensive Cancer Center|