Pembrolizumab in Treating Patients With Intermediate or High-Risk Smoldering Multiple Myeloma
|ClinicalTrials.gov Identifier: NCT02603887|
Recruitment Status : Active, not recruiting
First Posted : November 13, 2015
Results First Posted : March 20, 2020
Last Update Posted : March 20, 2020
|Condition or disease||Intervention/treatment||Phase|
|Smoldering Plasma Cell Myeloma||Other: Laboratory Biomarker Analysis Biological: Pembrolizumab||Early Phase 1|
I. To determine the overall response rate after 8 cycles of treatment according to the International Myeloma Working Group Criteria (IMWG).
I. To determine time to progression to multiple myeloma (TTP) at 30 months from study entry.
II. To determine overall survival (OS). III. To determine duration of response (DOR). IV. To determine the clinical benefit rate (CBR) after 8 cycles of treatment according to the modified IMWG Criteria for multiple myeloma (MM).
V. To evaluate safety and tolerability of single agent treatment in this population.
I. Rate of minimal residual disease (MRD) negativity at complete remission (CR).
II. Molecular profiling (including whole exome sequencing and gene expression profiling) and cellular (including flow cytometry) profiling at baseline and/or at progression using bone marrow aspirate samples and peripheral blood.
III. Immunophenotypic characterization of dendritic, T-, B-, natural killer (NK)- and natural killer T (NKT)-cells, and inhibitory/activation markers on tumor cells at baseline and at completion of 8 cycles of therapy in bone marrow aspirate samples and/or peripheral blood.
IV. Evaluation of changes in PD-L1 and PD-1 expression at baseline/end of 8 cycles of treatment and correlate with clinical response.
Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 21 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6-12 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Single Arm, Single Center, Open Label Trial of Pembrolizumab in Patients With Intermediate and High Risk Smoldering Multiple Myeloma|
|Actual Study Start Date :||July 20, 2016|
|Actual Primary Completion Date :||December 30, 2017|
|Estimated Study Completion Date :||July 30, 2021|
Experimental: Treatment (pembrolizumab)
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
- Overall Response Rate (ORR) [ Time Frame: From cycle 1 to cycle 8, up to 168 days ]Overall response rate is defined as patients who have achieved partial response or higher as described per IMWG criteria for multiple myeloma after 8 cycles of therapy with pembrolizumab. Will be measured according to International Myeloma Working Group Criteria (IMWG) criteria. Response rate will be estimated accordingly. Each cycle has a duration of 21 days.
- Number of Participants That Had Progression to Multiple Myeloma [ Time Frame: At 30 months from study entry ]Progressive disease assessed by IMWG criteria for multiple myeloma after 8 cycles of therapy with pembrolizumab.
- Clinical Benefit Rate [ Time Frame: From cycle 1 to cycle 8, up to 168 days ]Minor response or better assessed by IMWG criteria for multiple myeloma after 8 cycles of therapy with pembrolizumab
- Overall Survival [ Time Frame: Time of start of treatment to death from any cause up to 2 years and 6 months ]Participants in a study or treatment group who are still alive for a certain period of time after they were diagnosed with or started treatment for a disease
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02603887
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Elisabet E Manasanch||M.D. Anderson Cancer Center|