Isatuximab in Treating Patients With High Risk Smoldering Plasma Cell Myeloma
|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: NCT02960555|
Recruitment Status : Recruiting
First Posted : November 9, 2016
Last Update Posted : December 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Smoldering Plasma Cell Myeloma||Biological: Isatuximab Other: Laboratory Biomarker Analysis||Phase 2|
I. To determine the rate of response according to the International Myeloma Working Group Criteria.
I. To determine progression free survival (PFS) at 2 years. II. To determine overall survival (OS). III. To determine duration of response (DOR). IV. To determine the clinical benefit rate (CBR). V. To evaluate safety of single agent treatment in this population. VI. To evaluate the immunogenicity of isatuximab.
Patients receive isatuximab intravenously (IV) over 5 hours on day 1 of course 1, and over 3 hours thereafter on days 8, 15, and 22 of course 1, on days 1 and 15 of courses 2-6, and on day 1 of subsequent courses. Treatment repeats every 28 days for up to 30 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)|
|Estimated Enrollment :||61 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Single Arm Trial of Isatuximab (SAR650984) in Patients With High Risk Smoldering Multiple Myeloma|
|Actual Study Start Date :||February 8, 2017|
|Estimated Primary Completion Date :||February 1, 2022|
|Estimated Study Completion Date :||February 1, 2022|
Experimental: Treatment (isatuximab)
Patients receive isatuximab IV over 5 hours on day 1 of course 1, and over 3 hours thereafter on days 8, 15, and 22 of course 1, on days 1 and 15 of courses 2-6, and on day 1 of subsequent courses. Treatment repeats every 28 days for up to 30 courses in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
- Overall response (>= partial response) [ Time Frame: 6 months ]The trial will be conducted by the Simon's optimal two-stage design and the response rate will be estimated accordingly. Summary statistics will be provided for continuous variables. Frequency tables will be used to summarize categorical variables. Logistic regression will be utilized to assess the effect of patient prognostic factors on the response rate and the adverse event rate.
- Progression free survival [ Time Frame: 2 years ]Will be estimated using the method of Kaplan and Meier. Comparison of time-to-event endpoints by important subgroups will be made using the log-rank test.
- Overall survival [ Time Frame: Up to 5 years ]Will be estimated using the method of Kaplan and Meier. Comparison of time-to-event endpoints by important subgroups will be made using the log-rank test.
- Incidence of adverse events [ Time Frame: Up to 5 years ]Adverse events will be summarized by frequency tables for all patients. For the safety endpoint, per-treated analysis will be performed to include any patient who received the treatment regardless of the eligibility nor the duration or dose of the treatment received.
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): NCT02960555
|Contact: Elisabet Manasanchfirstname.lastname@example.org|
|United States, New York|
|Mount Sinai Hospital||Recruiting|
|New York, New York, United States, 10029|
|Contact: Sundar Jagannath 212-241-7873|
|Principal Investigator: Sundar Jagannath|
|Memorial Sloan Kettering Cancer Center||Not yet recruiting|
|New York, New York, United States, 10065|
|Contact: Carl O. Landgren 212-639-5153|
|Principal Investigator: Carl O. Landgren|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Elisabet E. Manasanch 713-792-2860|
|Principal Investigator: Elisabet E. Manasanch|
|Principal Investigator:||Elisabet Manasanch||M.D. Anderson Cancer Center|