Elotuzumab and Lenalidomide After Stem Cell Transplant in Treating Patients With Newly Diagnosed Multiple 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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02420860|
Recruitment Status : Active, not recruiting
First Posted : April 20, 2015
Last Update Posted : October 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hematopoietic Cell Transplantation Recipient Plasma Cell Myeloma||Biological: Elotuzumab Drug: Lenalidomide Other: Questionnaire Administration||Phase 2|
I. Establish activity of elotuzumab and lenalidomide in the maintenance setting post autologous stem cell transplant (ASCT) in myeloma patients.
II. Progression free survival (PFS).
I. Progression free survival 2. II. Overall survival. III. Determine incidence of secondary primary malignancy. IV. Evaluate the best response rate (stringent complete response [sCR]/very good partial response [VGPR]/partial response [PR]) based on International Myeloma Working Group (IMWG) criteria.
V. Evaluate time to progression. VI. Evaluate time to next therapy. VII. Evaluate the tolerability and toxicity. VIII. Perform MD Anderson Symptom Inventory (MDASI)-Myeloma symptom evaluation.
Patients receive elotuzumab intravenously (IV) over 2-4 hours on days 1, 8, 15, and 21 of courses 1-2 and on day 1 of each subsequent course. Patients also receive lenalidomide orally (PO) on days 1-28. 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 :||113 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of the Combination of Elotuzumab With Lenalidomide as Maintenance Therapy Post Autologous Stem Cell Transplant in Patients With Multiple Myeloma|
|Actual Study Start Date :||April 14, 2015|
|Estimated Primary Completion Date :||April 30, 2024|
|Estimated Study Completion Date :||April 30, 2024|
Experimental: Treatment (elotuzumab, lenalidomide)
Patients receive elotuzumab IV over 2-4 hours on days 1, 8, 15, and 21 of courses 1-2 and on day 1 of each subsequent course. Patients also receive lenalidomide PO on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: Questionnaire Administration
- Progression free survival [ Time Frame: The time from autologous stem cell transplantation to the time of clinical progression, death, whichever occurs first or the time of last contact, assessed up to 48 months ]Will be estimated using the Kaplan-Meier method. The log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model may be used to include multiple covariates in the time-to-event analysis.
- Response rate [ Time Frame: Up to 48 months ]Estimated along with 95% confidence intervals.
- Incidence of new primary malignancy [ Time Frame: Up to 48 months ]Estimated along with 95% confidence intervals.
- Overall survival [ Time Frame: Up to 48 months ]Will be estimated using the Kaplan-Meier method. The log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model may be used to include multiple covariates in the time-to-event analysis.
- Incidence of toxicity [ Time Frame: Up to 48 months ]Toxicity data will be summarized by frequency tables. Per-treated analysis will be used to include any patient who received the treatment regardless of the eligibility nor the duration or dose of the treatment received. The intensity (severity) of adverse events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.
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): NCT02420860
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Sheeba Thomas||M.D. Anderson Cancer Center|