Elotuzumab and Lenalidomide After Stem Cell Transplant in Treating Patients With Newly Diagnosed Multiple Myeloma
Phase II Study of the Combination of Elotuzumab With Lenalidomide as Maintenance Therapy Post Autologous Stem Cell Transplant in Patients With Multiple Myeloma
Sponsor: M.D. Anderson Cancer Center
A observational or N/A phase clinical study on Hematopoietic Cell Transplantation Recipient and Plasma Cell Myeloma, this trial is ongoing. The trial is conducted by M.D. Anderson Cancer Center and has accumulated 22 data snapshots since 2015. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Study Description(click to expand)PRIMARY OBJECTIVES:
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).
SECONDARY OBJECTIVES:
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.
OUTLINE:
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.
PRIMARY OBJECTIVES:
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).
SECONDARY OBJECTIVES:
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.
OUTLINE:
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.
Status Flow
Change History
22 versions recorded-
Apr 16, 2026 — Present [daily]
Active Not Recruiting
Phase: PHASE2 → None
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Nov 2025 — Apr 2026 [monthly]
Active Not Recruiting PHASE2
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Jun 2025 — Nov 2025 [monthly]
Active Not Recruiting PHASE2
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Mar 2025 — Jun 2025 [monthly]
Active Not Recruiting PHASE2
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Sep 2024 — Mar 2025 [monthly]
Active Not Recruiting PHASE2
▶ Show 17 earlier versions
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Jul 2024 — Sep 2024 [monthly]
Active Not Recruiting PHASE2
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Mar 2024 — Jul 2024 [monthly]
Active Not Recruiting PHASE2
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Oct 2023 — Mar 2024 [monthly]
Active Not Recruiting PHASE2
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Sep 2022 — Oct 2023 [monthly]
Active Not Recruiting PHASE2
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Mar 2022 — Sep 2022 [monthly]
Active Not Recruiting PHASE2
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Jan 2021 — Mar 2022 [monthly]
Active Not Recruiting PHASE2
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Nov 2020 — Jan 2021 [monthly]
Active Not Recruiting PHASE2
Status: Recruiting → Active Not Recruiting
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Oct 2020 — Nov 2020 [monthly]
Recruiting PHASE2
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Sep 2020 — Oct 2020 [monthly]
Recruiting PHASE2
Status: Active Not Recruiting → Recruiting
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Mar 2020 — Sep 2020 [monthly]
Active Not Recruiting PHASE2
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Jul 2019 — Mar 2020 [monthly]
Active Not Recruiting PHASE2
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Apr 2019 — Jul 2019 [monthly]
Active Not Recruiting PHASE2
Status: Recruiting → Active Not Recruiting
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Nov 2018 — Apr 2019 [monthly]
Recruiting PHASE2
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Jun 2018 — Nov 2018 [monthly]
Recruiting PHASE2
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Jul 2017 — Jun 2018 [monthly]
Recruiting PHASE2
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Feb 2017 — Jul 2017 [monthly]
Recruiting PHASE2
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Jan 2017 — Feb 2017 [monthly]
Recruiting PHASE2
First recorded
Apr 2015
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
This phase II trial studies how well elotuzumab works when given with lenalidomide as maintenance therapy after transplant in patients with newly diagnosed multiple myeloma who underwent transplant using their own stem cells (autologous transplant). Maintenance therapy is treatment that is given to help keep cancer from coming back after it has disappeared following the initial treatment. Immunotherapy with monoclonal antibodies, such as elotuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Biological therapies, such as lenalidomide, may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Adding elotuzumab to standard maintenance therapy with lenalidomide may work better in treating patients with multiple myeloma who have undergone transplant.
Contact Information
- M.D. Anderson Cancer Center
- National Cancer Institute (NCI)
For direct contact, visit the study record on ClinicalTrials.gov .