NCT02655458

Phase 1 Study of Elotuzumab in Combination With Autologous Stem Cell Transplantation and Lenalidomide Maintenance for Multiple Myeloma

Completed Phase 1 Last updated 15 August 2017

What this trial tests

Phase 1 trial testing Elotuzumab in Multiple Myeloma in 15 participants. Completed in 13 July 2017.

Timeline

1 January 2016

Primary endpoint
13 July 2017

13 July 2017

Quick facts

Lead sponsor	Hearn Jay Cho
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	1 January 2016
Primary completion	13 July 2017
Estimated completion	13 July 2017
Sites	1 location across United States

Drugs / interventions tested

• Elotuzumab (elotuzumab) — full drug profile →
• Lenalidomide — full drug profile →
• autologous PBMC reconstitution
• ASCT — full drug profile →

Conditions studied

• Multiple Myeloma — all drugs for Multiple Myeloma →

Sponsor

Hearn Jay Cho

Who can join

18 and older, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Incidence of completion of treatment
  Time frame: up to 24 months
  Safety and tolerability will be measured by the number of evaluable patients who complete the treatment protocol.

Sponsor's own description

The purpose of this study is to explore the combination of Elotuzumab in combination with autologous stem cell transplantation and lenalidomide maintenance to see what side effects it may have and how well it works for the treatment of symptomatic multiple myeloma diagnosed and treated with induction therapy in the past year.

Induction therapy is the first phase of treatment for multiple myeloma. The goal of induction therapy for multiple myeloma is to reduce the number of plasma cells in the bone marrow and the proteins that the plasma cells produce. Induction therapy is usually given for 3-4 weeks.

An autologous peripheral blood stem cell transplant is a procedure in which immature "stem cells" are collected and stored for future use. A high dose of chemotherapy is given to the patient to destroy myeloma cells, and the patient's stem cells are replaced.

The investigational drug in this program is elotuzumab. Elotuzumab is known as BMS-901608. Elotuzumab is a manufactured protein directed against a target found on multiple myeloma cells. Lenalidomide is currently approved for patients with multiple myeloma. Melphalan and cyclophosphamide, the drugs used during stem cell collection and transplant, are also approved by the U.S. FDA. Melphalan is an FDA-approved chemotherapy for multiple myeloma and is used as high-dose treatment prior to stem cell transplantation. Cyclophosphamide is an FDA-approved chemotherapy that may be used, either alone, or in combination with other drugs to treat multiple myeloma.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Trial watch: Immunogenic cell death induction by anticancer chemotherapeutics.
   Garg AD, More S, Rufo N, Mece O, et al · · 2017 · cited 206× · PMID 29209573 · DOI 10.1080/2162402x.2017.1386829
2. Elotuzumab for the treatment of multiple myeloma.
   Wang Y, Sanchez L, Siegel DS, Wang ML. · · 2016 · cited 41× · PMID 27417553 · DOI 10.1186/s13045-016-0284-z
3. Posttransplant maintenance therapy in multiple myeloma: the changing landscape.
   Sengsayadeth S, Malard F, Savani BN, Garderet L, et al · · 2017 · cited 25× · PMID 28338672 · DOI 10.1038/bcj.2017.23
4. Clinical potential of SLAMF7 antibodies - focus on elotuzumab in multiple myeloma.
   Friend R, Bhutani M, Voorhees PM, Usmani SZ. · · 2017 · cited 15× · PMID 28356715 · DOI 10.2147/dddt.s98053
5. Phase 1 study combining elotuzumab with autologous stem cell transplant and lenalidomide for multiple myeloma.
   Coffey DG, Osman K, Aleman A, Bekri S, et al · · 2024 · cited 4× · PMID 38609316 · DOI 10.1136/jitc-2023-008110
6. Elotuzumab as a novel anti-myeloma immunotherapy.
   Radhakrishnan SV, Bhardwaj N, Steinbach M, Weidner J, et al · · 2017 · cited 3× · PMID 28604269 · DOI 10.1080/21645515.2017.1327487
7. SLAMF receptors: key regulators of tumor progression and emerging targets for cancer immunotherapy.
   Li J, Fan T, Wang D, Xiao C, et al · · 2025 · cited 2× · PMID 40382610 · DOI 10.1186/s12943-025-02308-8
8. Treatment Strategy for Ultra-High-Risk Multiple Myelomas with Chromosomal Aberrations Considering Minimal Residual Disease Status and Bone Marrow Microenvironment.
   Suzuki K, Yano S. · · 2023 · cited 1× · PMID 37173885 · DOI 10.3390/cancers15092418