A Study of Elotuzumab With Pomalidomide, Bortezomib, and Dexamethasone in Relapsed Multiple Myeloma

NCT02718833 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: 15-475
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 6

Brief Summary

This research study is studying a combination of study drugs as a possible treatment for relapsed and refractory Multiple Myeloma. The interventions involved in this study are elotuzumab, pomalidomide, bortezomib, dexamethasone.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; Relapse

Outcome Measures

Primary Outcomes (2)

• Overall response rate by International Myeloma Working Group criteria.

  To evaluate the objective response rate (partial response or better) of elotuzumab in combination with pomalidomide, bortezomib, and dexamethasone in patients with relapsed and refractory multiple myeloma and who have received at least two prior therapies and are relapsed and/or refractory to both lenalidomide and bortezomib.

  2 years

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  2 years

Secondary Outcomes (1)

• Progression Free Survival

  2 Years

Study Arms (1)

Elotuzumab, pomalidomide, bortezomib, dex

EXPERIMENTAL

Each cycle is 28 days. Elotuzumab will be administered by intravenous infusion. For cycles 1-2, elotuzumab will ge given weekly. For cycles 3-8, elotuzumab will be given every other week. For cycles 9+, elotuzumab will be given on day 1. Pomalidomide will be given orally on days 1-21. Bortezomib will be given weekly subcutaneously on days 1, 8, 15. Dexamethasone will be given as a combination orally and intravenously.

Drug: Elotuzumab; Drug: Pomalidomide; Drug: Bortezomib; Drug: Dexamethasone

Interventions

Pomalidomide DRUG

Also known as: Pomalyst

Elotuzumab, pomalidomide, bortezomib, dex

Bortezomib DRUG

Also known as: Velcade

Elotuzumab, pomalidomide, bortezomib, dex

Dexamethasone DRUG

Also known as: Decadron

Elotuzumab, pomalidomide, bortezomib, dex

Elotuzumab DRUG

Also known as: Empliciti

Elotuzumab, pomalidomide, bortezomib, dex

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All laboratory assessments should be performed within 21 days of initiation of protocol therapy unless otherwise specified.
• Participant has given voluntary signed written informed consent before performance of any study-related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (see Appendix A).
• Age ≥ 18 years
• Measurable disease of multiple myeloma as defined by at least one of the following
• Serum monoclonal protein ≥ 0.5 g/dL
• ≥ 200 mg of monoclonal protein in the urine on 24 hour electrophoresis
• Serum free light chain ≥ 100 mg/L (10 mg/dL) and abnormal serum free kappa to serum free kappa light chain ratio
• Previously treated relapsed and refractory multiple myeloma
• Patients must have received at least one prior therapy with at least 2 cycles of lenalidomide and at least 2 cycles of a proteasome inhibitor (either in separate regimens or within the same regimen)
• Disease progression on or within 60 days of completion of last therapy.
• ANC ≥ 1000/μL. G-CSF is not permitted within 14 days of screening.
• Platelet count ≥ 50,000/µL. Platelet transfusion is not permitted within 7 days of screening.
• Hemoglobin ≥ 8 g/dL. Red blood cell transfusions are permitted to meet eligibility criteria.
• Calculated creatinine clearance of ≥ 30 mL/min according to Cockcroft-Gault equation

You may not qualify if:

• Prior therapy with elotuzumab
• Participants who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier. Patients may have received dexamethasone within 2 weeks prior to entering study.
• Participants who are receiving any other investigational agents.
• Concomitant high dose corticosteroids except patients may be on chronic steroids (maximum dose 10 mg/day prednisone equivalent) if they are being given for disorders other than myeloma, e.g. adrenal insufficiency, rheumatoid arthritis, etc.
• Pregnant or lactating females
• Prior history of malignancies, other than MM, unless the patient has been free of the disease for ≥ 3 years. Exceptions include the following:
• Basal or squamous cell carcinoma of the skin
• Carcinoma in situ of the cervix
• Ductal carcinoma in situ of the breast
• Incidental histologic finding of prostate cancer (T1a or T1b)
• Another malignancy undergoing active treatment with the exception of non-melanoma skin cancer or in situ cervical cancer.
• Patients with plasma cell leukemia, POEMS syndrome, or amyloidosis are excluded from this trial.
• HIV infection
• Active hepatitis B infection or active hepatitis C infection. Participants who have prior hepatitis C infection but who have received an antiviral treatment and show no detectable viral RNA for 6 months are eligible.
• Peripheral neuropathy ≥ grade 2 despite supportive therapy.

Sponsors & Collaborators

• Multiple Myeloma Research Consortium: collaborator
• Celgene: collaborator
• Bristol-Myers Squibb: collaborator
• Massachusetts General Hospital: lead

Study Sites (6)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Mass General/North Shore Cancer Center

Danvers, Massachusetts, 01923, United States

Location

Newton-Wellesley Hospital

Newton, Massachusetts, 02462, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Related Publications (2)

• Yee AJ, Laubach JP, Campagnaro EL, Lipe BC, Nadeem O, Friedman RS, Cole CE, O'Donnell EK, Bianchi G, Branagan AR, Schlossman RL, Shapiro SJ, Harrington CC, Burke JN, Gammon MT, Lively KJ, Reimonn CA, Andrade DX, Redd R, Lohr JG, Anderson KC, Richardson PG, Raje NS. Elotuzumab in combination with pomalidomide, bortezomib, and dexamethasone in relapsed and refractory multiple myeloma. Blood Adv. 2025 Mar 11;9(5):1163-1170. doi: 10.1182/bloodadvances.2024014717.

  PMID: 39626297 DERIVED

• Waldschmidt JM, Yee AJ, Vijaykumar T, Pinto RA, Frede J, Anand P, Bianchi G, Guo G, Potdar S, Seifer C, Nair MS, Kokkalis A, Kloeber JA, Shapiro S, Budano L, Mann M, Friedman R, Lipe B, Campagnaro E, O'Donnell EK, Zhang CZ, Laubach JP, Munshi NC, Richardson PG, Anderson KC, Raje NS, Knoechel B, Lohr JG. Cell-free DNA for the detection of emerging treatment failure in relapsed/ refractory multiple myeloma. Leukemia. 2022 Apr;36(4):1078-1087. doi: 10.1038/s41375-021-01492-y. Epub 2022 Jan 13.

  PMID: 35027656 DERIVED

MeSH Terms

Conditions

Multiple Myeloma; Recurrence

Interventions

elotuzumab; pomalidomide; Bortezomib; Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Andrew J Yee, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 11, 2016
• First Posted: March 24, 2016
• Study Start: June 21, 2016
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)