Elotuzumab, Pomalidomide, & Dexamethasone (Elo-Pom-Dex) With Second Autologous Stem Cell Transplantation for Relapsed Multiple Myeloma

NCT03030261 | Active Not Recruiting Phase 2 Results DMC FDA Drug

• 3 other identifiers: 201701084CA204-225PO-CL-MM-PI-008341
• Study Type: interventional
• Target: 25
• Locations: 2 countries
• Sites: 3

Brief Summary

Based on the need to improve outcomes post second autologous stem cell transplant (ASCT) for multiple myeloma (MM) and the benefits seen of maintenance treatment following initial ASCT, the natural next step is to evaluate maintenance/continuation therapy following second ASCT. Pomalidomide is active against MM cells refractory to both bortezomib and lenalidomide, making it an ideal choice for continuation therapy following second ASCT. Adding elotuzumab may increase efficacy and also the durability of responses which is essential to improving outcomes following second ASCT.

Conditions

Multiple Myeloma in Relapse

Outcome Measures

Primary Outcomes (1)

• Event-free Survival (EFS) Rate

  -Event-free survival (EFS) will be defined as time from ASCT to disease progression, relapse, or death, whichever occurs first. Patients who are removed from study therapy prior to any of these events occurring will be censored at the time of initiation of subsequent anti-myeloma treatment.

  1 year

Secondary Outcomes (5)

• Overall Response Rate (ORR)

  1 year

• Complete Response Rate (CRR)

  1 year

• Progression-free Survival (PFS)

  Up to 5 years post completion of treatment

• Overall Survival (OS)

  Up to 5 years post completion of treatment

• Toxicity of Regimen as Measured by Number of Grade 3-5 Adverse Events

  Up to 30 days following completion of treatment (estimated to be 106 weeks)

Study Arms (1)

Elotuzumab + Pomalidomide + Dexamethasone

EXPERIMENTAL

* Patients will receive 2-6 cycles of salvage/induction per standard of care. After protocol version 02/13/2020, patients may have already received their induction therapy prior to enrolling in the study. * Following induction, patients will undergo standard of care ASCT melphalan conditioning (ASCT). Administration of melphalan and the second ASCT will be done as part of routine care and procedures are not dictated by this protocol. * Continuation therapy with Elo-Pom-Dex will begin between Days 80 and 120 following the second ASCT: * 10 mg/kg of elotuzumab on Days 1 and 15 for Cycles 1-6 followed by 20 mg/kg on Day 1 for Cycles 7+ * 2 mg pomalidomide daily on Days 1-21 of all cycles * 40 mg dexamethasone on Days 1 and 15 of all cycles for Cycles 1-6 followed by 40 mg on Day 1 for Cycles 7+ * Continuation therapy may continue until relapse or progression.

Drug: Elotuzumab; Drug: Pomalidomide; Drug: Dexamethasone

Interventions

Elotuzumab DRUG

During continuation therapy, elotuzumab will be administered on a 28-day cycle as follows: on Days 1 and 15 for Cycles 1-6 and on Day 1 for Cycles 7+. For Cycles 1-6 elotuzumab will be administered intravenously at a dose of 10 mg/kg. For Cycles 7+ elotuzumab will be administered at a dose of 20 mg/kg.

Also known as: Empliciti

Elotuzumab + Pomalidomide + Dexamethasone

Pomalidomide DRUG

During continuation therapy, pomalidomide will be taken by mouth daily on Days 1-21 of each 28-day cycle at a starting dose of 2 mg. During continuation, pomalidomide may be dose escalated to 4 mg at the discretion of the treating physician if the 2 mg dose is tolerated.

Also known as: Pomalyst

Elotuzumab + Pomalidomide + Dexamethasone

Dexamethasone DRUG

During continuation therapy, dexamethasone will be taken by mouth at a starting dose of 40 mg. It will be given on a 28-day cycle as follows: on Days 1 and 15 for Cycles 1-6 and on Day 1 only for Cycles 7+. Sufficient quantity of drug for one cycle of therapy will be prescribed to the patient at a time.

Also known as: Decadron

Elotuzumab + Pomalidomide + Dexamethasone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed diagnosis of multiple myeloma.
• Received prior autologous stem cell transplantation as first line therapy for multiple myeloma with subsequent disease relapse/progression.
• Failed 1 or 2 lines of treatment for multiple myeloma. A line of treatment includes all therapy including induction, transplant, and maintenance administered in a sequence in the absence of relapse/progression. Once relapse/progression occurs and subsequently the anti-myeloma treatment is changed, a new line of treatment has begun. Local radiation or corticosteroids will not be considered treatment for multiple myeloma.
• Received 2 to 6 cycles of induction therapy per standard of care prior to 2nd autologous stem cell transplantation
• Received standard of care melphalan conditioning for 2nd autologous stem cell transplantation, is currently Day +80 to +120 following transplant, and is responding to therapy (partial response or better as compared to pre-induction assessment.
• All US study participants must be registered into the mandatory POMALYST REMS® program and be willing and able to comply with the requirements of the POMALYST REMS® program. For Canadian sites, patients will followed according to the Pomalidomide pregnancy prevention program
• Females of reproductive potential within the US must agree to adhere to the scheduled pregnancy testing as required in the POMALYST REMS® program. For Canadian sites, patients will followed according to the Pomalidomide pregnancy prevention program
• At least 18 and no more than 75 years of age at enrollment.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
• Normal bone marrow and organ function as defined as ALL of the following:
• Absolute neutrophil count ≥ 1000/mm\^3
• Platelets ≥ 75,000/mm\^3 (transfusions not permitted within 7 days of screening)
• Total bilirubin ≤ 2.0 x institutional upper limit of normal (IULN)
• AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
• Creatinine clearance ≥ 15 mL/min

You may not qualify if:

• Refractory to elotuzumab and/or pomalidomide, defined as progressive disease or clinical relapse on therapy or within 60 days following completion of therapy. Prior exposure to elotuzumab and/or pomalidomide is allowed as long as patient is not refractory to these agents.
• More than one prior transplant prior to study entry with the exception of tandem transplantation. Tandem transplantation is defined as two autologous stem cell transplants that occur within 9 months of one another, and the patient did not have disease progression in the period between the two transplants.
• Presence of peripheral neuropathy ≥ grade 3 based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 4.0
• History of plasma cell leukemia or MM central nervous system (CNS) involvement.
• Receiving renal replacement therapy, hemodialysis, or peritoneal dialysis.
• Diagnosed with another concurrent malignancy requiring treatment.
• Known HIV or active hepatitis A, B, or C. Antidoby testing not required for screening
• Known hypersensitivity to pomalidomide, dexamethasone, or any excipients in elotuzumab, formulation, or recombinant protein
• Receiving any other investigational agents within 14 days prior to enrollment.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
• Pregnant and/or breastfeeding. Females of childbearing potential must have two negative pregnancy tests. The first test should be performed within 10-14 days of study entry, and the second test within 24 hours prior to prescribing pomalidomide.

Sponsors & Collaborators

• Bristol-Myers Squibb: collaborator
• Celgene: collaborator
• Washington University School of Medicine: lead

Study Sites (3)

Colorado Blood Cancer Institute (Sarah Cannon)

Denver, Colorado, 80218, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

University Health Network - Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Interventions

elotuzumab; pomalidomide; Dexamethasone; Calcium Dobesilate

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Results Point of Contact

• Title: Ravi Vij, M.D.
• Organization: Washington University School of Medicine

rvij@wustl.edu

314-454-8323

Study Officials

• Ravi Vij, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2017
• First Posted: January 24, 2017
• Study Start: November 22, 2017
• Primary Completion: September 29, 2022
• Study Completion (Estimated): September 26, 2027
• Last Updated: January 12, 2026
• Results First Posted: December 15, 2023

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); CA (1)