Elotuzumab, Lenalidomide and Dexamethasone in Treatment of Transplant-Eligible Newly Diagnosed Multiple Myeloma Patients

NCT02843074 | Completed Phase 2 Results FDA Drug

• 1 other identifier: SCRI MM61
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 6

Brief Summary

This is a phase 2, single arm, open-label, multicenter study to evaluate the feasibility and tolerance of the combination of elotuzumab, lenalidomide, and dexamethasone in the induction, consolidation, and maintenance treatment of transplant eligible, newly diagnosed multiple myeloma patients.

Conditions

Multiple Myeloma

Keywords

B-cell tumors; autologous stem cell transplantation; blood cancers

Outcome Measures

Primary Outcomes (1)

• Induction Feasibility Rate (IFR)

  Defined as the percentage of patients who successfully complete four 28-day cycles of induction therapy with elotuzumab, lenalidomide and dexamethasone (ERd) and start autologous stem cell transplantation (ASCT).

  approximately 22 weeks (16 weeks of treatment and 6 weeks allowance for planning and scheduling mobilization and ASCT).

Secondary Outcomes (7)

• Complete Response Rate (CRR) for Complete Time on Study

  every 4 weeks until end of treatment visit, and every 3 months thereafter up to 3 years

• Overall Response Rate (ORR) for Complete Time on Study

  every 4 weeks until end of treatment visit, and every 3 months thereafter up to 3 years

• Progression-free Survival (PFS)

  every 4 weeks until end of treatment visit, and every 3 months thereafter up to 3 years

• Overall Survival (OS)

  every 4 weeks until end of treatment visit, and up to 3 years thereafter

• Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety

  weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation, and monthly for 24 months of Maintenance, up to 30 days after last dose of study drugs.

Study Arms (1)

ERd Therapy

EXPERIMENTAL

INDUCTION: Cycles 1-2: elotuzumab 10mg/kg IV days 1, 8, 15, 22; lenalidomide (len) 25mg orally (PO), once daily (QD) on days 1-21; dexamethasone (dex) 28 mg PO (3-24 hrs before elotuzumab IV) and 8mg IV (45-90 minutes before elotuzumab) days 1, 8, 15, 22. Cycles 3-4: elotuzumab 10mg/kg IV days 1 and 15; len 25mg PO QD days 1-21; dex 8mg PO (3-24 hrs before elotuzumab IV) and 8mg IV (45-90 minutes before elotuzumab) days 1 and 15; dex 40mg PO days 8 and 22. CONSOLIDATION: Four 28-day cycles: elotuzumab 10mg/kg IV days 1 and 15; len 15mg PO QD days 1-21; dex 28mg PO (3-24 hrs before elotuzumab) and 8mg IV (45-90 minutes before elotuzumab) days 1 and 15; dex 40mg PO days 8 and 22. MAINTENANCE: After completing consolidation therapy patients without progressive disease will receive, for up to 24 months, 28-day cycles of elotuzumab 20mg/kg IV day 1; len 10mg +/- 5mg PO QD days 1-21; dex 28mg PO (3-24 hrs before elotuzumab) and 8mg IV (45-90 minutes prior to elotuzumab) day 1.

Drug: elotuzumab; Drug: Lenalidomide; Drug: Dexamethasone; Procedure: autologous stem cell transplantation

Interventions

elotuzumab DRUG

Given intravenously (IV)

Also known as: Empliciti

ERd Therapy

Lenalidomide DRUG

Given by IV

Also known as: Revlimid

ERd Therapy

Dexamethasone DRUG

Given orally (PO) or by IV

Also known as: Decadron

ERd Therapy

autologous stem cell transplantation PROCEDURE

Also known as: ASCT

ERd Therapy

Eligibility Criteria

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

You may qualify if:

• Newly diagnosed myeloma requiring systemic chemotherapy as per International Myeloma Working Group (IMWG) uniform criteria and Diagnostic Criteria and Staging for Multiple Myeloma
• Ideally, no prior therapy, or
• No more than 1 cycle of therapy for emergent control of disease prior to enrolling on study, including prior treatment of hypercalcemia, spinal cord compression, or active and/or aggressively progressing myeloma with corticosteroids or lenalidomide or bortezomib-based regimens (treatment dose should not exceed the equivalent of 160 mg of dexamethasone in a 4 week period, or not more than 1 cycle)
• Bisphosphonates are permitted
• Eligible and plan to undergo ASCT in first remission
• Measurable disease, prior to initial treatment as indicated by one or more of the following:
• Serum M-protein ≥1.0 g/dL
• Urine M-protein ≥200 mg/24 hours
• Serum free light chain assay: involved free light chain level ≥10 mg/dL (≥100 mg/L) provided the serum free light chain ratio is abnormal.
• Ability to take aspirin or other venous thromboembolism (VTE) anticoagulant therapy
• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 thru 2
• Adequate hematologic, renal, and liver function.
• All study participants must be registered into the mandatory Revlimid REMS® program and must be willing and able to comply with the requirements of that program.
• Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program.
• Male patients with female partners of childbearing potential and female patients of childbearing potential are required to use two forms of acceptable contraception, including one barrier method, during their participation in the study and for 28 days following last dose of study drugs. Male patients must also refrain from donating semen or sperm during their participation in the study.

You may not qualify if:

• Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes (POEMS) syndrome
• Plasma cell leukemia
• Waldenström's macroglobulinemia or IgM myeloma
• Presence of other active cancers, or history of treatment for invasive cancer ≤5 years. Patients with Stage I cancer who have received definitive local treatment and are considered unlikely to recur are eligible. All patients with previously treated in situ carcinoma (i.e., non-invasive) are eligible, as are patients with a history of non-melanoma skin cancer.
• Radiotherapy to multiple sites or immunotherapy within 4 weeks before start of protocol treatment (localized radiotherapy to a single site at least 1 week before start is permissible)
• Major surgical procedures ≤28 days of beginning study drug, or minor surgical procedures ≤7 days. No waiting required following port-a-cath placement.
• Acute active infection requiring systemic antibiotics, antivirals, or antifungals within 2 weeks prior to first dose of study treatment
• Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of oral therapy (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea Grade ≥2, and malabsorption syndrome)
• Any of the following cardiac diseases currently or within the last 6 months:
• Left ventricular ejection fraction (LVEF) \<40% as determined by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scan
• Unstable angina pectoris
• Congestive heart failure (New York Heart Association ≥ Grade 2
• Acute myocardial infarction
• Conduction abnormality not controlled with pacemaker or medication
• Significant ventricular or supraventricular arrhythmias (patients with chronic rate-controlled atrial fibrillation in the absence of other cardiac abnormalities are eligible)

Sponsors & Collaborators

• SCRI Development Innovations, LLC: lead
• Bristol-Myers Squibb: collaborator

Study Sites (6)

Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States

Location

Center for Cancer and Blood Disorders

Bethesda, Maryland, 20817, United States

Location

HCA Midwest Health/Research Medical Center

Kansas City, Missouri, 64132, United States

Location

Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States

Location

Tennessee Oncology

Chattanooga, Tennessee, 37404, United States

Location

Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Hematologic Neoplasms

Interventions

elotuzumab; Lenalidomide; 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; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; 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

Results Point of Contact

• Title: Sarah Cannon Development Innovations, LLC
• Organization: Sarah Cannon Development Innovations, LLC

CANN.InnovationsMedical@sarahcannon.com

844-710-6157

Study Officials

• Jesus Berdeja, MD

  SCRI Development Innovations, LLC

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: 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: July 20, 2016
• First Posted: July 25, 2016
• Study Start: September 21, 2016
• Primary Completion: July 27, 2021
• Study Completion: October 5, 2021
• Last Updated: December 5, 2023
• Results First Posted: October 17, 2022

Record last verified: 2022-09

Locations

US (6)