Elotuzumab for Multiple Myeloma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Yale New Haven Hospital, New Haven, CT
Multiple Myeloma+1 More
Elotuzumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This study is evaluating whether two drugs approved for treating multiple myeloma are safe and more effective when used together.

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Eligible Conditions

  • Multiple Myeloma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Elotuzumab will improve 2 primary outcomes and 4 secondary outcomes in patients with Multiple Myeloma. Measurement will happen over the course of 28 days.

28 days
Maximum tolerated dose of elotuzumab in combination with belantamab mafodotin in subjects
Number of Participants who Experienced Dose-Limiting Toxicities (DLTs)
Day 30
To evaluate minimal residual disease (MRD) by multi-parameter flow cytometry and by next-generation sequencing (NGS)
Year 2
Preliminary evaluation of clinical efficacy/response rate
Year 2
To evaluate progression free survival (PFS)
Year 2
To evaluate overall survival (OS)

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Belantamab Mafodotin and Elotuzumab Arm
1 of 1
Experimental Treatment

This trial requires 24 total participants across 1 different treatment group

This trial involves a single treatment. Elotuzumab is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Belantamab Mafodotin and Elotuzumab ArmElotuzumab will be administered via intravenous infusion at an established dose of 10 mg/kg on days 1, 8, 15, 22 every 28 days for cycles 1 and 2, followed by 20mg/kg on day 1 of each cycle thereafter, cycles repeated every 28 days. Belantamab mafodotin will be administered via IV infusion. There will be 2 dose levels for belantamab mafodotin, with the starting dose of 1.9 mg/kg IV at every 4 week interval. Up to 12 subjects will be treated at this dose level. If the initial dose is found to be too toxic, dose of belantamab mafodotin 1.9 mg/kg every 8 weeks will be tested. .
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Elotuzumab
FDA approved
Belantamab mafodotin
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: followed for progression free survival until progression up to 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly followed for progression free survival until progression up to 2 years for reporting.

Who is running the study

Principal Investigator
N. N.
Prof. Natalia Neparidze, Assistant Professor, Medical Oncology, Hematology & Oncology
Yale University

Closest Location

Yale New Haven Hospital - New Haven, CT

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Multiple Myeloma or the other condition listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Hemoglobin ≥8.0 g/dL
Total bilirubin ≤1.5X ULN (Isolated bilirubin ≥1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
ALT ≤2.5 X ULN
Participant must have MM that has relapsed after or is refractory to at least 3 prior lines of therapy. Relapsed/refractory disease as defined by IMWG criteria.
Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
Participant must be ≥ 18 years of age
Prior line of therapy must include iMID and proteasome inhibitor. Prior treatment with anti-CD38 monoclonal antibody is allowed but not required.
ANC ≥1 X 109/L
Platelets ≥75 X 109/L
eGRF ≥40 mL/min/ 1.73 m2

Patient Q&A Section

What is the average age someone gets multiple myeloma?

"A mean age of 60 years was calculated for the whole group of patients and 56 years for the male group, thus patroting a male predominance of the disease with respect to its incidence (3:1). Interestingly, patients diagnosed at an earlier age had worse survival outcomes compared with those diagnosed later." - Anonymous Online Contributor

Unverified Answer

What is elotuzumab?

"Elotuzumab is a humanized monoclonal antibody targeting CD22, a cell surface antigen present on B cells and T cells. It is being developed for the treatment of relapsed or refractory chronic lymphocytic leukemias and chronic lymphocytic leukemia (CLL)/small lymphocyte lymphoma (SLL). In April 2014, elotuzumab entered phase III clinical trials for relapsed chronic lymphocytic leukaemia (CLL) and relapsed follicular lymphoma (FL) patients who had received at least two prior systemic therapies. Results from these studies were published in 2015. Elotuzumab was approved by the U.S." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating multiple myeloma?

"The developments in MM therapy have been remarkable over the past decade. However, many of them still need further investigation. Nevertheless, advances in our knowledge of MM biology have allowed us to pursue novel therapeutic approaches. In particular, MM is now treated with drugs such as lenalidomide and thalidomide that target the immunoglobulin light chain (IgLC). These drugs induce apoptosis in MM cells and increase survival of MM patients who relapse after autologous stem cell transplantation (ASCT). Lenalidomide has also shown efficacy in newly diagnosed MM patients (before ASCT), but this has not been reported with thalidomide." - Anonymous Online Contributor

Unverified Answer

Can multiple myeloma be cured?

"Patients with MM are able to respond to treatment and have an improved quality of life but do not experience complete remission. In our series, long-term survival was lower than expected. Survival was better in patients with a shorter disease duration and less advanced stage at diagnosis. Further studies should evaluate whether autologous stem cell transplantation provides a more favorable outcome for these patients." - Anonymous Online Contributor

Unverified Answer

How quickly does multiple myeloma spread?

"Multiple myeloma sometimes spreads to the skin but this seems to be uncommon. Also, multiple myeloma does not usually spread to the brain. The likelihood that multiple myeloma will spread to the lungs appears low. More studies are needed to investigate whether patients with multiple myeloma should receive an MRI scan of the spine every 6 months." - Anonymous Online Contributor

Unverified Answer

How many people get multiple myeloma a year in the United States?

"The incidence of MM in the US is low at about 1 per 100,000 person years. However, the number of new cases every year is relatively high, particularly among older persons. More than half of all cases occur in individuals 65 years of age or older." - Anonymous Online Contributor

Unverified Answer

Does multiple myeloma run in families?

"Findings from a recent study has shown that MM does not exhibit a familial pattern. We believe that these findings contradict previous reports demonstrating increased frequency of MM among first degree relatives of patients with MM." - Anonymous Online Contributor

Unverified Answer

How does elotuzumab work?

"Elotuzumab has been previously studied on early B-cell lymphomas, solid tumors, and other malignancies. Recent findings expands its role into MM. It shows superiority over bortezomib in treating MM and may represent a new therapeutic option. Recent findings reported here will help to define the clinical use of elotuzumab in MM." - Anonymous Online Contributor

Unverified Answer

What are common treatments for multiple myeloma?

"Most patients with MM receive some form of therapy, including alkylating agents, proteasome inhibitors, steroids, and bortezomib. Patients who present with extramedullary disease tend to have more aggressive therapy." - Anonymous Online Contributor

Unverified Answer

What is multiple myeloma?

"Multiple myeloma is a cancer of the bone marrow characterized by the proliferation of abnormal plasma cells. We examined the epidemiology of multiple myeloma in the United States using data from the National Cancer Institute SEER database and Medicare claims. The overall incidence of MM was 4.8 per 100,000 persons per year. Incidence increased with age; men were affected more often than women." - Anonymous Online Contributor

Unverified Answer

Has elotuzumab proven to be more effective than a placebo?

"Eltuzumab shows promise as an effective therapy for relapsed multiple myeloma. The efficacy of this antibody justifies the further investigation of its role in combination regimens and warrants comparison against other drugs in phase II and III studies." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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