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Combination Study for High Risk Multiple Myeloma Patients

NCT03104270 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2022-03-31

No results posted yet for this study

Summary

Despite the recent introduction of novel anti-multiple myeloma (MM) agents, high risk MM remains with poor prognosis and a therapeutic challenge. Elotuzumab (ELO) is a humanized monoclonal antibody that recognizes CS1/CD139, a molecule highly expressed in MM cells. The ELO (10 mg/kg), lenalidomide (LEN) and dexamethasone (DEX) combination achieves high overall response rates (ORR) and long progression-free survival (PFS) for patients with relapsed/refractory disease (RR) MM and those with impaired renal function. However, its efficacy for MM patients with high risk characteristics is still unknown. Pomalidomide (POM) is a recently approved immunomodulatory agent (IMiD) that produces response rates for high-risk RRMM patients when used in combination with DEX and other agents, including the proteasome inhibitor (PI) bortezomib (BTZ). POM has also demonstrated activity for LEN refractory patients. Carfilzomib (CFZ) is a potent second generation PI that has shown to be efficacious for IMiD and BTZ refractory patients as well as high risk patients carrying cytogenetic abnormalities. In this study, we propose to evaluate efficacy and safety of ELO in combination with POM, DEX and CFZ for high-risk RRMM patients.

Conditions

Interventions

DRUG

Elotuzumab

Elotuzumab IV at 10mg/kg Elotuzumab IV at 20mg/kg

DRUG

Pomalidomide

Pomalidomide PO at 3mg

DRUG

Carfilzomib

Carfilzomib 20mg/m2 IV Carfilzomib 56mg/m2 IV

DRUG

Dexamethasone

Dexamethasone 28mg PO Dexamethasone 40mg PO or IV Dexamethasone 8mg IV

Sponsors & Collaborators

  • Oncotherapeutics

    lead INDUSTRY

Principal Investigators

  • James R Berenson, MD · Oncotherapeutics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-13
Primary Completion
2019-10-25
Completion
2020-01-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03104270 on ClinicalTrials.gov