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Phase 2 N=37 Treatment

Dexamethasone, Elotuzumab, and Pomalidomide in Treating Patients With Refractory Multiple Myeloma

Refractory Plasma Cell Myeloma

Enrolled (actual)
37
Serious AEs
32.4%
Results posted
Jun 2025
Primary outcome: Primary: Overall Response Rate — 0.35 proportion of participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Dexamethasone (Drug); Elotuzumab (Biological); Pomalidomide (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Mayo Clinic
Primary completion
Feb 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Overall Response Rate
0.35
SECONDARY
Percentage of Patients Achieving CR
SECONDARY
Progression-free Survival (PFS)
3.7
SECONDARY
Count of Patients That Experienced a Grade 3 or Greater Adverse Events
27
SECONDARY
Overall Survival (OS)
56.7

Summary

This phase II trial studies how well dexamethasone, elotuzumab, pomalidomide work in treating patients with multiple myeloma that has not responded to previous treatment. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as elotuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Pomalidomide may stop the growth of multiple myeloma by blocking the growth of new blood vessels necessary for tumor growth. Giving dexamethasone, elotuzumab, pomalidomide may work better in treating patients with multiple myeloma.

Eligibility Criteria

Inclusion Criteria

  • Age >= 18 years
  • Pathologically confirmed diagnosis of multiple myeloma and noted to have progressive disease (International Myeloma Working Group [IMWG] criteria).
  • At least one prior line of therapy.
  • Disease refractory to daratumumab as defined by disease progression while on or = = 1,000 cell/mm^3 without growth factor support (obtained = = 50,000 cells/mm^3 for patients who have bone marrow plasmacytosis = 30,000 cells/mm^3 for patients who have bone marrow plasmacytosis of >= 50% (obtained = = 30 ml/min (obtained = = Grade 3 neuropathy and/or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
  • Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy.
  • NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial.
  • Concurrent therapy considered investigational.
  • NOTE: Patients must not be planning to receive any radiation therapy (except localized radiation for palliative care that must be completed prior to starting Cycle 1, Day 1).
  • Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
  • Pregnant women.
  • Nursing women (lactating females are eligible provided that they agree not to breast feed while taking lenalidomide).
  • Men or women of childbearing potential who are unwilling to employ adequate contraception.
  • Other active malignancy = = Grade 3 cardiac arrhythmias noted =< 14 days prior to registration.
  • Currently active, clinically significant hepatic impairment Child-Pugh class B or C according to the Child Pugh classification.
  • Exhibiting clinical signs of meningeal involvement of multiple myeloma.
  • Known severe chronic obstructive pulmonary disease or asthma defined as forced expiratory volume (FEV1) in 1 second < 60% of expected.
  • Prior exposure to elotuzumab.
  • Prior history of disease refractory to pomalidomide.
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
  • Uncontrolled intercurrent illness including, but not limited to:
  • Ongoing or active infection.
  • Symptomatic congestive heart failure.
  • Unstable angina pectoris.
  • Cardiac arrhythmia.
  • Or psychiatric illness/social situations that would limit compliance with study requirements.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03713294). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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