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

NCT03713294 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: MC1884NCI-2018-0214018-003574
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Refractory Plasma Cell Myeloma

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  Overall response rate (ORR) defined as a partial response (PR), very good partial response (VGPR), complete response (CR) or stringent CR (sCR). CR and sCR are defined in Outcome 2. VGPR requires: serum and urine M-protein detectable by immunofixation but not on electrophoresis OR \>= 90% reduction in serum M-protein and urine M-protein \<100 mg/24 h. If the only measurable disease is FLC, a \>90% reduction in the difference between involved and uninvolved FLC levels. PR requires: if present at baseline, \>= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>= 90% or to \<200 mg/24hrs. If the only measurable disease is FLC, a ≥50% reduction in the difference between involved and uninvolved FLC levels. If the only measurable disease is BM, a ≥ 50% reduction in BM PCs (provided the baseline PCs was ≥ 30%). If present at baseline, ≥ 50% reduction in the size (SPD) of soft tissue plasmacytomas.

  3 years

Secondary Outcomes (4)

• Percentage of Patients Achieving CR

  3 years

• Progression-free Survival (PFS)

  3 years

• Count of Patients That Experienced a Grade 3 or Greater Adverse Events

  37 months

• Overall Survival (OS)

  62 months

Study Arms (1)

Treatment (dexamethasone, elotuzumab, pomalidomide)

EXPERIMENTAL

Patients receive dexamethasone IV on days 1, 8, 15, and 22 of cycles 1-2 and IV on day 1 and PO on days 8, 15, and 22 of subsequent cycles and elotuzumab IV on days 1, 8, 15, and 22 of cycles 1-2 and day 1 of subsequent cycles. Patients also receive pomalidomide PO on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: Dexamethasone; Biological: Elotuzumab; Drug: Pomalidomide

Interventions

Dexamethasone DRUG

Given IV and PO

Also known as: Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex, Alin, Alin Depot, Alin Oftalmico, Amplidermis, Anemul mono, Auricularum, Auxiloson, Baycadron, Baycuten, Baycuten N, Cortidexason, Cortisumman, Decacort, Decadrol, Decadron, Decadron DP, Decalix, Decameth, Decasone R.p., Dectancyl, Dekacort, Deltafluorene, Deronil, Desamethasone, Desameton, Dexa-Mamallet, Dexa-Rhinosan, Dexa-Scheroson, Dexa-sine, Dexacortal, Dexacortin, Dexafarma, Dexafluorene, Dexalocal, Dexamecortin, Dexameth, Dexamethasone Intensol, Dexamethasonum, Dexamonozon, Dexapos, Dexinoral, Dexone, Dinormon, Dxevo, Fluorodelta, Fortecortin, Gammacorten, Hemady, Hexadecadrol, Hexadrol, Lokalison-F, Loverine, Methylfluorprednisolone, Millicorten, Mymethasone, Orgadrone, Spersadex, TaperDex, Visumetazone, ZoDex

Treatment (dexamethasone, elotuzumab, pomalidomide)

Elotuzumab BIOLOGICAL

Given IV

Also known as: BMS-901608, Empliciti, HuLuc-63, HuLuc63, PDL-063, PDL063

Treatment (dexamethasone, elotuzumab, pomalidomide)

Pomalidomide DRUG

Given PO

Also known as: 4-Aminothalidomide, Actimid, CC-4047, Imnovid, Pomalyst

Treatment (dexamethasone, elotuzumab, pomalidomide)

Eligibility Criteria

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

You may qualify if:

• 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 =\< 60 days of completing treatment with a daratumumab-containing regimen as part of any prior line of therapy.
• Measurable disease =\< 14 days prior to registration.
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2.
• Absolute neutrophil count (ANC) \>= 1,000 cell/mm\^3 without growth factor support (obtained =\< 14 days prior to registration).
• Platelet \>= 50,000 cells/mm\^3 for patients who have bone marrow plasmacytosis \< 50% or \>= 30,000 cells/mm\^3 for patients who have bone marrow plasmacytosis of \>= 50% (obtained =\< 14 days prior to registration).
• Total bilirubin =\< 1.5 x upper limit of normal (ULN) unless due to Gilbert's syndrome, in which case the direct bilirubin must be =\< 1.5 x ULN (obtained =\< 14 days prior to registration).
• Alanine aminotransferase (ALT) and aspartate transaminase (AST) =\< 3 x ULN (obtained =\< 14 days prior to registration).
• Prothrombin time (PT)/international normalized ratio (INR)/activated partial thromboplastin time (aPTT) =\< 1.5 x ULN OR if patient is receiving anticoagulant therapy and PT/INR or aPTT is within target range of therapy (obtained =\< 14 days prior to registration).
• Calculated or measured creatinine clearance \>= 30 ml/min (obtained =\< 14 days prior to registration).
• Negative urine or serum pregnancy test done =\< 14 days prior to registration, for persons of childbearing potential only.
• NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
• Provide written informed consent.

You may not qualify if:

• Non-secretory multiple myeloma (MM) or known immunoglobulin light chain (AL) amyloidosis.
• Clinically significant active infection requiring intravenous antibiotics (=\< 14 days prior to registration).
• \>= 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 =\< 3 years prior to registration.
• EXCEPTIONS:
• Adequately treated basal cell or squamous cell skin cancer.
• Any in situ cancer.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Dexamethasone; Calcium Dobesilate; auricularum; dexamethasone acetate; dexamethasone 21-phosphate; elotuzumab; pomalidomide

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

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: Sikander Ailawadhi
• Organization: Mayo Clinic

ailawadhi.sikander@mayo.edu

904/953-6468

Study Officials

• Sikander Ailawadhi, M.D.

  Mayo Clinic

  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: October 17, 2018
• First Posted: October 19, 2018
• Study Start: January 14, 2019
• Primary Completion: February 20, 2024
• Study Completion: November 14, 2024
• Last Updated: June 24, 2025
• Results First Posted: June 24, 2025

Record last verified: 2024-11

Locations

US (1)