Study of Ibrutinib in Combination With Revlimid/Dexamethasone in Relapsed/Refractory Multiple Myeloma

Part of paid clinical trials in Maywood, Illinois.

Sponsor
Alliance Foundation Trials, LLC.
Study ID
NCT03702725
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ibrutinib — DRUG
    Ibrutinib administered on every day of each 28 day cycle. Dosage depends on timing of patient enrollment and dosage tolerance by patients already enrolled.
  • Lenalidomide — DRUG
    Lenalidomide administered on days 1-21 of each 28 day cycle. Dosage depends on findings from Dose Escalation phase.
  • Dexamethasone — DRUG
    Dexamethasone administered on days 1, 8, 15, and 22 of every 28 day cycle. Dosage depends on findings from Dose Escalation phase.

Study Details

This is a registration, open-label phase 1 study of the combination of ibrutinib/lenalidomide:/dexamethasone in women and men with relapsed/refractory multiple myeloma.

Key Dates

Start date
Aug 29, 2019
Status verified
Apr 2025
Primary completion
Sep 27, 2024
Completion
Oct 4, 2024

Study Design

Enrollment
14 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation
    Dose escalation will consist of three different drug levels of Ibrutinib, Lenalidomide, and Dexamethasone. Dose Escalation (Ibrutinib, Lenalidomide, Dexamethasone Combination)
  • Experimental: Dose Expansion
    Dosage of the combination will depend on the determine of maximum tolerated dose learned from the Dose Escalation phase. Dose Expansion (Ibrutinib, Lenalidomide, Dexamethasone Combination)

Primary Outcome Measure

Number of Participants With Dose Limiting Toxicities [ Time Frame: During cycle 1 (28-day cycle) ]

Locations (5)

FacilityCityStateZIPSite coordinators
Loyola University Medical CenterMaywoodIllinois60153-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Wake Forest Baptist Comprehensive Cancer CenterWinston-SalemNorth Carolina27157-
The Ohio State University Wexner Medical Center/James Cancer HospitalColumbusOhio43210-
Rhode Island HospitalProvidenceRhode Island02903-

Find similar trials in Maywood, IL

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Loyola University Medical Center· Maywood, ILDana Farber Cancer Institute· Boston, MAWake Forest Baptist Comprehensive Cancer Center· Winston-Salem, NCThe Ohio State University Wexner Medical Center/James Cancer Hospital· Columbus, OHRhode Island Hospital· Providence, RI

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