CI

At a glance

ClinicalIndex Comparison Record
Phase 1Recruiting· 134 target
Drug / intervention
Ruxolitinib Oral Tablet [Jakafi] +2 moredrug
Likely dose
Not stated in record
Key inclusion· 10
  • ✓Confirmed diagnosis of MM by standard criteria (2 major criteria, or major+minor combinations)
  • ✓Currently has progressive MM with measurable disease (M-spike ≥0.5 g/dL, urine M-protein ≥200 mg/24h, involved SFLC >100 mg/L, or IgD ≥1500 mg/L)
  • ✓Relapsed or refractory MM from at least 2 prior lines including IMID and proteasome inhibitor
  • ✓Prior lenalidomide exposure regardless of response
Key exclusion· 13
  • ✕POEMS syndrome
  • ✕Plasma cell leukemia (>2.0 × 10^9/L circulating plasma cells)
  • ✕Primary amyloidosis
  • ✕Non-hematologic malignancy within past 5 years (except basal/squamous cell skin cancer, thyroid cancer, cervical/breast carcinoma in situ, low-grade prostate cancer, or surgically cured cancers)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03110822
NCT03110822Phase 1RecruitingUpdate OverdueUpdated 32mo ago · Completion was 21mo ago
Enrollment Stalled
Long Recruiting
Update Overdue
CompareCT.gov

A Phase 1 Study of Ruxolitinib, Steroids and Lenalidomide for Relapsed/Refractory Multiple Myeloma (RRMM) Patients

Oncotherapeutics·interventional·Posted Apr 12, 2017·Updated Nov 1, 2023

In Brief

A Phase 1 clinical trial evaluating Ruxolitinib Oral Tablet [Jakafi], Lenalidomide, and 1 other intervention for Multiple Myeloma. Currently recruiting, targeting 134 participants across 13 sites.

Signals

Enrollment appears stalled

Detailed Summary

This is a phase 1, multicenter, open-label study evaluating the safety and efficacy of ruxolitinib, steroids and lenalidomide among MM patients who currently show progressive disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Myeloma
CountriesUnited States
CollaboratorsIncyte Corporation

Timeline

Phase 1Recruiting
20172018201920202021202220232024202520262027
First PostedApr 12, 2017
Enrollment StartFeb 1, 2017
Primary CompletionSep 1, 2024
Study CompletionFeb 1, 2027
TodayJul 2, 2026
Enrollment to primary: 7.6 yearsPosted 9.2 years ago

Interventions

Ruxolitinib Oral Tablet [Jakafi]drug

Ruxolitinib will be administered on days 1-28 of the treatment cycle.

Lenalidomidedrug

Lenalidomide will be administered on Days 1-21 of the treatment cycle.

Methylprednisolonedrug

Methyl-prednisolone will be administered on Days 1-28 of the treatment cycle.