OncoMatch/Clinical Trials/NCT03110822
A Phase 1 Study of Ruxolitinib, Steroids and Lenalidomide for Relapsed/Refractory Multiple Myeloma (RRMM) Patients
Is NCT03110822 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Ruxolitinib Oral Tablet [Jakafi] and Lenalidomide for multiple myeloma.
Treatment: Ruxolitinib Oral Tablet [Jakafi] · Lenalidomide · Methylprednisolone — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: immunomodulatory drug
relapsed or have refractory disease from at least 2 regimens or lines of therapy including an IMID and a proteasome inhibitor
Must have received: proteasome inhibitor
relapsed or have refractory disease from at least 2 regimens or lines of therapy including an IMID and a proteasome inhibitor
Must have received: lenalidomide (lenalidomide)
Previous exposure to lenalidomide independent of the response
Cannot have received: chemotherapy
Chemotherapy within 3 weeks of study drugs
Cannot have received: corticosteroid
Exception: ≤20 mg/daily prednisone or equivalent allowed
Corticosteroids (>20 mg/daily prednisone or equivalent) within 3 weeks of study drugs
Cannot have received: immunotherapy
Immunotherapy or antibody therapy as well as thalidomide, arsenic trioxide, or bortezomib within 21 days before study drugs
Cannot have received: antibody therapy
Immunotherapy or antibody therapy as well as thalidomide, arsenic trioxide, or bortezomib within 21 days before study drugs
Cannot have received: immunomodulatory drug (thalidomide)
Immunotherapy or antibody therapy as well as thalidomide, arsenic trioxide, or bortezomib within 21 days before study drugs
Cannot have received: (arsenic trioxide)
Immunotherapy or antibody therapy as well as thalidomide, arsenic trioxide, or bortezomib within 21 days before study drugs
Cannot have received: proteasome inhibitor (bortezomib)
Immunotherapy or antibody therapy as well as thalidomide, arsenic trioxide, or bortezomib within 21 days before study drugs
Cannot have received: lenalidomide (lenalidomide)
Lenalidomide within 7 days before study drugs
Cannot have received: lenalidomide (lenalidomide)
Exception: Part 4 only
Lenalidomide within 21 days before study drugs (Part 4 only)
Cannot have received: radiation therapy
Exception: localized radiation therapy allowed
Extensive radiation therapy within 28 days before study drugs. Receipt of localized radiation therapy does not preclude enrollment.
Cannot have received: experimental therapy
Use of any other experimental drug or therapy within 28 days of study drugs
Cannot have received: (strong CYP3A4 inhibitors, strong CYP3A4 inducers, fluconazole >200 mg daily)
Strong CYP3A4 inhibitors, strong CYP3A4 inducers and fluconazole doses >200 mg daily within 5 half-lives before study drugs
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1.5 x 10E9/L (or ≥ 1.0 x 10E9/L if bone marrow is extensively infiltrated); Platelet count ≥ 75 x 10E9/L (or ≥ 50 x 10E9/L if bone marrow is extensively infiltrated; must not have received platelet transfusion for at least 7 days prior to screening); Hemoglobin ≥ 8.0 g/dL within 21 days prior to enrollment
Kidney function
Calculated or measured creatinine clearance (CrCl) of > 60 mL/minute (Study Part 1,2,3(2), and 4) or 30 to ≤ 60 mL/minute (Part 3(1)) as calculated by Cockcroft-Gault method
Liver function
Total bilirubin levels ≤ 2.0 mg/dL (normal levels); AST (SGOT) and ALT (SGPT) ≤ 2 x ULN
Cardiac function
No impaired cardiac function or clinically significant cardiac diseases, including: MI within 6 months, NYHA Class II or greater heart failure, uncontrolled angina, significant pericardial disease, severe uncontrolled ventricular arrhythmias, LVEF below institutional normal, ECG evidence of acute ischemia or active conduction system abnormalities
Laboratory test results within these ranges at Screening and confirmed at enrollment prior to drug dosing on Cycle 1, Day 1: Absolute neutrophil count ≥ 1.5 x 10E9/L... Platelet count ≥ 75 x 10E9/L... Hemoglobin ≥ 8.0 g/dL... Calculated or measured creatinine clearance (CrCl) of > 60 mL/minute... Total bilirubin levels ≤ 2.0 mg/dL... AST (SGOT) and ALT (SGPT) ≤ 2 x ULN... Serum potassium 3.0 - 5.5 mEq/L
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Global Oncology, Inc. · Alhambra, California
- Comprehensive Blood and Cancer Center · Bakersfield, California
- California Cancer Associates for Research & Excellence (cCARE) · Encinitas, California
- Compassionate Care Research Group, Inc. · Fountain Valley, California
- Robert A. Moss, M.D., F.A.C.P., Inc. · Fountain Valley, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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