Blood Cancers
Acute Myeloid Leukemia (AML) or High-Grade Myelodysplastic Syndrome (MDS): UW RG1006293
An informational and data collection trial for both newly diagnosed AML or MDS patients who cannot undergo intensive induction therapy who are receiving treatment with oral Venetoclax along with chemotherapy
Patient Population
Has a diagnosis of Multiple Myeloma (MM) based on standard criteria per protocol
Currently has MM with measurable disease, defined as:
o a monoclonal immunoglobulin spike on serum electrophoresis of at least 0.5 g/dL and/or
o urine monoclonal protein levels of at least 200mg/24 hours
o for patients without measurable serum and urine M-protein levels, an involved SFLC > 100 mg/L or abnormal SFLC ratio
Currently has progressive MM
MM patients that are relapsed or have refractory disease from at least 2 regimens or lines of therapy including an IMID and a proteasome inhibitor, are eligible for enrollment provided they fulfill the other eligibility criteria:
o Patients are considered relapsed, when they progress greater than 8 weeks from their last dose of treatment.
o Patients are refractory when they progress while currently receiving the treatment or within 8 weeks of its last dose.
Previous exposure to lenalidomide independent of the response
The patient is not a candidate for a transplant
Able to take aspirin (acetylsalicylic acid, ASA) at 81 or 325 mg/daily as antiplatelet therapy if platelet count is above 30 x 10E9/L (subjects intolerant to ASA may use warfarin or low molecular weight heparin)
(Only key eligibility criteria listed above)
Number of Patients: 106 (Globally)
Study Objectives
To establish the MTD, determined via the number of dose-limiting toxicities (DLTs) per dose level, of ruxolitinib in combination with steroids and lenalidomide for MM patients currently with progressive disease.
Treatment Information
After consenting, all participants will undergo baseline screening tests to confirm eligibility.
Once eligibility is confirmed patients will be assigned to take one of the combinations of Ruxolitinib, lenalidomide and steroids.
o Part 1: Up to 49 participants will be enrolled in study group 1. If you are assigned to study group 1, you will take ruxolitinib, lenalidomide and methylprednisolone.
o Part 2: Up to 29 participants will be enrolled in study group 2. If you are assigned to study group 2, you will first take ruxolitinib and methylprednisolone. You will continue this treatment until your disease gets worse. At this point lenalidomide will be added to your treatment and you will continue ruxolitinib, methylprednisolone and lenalidomide treatment.
o Part 3: Up to 28 participants will be enrolled in study group 3. If you are assigned to study group 3, you will take ruxolitinib, lenalidomide and methylprednisolone.
o Part 4: Up to 28 participants will be enrolled in study group 4. If you are assigned to study group 4, you will take ruxolitinib and methylprednisolone.
Treatment will continue until disease progression or intolerable toxicity.
On-Site Study Visits
Consent/Enrollment Visit(s)
Protocol specified visits
End of Treatment Visit
A follow-up visits will be conducted every 3 months until your disease progresses, after that study-related follow up visits will continue every 6 months, in addition to your regular treatment
