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Pilot Study for Multiple Myeloma Treatment with Ruxolitinib, Lenalidomide, and Methylprednisolone

This study is looking at how well a combination of three drugs—ruxolitinib (Jakafi), lenalidomide, and methylprednisolone—works for people with multiple myeloma (a type of blood cancer) whose disease is getting worse. Researchers will give these medications in cycles and watch for changes in a marker called B cell maturation antigen (BCMA) in your blood to see how your disease is progressing. The main goal is to see how long it takes for the disease to get worse, measured over 54 months. You may be able to join if you are 18 or older and have a confirmed diagnosis of multiple myeloma based on specific criteria, such as plasmacytomas or a certain percentage of plasma cells in your bone marrow. The study is currently unclear on its recruitment status and plans to enroll 30 participants.

Study design
This is an open-label study, meaning both you and the study team will know which treatments you are receiving. It is a pilot study, which often means it's an early-stage investigation, and it aims to enroll 30 participants.
What's involved
Ruxolitinib will be taken daily for 28 days of each treatment cycle. Lenalidomide will be taken daily for 21 days of each cycle, and methylprednisolone will be taken daily for 28 days of each cycle.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, Time to Disease Progression, will be measured at 54 months, indicating a long-term follow-up period.

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NCT06209606

Pilot Study Using Changes in Serum BCMA to Determine Disease Progression in Multiple Myeloma

Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatment
Oncotherapeutics
~30 participants
Updated 2024-12-17 on ClinicalTrials.gov
What's tested:Ruxolitinib Oral Tablet [Jakafi]LenalidomideMethylprednisolone

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to Disease Progression (TTP)
Measured over 54 months

Conditions

Multiple Myeloma

Explore related trials

Multiple Myeloma

Where it's being run

1 sites across 1 states
California1

Study leadership

  • James Berenson, MD · PRINCIPAL_INVESTIGATOR · Oncotherapeutics

Who to contact

Richard Bailey
[email protected]
310-464-2190
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

any 2 of the major criteria
major criterion 1 plus minor criterion 2, 3, or 4
major criterion 3 plus minor criterion 1 or 3
minor criteria 1, 2, and 3, or 1, 2, and 4
a monoclonal immunoglobulin spike on serum electrophoresis of at least 0.5 g/dL and/or urine monoclonal protein levels of at least 200 mg/24 hours
for patients without measurable serum and urine M-protein levels, an involved SFLC \> 100 mg/L or abnormal SFLC ratio
for patients with IgD MM, a monoclonal immunoglobulin IgD of at least 5500 mg/L or meet other measurable disease eligibility criteria
Patients are considered relapsed when they progress greater than 8 weeks from their last dose of treatment
Patients are refractory when they progress while currently receiving the treatment or within 8 weeks of its last dose
Absolute neutrophil count ≥ 1.5 x 109/L
Platelet count ≥ 75 x 109/L
If the bone marrow is extensively infiltrated (≥ 70% plasma cells) then ≥ 50 x 109/L
If patient have creatinine clearance of less than 60mL/min, patient's platelet count must be greater than 150 x 109/L
Hemoglobin ≥ 8.0 g/dL within 21 days prior to enrollment
Calculated or measured CrCl \> 60 mL/minute per Cockcroft-Gault (Appendix 3)
Total bilirubin levels ≤ 2.0 mg/dL
AST (SGOT) and ALT (SGPT) ≤ 2 x ULN
Serum potassium 3.0 - 5.5 mEq/L

Exclusion

Myocardial infarction within 6 months prior to enrollment
New York Heart Association (NYHA) Class II or greater heart failure or uncontrolled angina
Clinically significant pericardial disease
Severe uncontrolled ventricular arrhythmias
Echocardiogram or MUGA evidence of LVEF below institutional normal within 28 days prior to enrollment
Electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening must be documented by the investigator as not medically relevant.
Severe hypercalcemia, i.e., serum calcium ≥ 12 mg/dL (3.0 mmol/L) corrected for albumin 7. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form 8. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study 9. Undergone major surgery within 28 days prior enrollment or has not recovered from side effects of such therapy (vertebroplasty or kyphoplasty is not considered to be a major surgery; however, the investigator is to discuss enrollment of a subject with a recent history of kyphoplasty with the medical monitor). 10. Pregnant or breastfeeding females (lactating females must agree not to breast feed while taking lenalidomide) 11. Received the following prior therapy:
Chemotherapy within 3 weeks of study drugs
Corticosteroids (\>20 mg/daily prednisone or equivalent) within 3 weeks of study drugs to ensure that steroid dose intensity at the beginning of the treatment is not altered by administration of steroids prior to the study. Consumption of steroids within 3 weeks of the treatment may interfere with efficacy and side effects due to differences of steroid intensity.
Immunotherapy, antibody therapy, immunomodulatory drugs, or proteasome inhibitors within 3 weeks of study drugs
Extensive radiation therapy within 28 days before study drugs. Receipt of localized radiation therapy does not preclude enrollment.
Use of any other experimental drug or therapy within 28 days of study drugs
JAK inhibitor including ruxolitinib 12. Strong CYP3A4 inhibitors, strong CYP3A4 inducers and fluconazole doses \>200 mg daily within 5 half-lives before study drugs. (For example, clarithromycin has half-life of 4 hours so washout period for clarithromycin is 20 hours.) 13. Known hypersensitivity to compounds of similar chemical or biological composition to thalidomide and lenalidomide or steroids. 14. Concurrent use of other anti-cancer agents or treatments 15. The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs 16. Known positivity for human immunodeficiency virus (HIV), hepatitis B or C, and /or active tuberculosis (TB) including subjects with latent TB or with the risk factor for activation of latent TB.

What this trial measures

  • Time to Disease Progression (TTP)54 months

    * To establish the utility of using an increase in sBCMA levels \> 25% or IMWG criteria for disease progression to direct this therapeutic approach, TTP will be measured, where TTP is defined as a number of days between the start of treatment (cycle 1 day 1) and PD. PD is defined by either change in sBCMA (≥25% increase from its nadir levels) or by standard IMWG criteria (using sM-protein and SFLC assessments), whichever occurs first. PD will be confirmed by two consecutive tests. * Duration of response 1 (DOR1), defined as the time from the first response to progressive disease as determined by either changes in sBCMA or IMWG criteria (whichever occurs first) while patients are on ruxolitinib and methylprednisolone treatment * Duration of response 2 (DOR2), defined as the time from the first response to progressive disease as determined by standard IMWG criteria while patients on ruxolitinib, lenalidomide and methylprednisolone treatment