Multiple Myeloma study: Lenalidomide vs Methylprednisolone
Official title A Phase 1 Study of Ruxolitinib, Steroids and Lenalidomide for Relapsed/Refractory Multiple Myeloma (RRMM) Patients
ClinicalTrials.gov ID: NCT03110822
What this study is testing
What is Ruxolitinib Oral Tablet [Jakafi]?
Ruxolitinib Oral Tablet [Jakafi] is an investigational medicine, taken by mouth twice daily, being studied as a potential treatment for multiple myeloma.
Also referred to as Ruxolitinib, Jakavi.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study is looking at how safe the drug combo is and whether it shows any effect against the cancer in patients whose disease is getting worse.
- Who it's for
- Adults with multiple myeloma whose disease is progressing after previous treatments.
- What's involved
- Participants will take ruxolitinib, steroids and lenalidomide and will have regular clinic visits and tests to check safety and response.
- Time commitment
- The trial runs for several months and requires multiple study visits during that time.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Plasmacytomas on tissue biopsy.
- Bone marrow plasmacytosis (greater than 30% plasma cells).
- bone marrow plasmacytosis (10% to 30% plasma cells)
- monoclonal immunoglobulin present but of lesser magnitude than given under major criteria
- lytic bone lesions
You likely can't join if
- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- Plasma cell leukemia (\> 2.0 × 10E9/L circulating plasma cells by standard differential)
- Primary amyloidosis
- Non-hematologic malignancy within the past 5 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or...
- Myocardial infarction within 6 months prior to enrollment
- New York Heart Association (NYHA) Class II or greater heart failure or uncontrolled angina
See the full eligibility criteria
- Plasmacytomas on tissue biopsy.
- Bone marrow plasmacytosis (greater than 30% plasma cells).
- bone marrow plasmacytosis (10% to 30% plasma cells)
- monoclonal immunoglobulin present but of lesser magnitude than given under major criteria
- lytic bone lesions
- 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
- a monoclonal immunoglobulin spike on serum electrophoresis of at least 0.5 g/dL and/or
- urine monoclonal protein levels of at least 200mg/24 hours
- for patients without measurable serum and urine M-protein levels, an involved SFLC \> 100 mg/L or abnormal SFLC ratio
- Patients are considered relapsed, when they progress greater than 8 weeks from their last dose of treatment.
- Absolute neutrophil count ≥ 1.5 x 10E9/L; if the bone marrow is extensively infiltrated ( ≥ 70% plasma cells) then ≥ 1.0 x 10E9/L
- Platelet count ≥ 75 x 10E9/L; if the bone marrow is extensively infiltrated ( ≥ 70% plasma cells) then ≥ 50 x 10E9/L patients must not have received platelet transfusion for at least 7 days prior to receiving screening...
- Hemoglobin ≥ 8.0 g/dL within 21 days prior to enrollment. Use of erythropoietic stimulating factors and red blood cell (RBC) transfusions per institutional guidelines is allowed
- 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 (Appendix 3).
- Total bilirubin levels ≤ 2.0 mg/dL (normal levels)
- AST (SGOT) and ALT (SGPT) ≤ 2 x ULN
- Serum potassium 3.0 - 5.5 mEq/L 11\. Patients must be registered into the mandatory REVLIMID REMS™ program, and be willing and able to comply with the requirements of the REVLIMID REMS™ program 12\.
- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- Plasma cell leukemia (\> 2.0 × 10E9/L circulating plasma cells by standard differential)
- Primary amyloidosis
- Non-hematologic malignancy within the past 5 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the cervix or breast
- 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 has to 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
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
- 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
- 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
- Pregnant or breast feeding females (lactating females must agree not to breast feed while taking lenalidomide)
- 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...
- Immunotherapy or antibody therapy as well as thalidomide, arsenic trioxide, or bortezomib within 21 days before study drugs
- Lenalidomide within 7 days before study drugs
- Lenalidomide within 21 days before study drugs (Part 4 only)
- 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
- Strong CYP3A4 inhibitors, strong CYP3A4 inducers and fluconazole doses \>200 mg daily within 5 half-lives before study drugs.
- Known hypersensitivity to compounds of similar chemical or biological composition to thalidomide and lenalidomide or steroids.
- Concurrent use of other anti-cancer agents or treatments
- The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
- Known positivity for human immunodeficiency virus (HIV), hepatitis B or C, and /or active tuberculosis (TB) including people with latent TB or with the risk factor for activation of latent TB.
The study team makes the final eligibility decision.
Where it is enrolling
- Alhambra, California, United States
- Encinitas, California, United States
- West Hills, California, United States
- West Hollywood, California, United States
- Jacksonville, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Alhambra, California, United States; Encinitas, California, United States; West Hills, California, United States; West Hollywood, California, United States; Jacksonville, Florida, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.