CompletedPhase 2

Carfilzomib, Lenalidomide, and Dexamethasone for Smoldering Multiple Myeloma

United States55 participantsStarted 2012-05-29

Plain-language summary

Background: * Multiple myeloma is a blood cancer that affects the plasma cells. These cells help produce antibodies and fight infection. Smoldering multiple myeloma (SMM) is a related condition that may develop into multiple myeloma. The current standard of care for SMM is close follow-up without treatment until multiple myeloma develops. However, researchers are studying possible treatments for SMM itself. One possible treatment involves a combination of cancer treatment drugs. * Lenalidomide is a drug that may help reduce or prevent the growth of cancer cells. Dexamethasone is a steroid that is often given with other anti-cancer drugs. These two drugs are an approved treatment for multiple myeloma that has not responded to at least one other treatment. Carfilzomib is an experimental drug that has been effective in treating multiple myeloma. Researchers want to combine these three drugs to see if they are a safe and effective treatment for SMM. Objectives: \- To see if carfilzomib, lenalidomide, and dexamethasone are a safe and effective treatment for smoldering multiple myeloma. Eligibility: \- Individuals at least 18 years of age who have SMM that is likely to progress to multiple myeloma. Design: * Participants will be screened with a physical exam and medical history. They will also have blood and urine tests, and baseline bone marrow scans. Bone marrow samples will also be collected. * Participants will have eight 28-day cycles of treatment with the three study drugs. The drugs will be given as tablets or as infusions. Treatment will be monitored with frequent blood tests and study visits. * After the first four cycles, participants who are eligible for a stem cell transplant will have their stem cells collected and stored for future use. * At the end of eight cycles, participants whose disease has not progressed will have up to 12 more cycles of treatment with lenalidomide tablets alone.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* INCLUSION CRITERIA: Patients must have histologically or cytologically confirmed Smoldering Multiple Myeloma confirmed by the Laboratory of Pathology, national Cancer Institute (NCI) or the Department of Laboratory Medicine, Clinical Center (CC) based on the International Myeloma Working Group Criteria: * Serum M-protein greater than or equal to 3 g/dl and/or bone marrow plasma cells greater than or equal 10% and \<60% * Absence of anemia: Hemoglobin \>10 g/dl * Absence of renal failure: serum creatinine \< 2.0 mg/dL * Absence of hypercalcemia: Calcium (Ca) \<10.5 mg/dl * Absence of lytic bone lesion on X-ray, computed tomography (CT), or positron-emission tomography (PET)/CT and not more than 1 lesion on spinal magnetic resonance imaging (MRI). (NOTE: At the discretion of the investigator, PET/CT may replace MRI in patients who have a contraindication to MRI.) * Involved-un-involved light chain ratio must be \<100 Measurable disease within the past 4 weeks defined by any one of the following: * Serum monoclonal protein greater than or equal to 1.0 g/dl * Urine monoclonal protein \>200 mg/24 hour * Serum immunoglobulin free light chain \>10 mg/dL AND abnormal kappa/lambda ratio NOTE: As of Amendment L (version date 05/17/2018), the primary endpoint is minimal residual disease (MRD(-) Complete Response (CR) rate; therefore, per the discretion of the Principal Investigator, patients without measurable disease (e.g., M-spike \<1) may also be enrolled. This is in line with…

What they're measuring

Percentage of Participants With Minimal Residual Disease (MRD)Negative Complete Response (CR) Per International Myeloma Working Group (IMWG) Criteria

Timeframe: 8 months

Trial details

NCT IDNCT01572480

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2022-03-03

Results submitted2022-07-06