Phase 2 N=55 Treatment

Carfilzomib, Lenalidomide, and Dexamethasone for Smoldering Multiple Myeloma

Multiple Myeloma

Bottom Line

View on ClinicalTrials.gov: NCT01572480 ↗

Enrolled (actual)

Serious AEs

22.2%

Results posted

Sep 2022

Primary outcome: Primary: Percentage of Participants With Minimal Residual Disease (MRD)Negative Complete Response (CR) Per International Myeloma Working Group (IMWG) Criteria — 70.4 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Carfilzomib (Drug); Revlimid (Drug); Dexamethasone (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: National Cancer Institute (NCI)
Primary completion: Mar 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Minimal Residual Disease (MRD)Negative Complete Response (CR) Per International Myeloma Working Group (IMWG) Criteria	70.4	—
SECONDARY Percentage of Participants That Have Minimal Residual Disease (MRD)-Negative Complete Response (CR) for a Minimum of 1 Year	63	—
SECONDARY Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)	54	—
SECONDARY Clinical Progression Free Survival	90.7	—
SECONDARY Biochemical Progression Free Survival	76.6	—
SECONDARY Duration of Response	7.9	—
SECONDARY Overall Response Rate	100; 5.5; 18.5; 0; 75.9	—

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.

Eligibility Criteria

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 10 g/dl
Absence of renal failure: serum creatinine 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 Grade 2 at the time of first dose or within 14 days of enrollment.

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations within 2 weeks that would limit compliance with study requirements.

History of other malignancy (apart from basal cell carcinoma of the skin, or in situ cervix carcinoma) except if the patient has been free of symptoms and without active therapy during at least 2 years or if, at the clinical discretion of the investigator, the risks of this study do not outweigh the potential benefits on a case to case basis.

Major surgery within 1 month prior to enrollment.

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Data sourced from ClinicalTrials.gov (NCT01572480). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.