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NCT01572480: Phase 2: Carfilzomib, Lenalidomide, and Dexamethasone for Smoldering Multiple Myeloma

Updated: May 23, 2022

NCT01572480: Phase 2: Carfilzomib, Lenalidomide, and Dexamethasone for Smoldering Multiple Myeloma


krd smoldering myeloma

  • 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.


National Cancer Institute (NCI)

Information provided by (Responsible Party)

National Institutes of Health Clinical Center (CC)

( National Cancer Institute (NCI) ) Identifier: NCT01572480

Official Title: Carfilzomib, Lenalidomide, and Dexamethasone in High-Risk Smoldering Multiple Myeloma: a Clinical and Correlative Pilot Study

First Posted : April 6, 2012

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Carfilzomib, Lenalidomide, and Dexamethasone Followed by Lenalidomide Maintenance for Prevention of Symptomatic Multiple Myeloma in Patients With High-risk Smoldering Myeloma: A Phase 2 Nonrandomized Controlled Trial.

JAMA Oncol. 2021 Sep



548 Treatment of High Risk (HR) Smoldering Multiple Myeloma (SMM) with Carfilzomib, Lenalidomide, and Dexamethasone (KRd) Followed By Lenalidomide Maintenance (-R): A Phase 2 Clinical and Correlative Study

Program: Oral and Poster Abstracts

Diseases, smoldering myeloma, Plasma Cell Disorders, Lymphoid Malignancies

ASH 2020 ; Monday, December 7, 2020


Treatment of HR-SMM with KRd-R to prevent symptomatic MM resulted in an MRD negative CR rate of 70% with a median duration of 5.5 years. At the 5-year landmark, only 10% of patients developed MM which is favorable compared to historical rates with no treatment of ~75%. Alternative approaches using monotherapy lenalidomide (Lonial et al, JCO 2019) resulted in no CRs and a 5-year progression rate of 22% with a treatment discontinuation rate of 51% compared to 7% in our study. More aggressive approaches include GEM-CESAR (Mateos et al, ASH 2019) incorporating HDM-ASCT with KRd-R. Importantly, the rate of MRD negativity reported in GEM-CESAR was 56% compared to 70% in this study. Overall, the benefit compared to risk with KRd in SMM is very favorable. Future randomized trials will be needed to lock in this conclusion.


Bone marrow abnormalities and early bone lesions in multiple myeloma and its precursor disease: a prospective study using functional and morphologic imaging.

Leuk Lymphoma. 2016 May


Treatment With Carfilzomib-Lenalidomide-Dexamethasone With Lenalidomide Extension in Patients With Smoldering or Newly Diagnosed Multiple Myeloma.

JAMA Oncol. 2015 Sep



United States, Maryland


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