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Carfilzomib, Lenalidomide, and Dexamethasone in High-Risk Smoldering Multiple Myeloma: Final Results from the NCI Phase 2 Pilot Study

Ola Landgren, MD, PhD
Memorial Sloan-Kettering Cancer Center
New York, NY, USA

12.18.14

Program: Oral and Poster Abstracts
Session: 653. Myeloma: Therapy, excluding Transplantation: Poster III
Ola Landgren, MD, PhD1,2, Mark Roschewski, MD2, Sham Mailankody, MD2*, Mary Kwok, MD2*, Elisabet E. Manasanch, MD3, Manisha Bhutani, MD2, Nishant Tageja, MD2*, Dickran Kazandjian, MD2*, Adriana Zingone, MD, PhD2*, Rene Costello2*, Debra Burton2*, Yong Zhang, MD, PhD2*, Peter Wu2*, George Carter, PA2*, Marcia Mulquin, RN2*, Diamond Zuchlinski, RN2*, Ashley Carpenter, RN2*, Verena Gounden, MD4*, Candice Morrison, NP2*, Irina Maric, MD4, Katherine R. Calvo, M.D., Ph.D.4, Raul C. Braylan, MD4, Constance Yuan, MD, PhD5*, Maryalice Stetler-Stevenson, MD, PhD6, Diane C Arthur, MD5, Liza Lindenberg, MD7*, Kurdziel Karen, MD7*, Peter Choyke, MD7*, Seth M. Steinberg, PhD8*, William D Figg, PharmD9* and Neha Korde, MD1,2

1Myeloma Service, Division of Hematologic Oncology, Memorial Sloan-Kettering Cancer Center, New York, NY
2Multiple Myeloma Section, National Cancer Institute, National Institutes of Health, Bethesda, MD
3Lymphoma/Myeloma, M D Anderson Cancer Center, Houston, TX
4Department of Laboratory Medicine, Clinical Center, National Institutes of Health, Bethesda, MD
5Laboratory of Pathology, National Cancer Institute, National Institutes of Health, Bethesda, MD
6Laboratory of Pathology, Center for Cancer Research, National Cancer Institute, Bethesda, MD
7Molecular Imaging Program, National Cancer Institute, National Institutes of Health, Bethesda, MD
8Biostatistics and Data Management Section, National Cancer Institute, Bethesda, MD
9Clinical Pharmacology Program, Office of the Clinical Director, National Cancer Institute, Bethesda, MD

 
BACKGROUND: Early treatment with lenalidomide and dexamethasone delays progression and increases overall survival in patients with high-risk smoldering multiple myeloma. The addition of the selective proteasome inhibitor carfilzomib to a lenalidomide and dexamethasone backbone has proven effective in patients with newly-diagnosed multiple myeloma; this combination may allow patients with high-risk smoldering multiple myeloma to obtain deep and durable responses.

 

METHODS: In this phase 2 pilot study, patients with high-risk smoldering multiple myeloma received eight 28-day cycles of induction therapy with carfilzomib (at a dose of 20/36 mg per square meter on days 1, 2, 8, 9, 15, and 16), lenalidomide (at a dose of 25 mg on days 1–21), and dexamethasone (at a dose of 10 or 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23). Patients achieving stable disease or better after combination therapy received 2 years of maintenance therapy with lenalidomide. Minimal residual disease was assessed with multi-color flow cytometry, next-generation sequencing by the LymphoSIGHT method, and fluorodeoxyglucose-positron emission tomography-computed tomography (FDG-PET/CT). Myeloma clonotypes were identified in genomic DNA obtained from CD138+ bone marrow cell lysate or cell-free bone marrow aspirate at baseline for each patient based on their high frequency within the B-cell repertoire. Per study protocol, minimal residual disease assessment by next-generation sequencing, multi-color flow cytometry and FDG-PET/CT was repeated when patients achieved a complete response or completed 8 cycles of induction treatment. A sample size of 12 evaluable patients was calculated as being minimally necessary based on the following probability calculations: If the true probability of a very good partial response was 20% or 50%, we calculated that there would be a 7.3% or 80.6% probability, respectively, if 5 or more patients exhibiting a very good partial response (VGPR). Thus, if 5 or more patients out of 12 achieved a very good partial response, there would be strong evidence that the true probability of a VGPR was 50% or more.

 

RESULTS: Twelve patients were enrolled. All 11 patients (100%) who completed 8 cycles of combination therapy obtained VGPR or better (primary end point). Minimal residual disease assessment by next-generation sequencing was performed on bone marrow supernatant to detect cell-free myeloma clonotypes, while flow cytometry analysis utilized bone marrow cells. Overall (N=12), 100% of patients achieved a complete response or better over the study period, including 11 patients (92%) negative for minimal residual disease based on multi-color flow cytometry. Based on next-generation sequencing, two of the 12 patients were positive for minimal residual disease in the bone marrow supernatant; one of these two patients was also positive for minimal residual disease based on multi-color flow cytometry in the bone marrow cells. Information regarding longitudinal minimal residual disease status will be available and presented at the meeting. Adverse events were manageable.

 

CONCLUSIONS: Early treatment with carfilzomib, lenalidomide, and dexamethasone was associated with high rates of complete response and minimal residual disease negativity by multi-color flow cytometry, next-generation sequencing, and FDG-PET/CT in patients with high-risk smoldering multiple myeloma.


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  • ASH Oral and Posters Overview and High Risk Smoldering MM
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Social Media Team
ASH 2014 Social Media Team
Tune in as the IMF brings myeloma support group leaders and patients to San Francisco for the 56th annual meeting of the American Society of Hematology (ASH), an exciting convergence of 20,000 health care professionals from around the world. Start following the IMF ASH team members now on social media as they ramp up to share the latest clinical updates in myeloma research, therapies, and practice strategies via Twitter (#IMFASH2014), Facebook, blogs and videos.