Optimal Use of Newly Approved Agents – Carfilzomib and Pomalidomide Lymphoma-Myeloma Symposium October 2013 Scottsdale, Arizona Scottsdale, Arizona Rochester, Minnesota Rochester, Minnesota Jacksonville, Florida Jacksonville, Florida Joseph Mikhael, MD, MEd, FRCPC, FACP Staff Hematologist, Mayo Clinic Arizona
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Optimal Use of Newly Approved Agents – Carfilzomib and Pomalidomide Lymphoma-Myeloma Symposium October 2013 Scottsdale, Arizona Rochester, Minnesota Jacksonville,
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Optimal Use of Newly Approved Agents – Carfilzomib and Pomalidomide
•Assessments on D1 and 15 of C1 and D1 thereafter using modified IMWG Criteria with nCR•Cycles 1–8
• CFZ Days 1–2, 8–9, 15–16 at assigned doses1
• LEN 25 mg Days 1–21• DEX 40 mg weekly Cycles 1-4, 20 mg weekly Cycles 5–8
•Cycles 9–24• CFZ on Days 1–2 and 15–16 only• CFZ, LEN, DEX at last best tolerated doses•After Cycle 4, pts could undergo stem cell collection and then continue CRd with the
option to proceed to ASCT
Until disease progression or unacceptable toxicity
Treatment Schema
1. Jakubowiak AJ, et al. Blood. 2011;118: abstract 631. ASCO 2012 Slides courtesy of Dr. Jakubowiak
Responses
51%
Change from baseline
67%
81%
Pat
ien
ts (
%)
N= 53; median 12 cycles (range 1–25)
Initial Response Best Response
ASCO 2012 Slides courtesy of Dr. Jakubowiak
Results From the Phase II Dose Expansion of Cyclophosphamide, Carfilzomib, Thalidomide and
Dexamethasone (CYCLONE) in Patients with Newly Diagnosed Multiple Myeloma
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J. Mikhael, C. Reeder, E. Libby, L. Costa, A. Mayo, L. Bergsagel, F. Buadi, N. Pirooz, J. Lubben, AC. Dueck, AK. Stewart
Thromboprophylaxis was indicated for those receiving POM or with DVT history
*Progression of disease was independently adjudicated in real-timeDimopoulos Blood 2012, 120(21): LBA-6
MM-003: Key Eligibility Criteria• All pts had to be refractory to last therapy
• At least 2 prior therapies• ≥ 2 consecutive cycles of LEN and BORT (alone or in combination)
• Adequate prior alkylator therapy (SCT or ≥ 6 cycles or PD following ≥ 2 cycles)
• All pts must have failed LEN and BORT • Pt progressed on or within 60 days
• Pt with PR must have progressed within 6 months
• Intolerant to BORT
• Refractory or relapsed and refractory disease• Primary refractory: never achieved > PD to any therapy
• Relapsed and refractory: relapsed after having achieved ≥ SD for ≥ 2 cycles of Tx to at least one prior regimen and then developed PD ≤ 60 days of completing their last therapy