CLINICAL NEWS
be to ask, “Well, how are we going to get
paid for it, if insurance companies aren’t
covering it yet?”
In that way, we’re hoping that this
session will be more in tune with the
audience members who come to educa-
tion sessions – trainees or people new
to hematology/oncology who want to
expand their understanding of a certain
disease topic.
APPROACH TO THE TREATMENT OF THE YOUNG, FIT PATIENT WITH MYELOMA:
FROM DIAGNOSIS TO RELAPSE
Saturday, December 1, 2018
Session offered twice: 9:30 a.m. - 11:00 a.m. and 4:00 p.m. - 5:30 p.m.
San Diego Convention Center, Ballroom 20A APPROACH TO THE TREATMENT OF THE OLDER, UNFIT PATIENT WITH
MYELOMA: FROM DIAGNOSIS TO RELAPSE
Saturday, December 1, 2018
Session offered twice: 7:30 a.m. - 9:00 a.m. and 2:00 p.m. - 3:30 p.m.
San Diego Convention Center, Ballroom 20A
Chair:
Eric Seifter, MD, Johns Hopkins University School of Medicine, Baltimore, MD Chair:
Kenneth C. Anderson, MD, Dana-Farber Cancer Institute, Harvard Medical School,
Boston, MA
Speakers:
Saad Z. Usmani, MD, Levine Cancer Institute, Charlotte, NC
Sergio A. Giralt, MD, Memorial Sloan Kettering Cancer Center, New York, NY
Speakers:
Thierry Facon, MD. Hôpital Claude Huriez, Lille, France
Tanya Wildes, MD, Washington University, Saint Louis, MO
REVLIMID [lenalidomide] capsules, for oral use
Table 5: All Adverse Reactions in ≥5.0% and Grade 3/4 Adverse Reactions in ≥ 1.0% of Patients in the REVLIMID Vs Placebo Arms*
Maintenance Study 1
Body System
Adverse Reaction
All Adverse Reactions [a]
REVLIMID
(N=224)
n (%)
Placebo
(N=221)
n (%)
Maintenance Study 2
Grade 3/4 Adverse
Reactions [b]
REVLIMID
(N=224)
n (%)
Placebo
(N=221)
n (%)
All Adverse Reactions [a]
REVLIMID
(N=293)
n (%)
Placebo
(N=280)
n (%)
Grade 3/4 Adverse
Reactions [b]
REVLIMID
(N=293)
n (%)
Placebo
(N=280)
n (%)
Nervous system disorders
Paresthesia e
2 ( 0.9) 0 ( 0.0) 0 ( 0.0) 0 ( 0.0) 39 ( 13.3) 30 ( 10.7) 1 ( 0.3) 0 ( 0.0)
Peripheral neuropathy* e 34 ( 15.2) 30 ( 13.6) 8 ( 3.6) 8 ( 3.6) 29 ( 9.9) 15 ( 5.4) 4 ( 1.4) 2 ( 0.7)
Headache d 11 ( 4.9) 8 ( 3.6) 5 ( 2.2) 1 ( 0.5) 25 ( 8.5) 21 ( 7.5) 0 ( 0.0) 0 ( 0.0)
Alanine aminotransferase
increased 16 ( 7.1) 3 ( 1.4) 8 ( 3.6) 0 ( 0.0) 5 ( 1.7) 5 ( 1.8) 0 ( 0.0) 1 ( 0.4)
Aspartate aminotransferase
increased d 13 ( 5.8) 5 ( 2.3) 6 ( 2.7) 0 ( 0.0) 2 ( 0.7) 5 ( 1.8) 0 ( 0.0) 0 ( 0.0)
Hypokalemia 24 ( 10.7) 13 ( 5.9) 16 ( 7.1) 12 ( 5.4) 12 ( 4.1) 1 ( 0.4) 2 ( 0.7) 0 ( 0.0)
Dehydration 9 ( 4.0 ) 5 ( 2.3) 7 ( 3.1) 3 ( 1.4) 0 ( 0.0) 0 ( 0.0) 0 ( 0.0) 0 ( 0.0)
16 ( 7.1) 15 ( 6.8) 13 ( 5.8) 14 ( 6.3) 0 ( 0.0) 1 ( 0.4) 0 ( 0.0) 0 ( 0.0)
0 ( 0.0)
Investigations
Metabolism and nutrition disorders
Hypophosphatemia d
Musculoskeletal and connective tissue disorders
Muscle spasms e 0 ( 0.0) 1 ( 0.5) 0 ( 0.0) 0 ( 0.0) 98 ( 33.4) 43 ( 15.4) 1 ( 0.3) Myalgia e 7 ( 3.1) 8 ( 3.6) 3 ( 1.3) 5 ( 2.3) 19 ( 6.5) 12 ( 4.3) 2 ( 0.7) 1 ( 0.4)
Musculoskeletal pain e 1 ( 0.4) 1 ( 0.5) 0 ( 0.0) 0 ( 0.0) 19 ( 6.5) 11 ( 3.9) 0 ( 0.0) 0 ( 0.0)
34 ( 15.2) 19 ( 8.6) 4 ( 1.8) 2 ( 0.9) 4 ( 1.4) 1 ( 0.4) 2 ( 0.7) 0 ( 0.0)
23 ( 10.3) 12 ( 5.4) 3 ( 1.3) 1 ( 0.5) 80 ( 27.3) 56 ( 20.0) 0 ( 0.0) 0 ( 0.0)
0 ( 0.0)
Hepatobiliary disorders
Hyperbilirubinemia e
Respiratory, thoracic and mediastinal disorders
Cough e
Dyspnea
c e
15 ( 6.7) 9 ( 4.1) 8 ( 3.6) 4 ( 1.8) 17 ( 5.8) 9 ( 3.2) 2 ( 0.7) Rhinorrhea e 0 ( 0.0) 3 ( 1.4) 0 ( 0.0) 0 ( 0.0) 15 ( 5.1) 6 ( 2.1) 0 ( 0.0) 0 ( 0.0)
Pulmonary embolism c d e 0 ( 0.0) 0 ( 0.0) 0 ( 0.0) 0 ( 0.0) 3 ( 1.0) 0 ( 0.0) 2 ( 0.7) 0 ( 0.0)
8 ( 3.6) 2 ( 0.9) 5 ( 2.2) 2 ( 0.9) 7 ( 2.4) 1 ( 0.4) 4 ( 1.4) 1 ( 0.4)
Vascular disorders
Deep vein thrombosis* c d %
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome c d e
5 ( 2.2)
0 ( 0.0)
2 ( 0.9)
0 ( 0.0)
3 ( 1.0)
0 ( 0.0)
1 ( 0.3)
0 ( 0.0)
Note: AEs are coded to body system /adverse reaction using MedDRA v15.1. A subject with multiple occurrences of an AE is counted only once in each
AE category.
a All treatment-emergent AEs in at least 5% of patients in the Lenalidomide Maintenance group and at least 2% higher frequency (%) than the Placebo
Maintenance group.
b All grade 3 or 4 treatment-emergent AEs in at least 1% of patients in the Lenalidomide Maintenance group and at least 1% higher frequency (%) than the
Placebo Maintenance group.
c All serious treatment-emergent AEs in at least 1% of patients in the Lenalidomide Maintenance group and at least 1% higher frequency (%) than the Placebo
Maintenance group.
d Footnote “a” not applicable for either study
e Footnote “b” not applicable for either study
@ -ADRs where at least one resulted in a fatal outcome
% - ADRs where at least one was considered to be Life Threatening (if the outcome of the event was death, it is included with death cases)
# - All adverse reactions under Body System of Infections and Infestation except for rare infections of Public Health interest will be considered listed
*Adverse Reactions for combined ADR terms (based on relevant TEAE PTs included in Maintenance Studies 1 and 2 [per MedDRA v 15.1]):
Pneumonias Bronchopneumonia,. Lobar pneumonia, Pneumocystis jiroveci pneumonia, Pneumonia, Pneumonia klebsiella, Pneumonia legionella, Pneumonia
mycoplasmal, Pneumonia pneumococcal, Pneumonia streptococcal, Pneumonia viral, Lung disorder, Pneumonitis
Sepsis: Bacterial sepsis, Pneumococcal sepsis, Sepsis, Septic shock, Staphylococcal sepsis
Peripheral neuropathy: Neuropathy peripheral, Peripheral motor neuropathy, Peripheral sensory neuropathy, Polyneuropathy
Deep vein thrombosis: Deep vein thrombosis, Thrombosis, Venous thrombosis