Latest & Greatest
cells demonstrated a clinical response in
80 percent of multiple myeloma patients
with advanced disease who had undergone autologous stem cell transplants
(ASCT).
The phase I/II clinical trial included
20 patients who received an average of
2.4 billion NY-ESO-engineered CD3 Tcell two days after ASCT. After a median
follow-up of 21.1 months, 15 patients
were alive, and 10 patients remained
progression-free; at 30.1 months of
follow-up, the median progressionfree survival was 19.1 months and
the median overall survival was 32.1
months. In addition, 14 patients (70%)
had near complete responses, while two
had a very good partial response. The
researchers noted that the response rate
was better than would be expected for
standard ASCT.
“This study suggests that treatment
with engineered T cells is not only
safe but of potential clinical benefit to
patients with certain types of aggressive
[MM],” said Aaron P. Rapoport, MD,
the director of the blood and marrow
transplant program at the University of
Maryland Marlene and Stewart Greenebaum Cancer Center, in a news release.
Source: Rapoport A, Stadtmauer EA, Binder-Scholl GK, et al.
NY-ESO-1–specific TCR–engineered T cells mediate sustained
antigen-specific antitumor effects in myeloma. Nat Med.
2015;21:914-21.
Proof-of-Concept
Study Shows Blood
Samples Safely Delivered Via Drone
Researchers at Johns Hopkins University School of Medicine experimented
with the concept of using drones to
deliver blood samples. A total of 336
T:7”
without a dose reduction, 50% in the REVLIMID/dexamethasone
treatment group had at least one additional dose interruption with or
without a dose reduction compared to 21% in the placebo/dexamethasone
treatment group. Most adverse reactions and Grade 3/4 adverse reactions
were more frequent in patients who received the combination of
REVLIMID/dexamethasone compared to placebo/dexamethasone.
Table 5: Adverse Reactions Reported in ≥5% of Patients and with a
≥2% Difference in Proportion of Patients Between the
REVLIMID/dexamethasone and Placebo/dexamethasone Groups
System Organ Class/ Preferred Term REVLIMID/Dex* Placebo/Dex *
(N=353)
(N=350)
n (%)
n (%)
Tables 5, 6, and 7 summarize the adverse reactions reported for
REVLIMID/dexamethasone and placebo/dexamethasone groups.
Metabolism and nutrition disorders
Anorexia
Hypokalemia
Hypocalcemia
Appetite Decreased
Dehydration
Hypomagnesemia
Investigations
Weight Decreased
Eye disorders
Blurred vision
Vascular disorders
Deep vein thrombosis%
Hypertension
Hypotension
55 (15.6)
48 (13.6)
31 (8.8)
24 (6.8)
23 (6.5)
24 (6.8)
34 (9.7)
21 (6.0)
10 (2.9)
14 (4.0)
15 (4.3)
10 (2.9)
69 (19.5)
52 (14.9)
61 (17.3)
40 (11.4)
33 (9.3)
28 (7.9)
25 (7.1)
15 (4.3)
20 (5.7)
15 (4.3)
Table 6: Grade 3/4 Adverse Reactions Reported in ≥2% Patients
and With a ≥1% Difference in Proportion of Patients Between the
REVLIMID/dexamethasone and Placebo/dexamethasone groups
System Organ Class/ Preferred Term REVLIMID/Dex# Placebo/Dex#
(N=353)
(N=350)
n (%)
n (%)
Blood and lymphatic system disorders
Neutropenia%
118 (33.4)
12 (3.4)
Thrombocytopenia@
43 (12.2)
22 (6.3)
Anemia@
35 (9.9)
20 (5.7)
Leukopenia
14 (4.0)
1 (0.3)
Lymphopenia
10 (2.8)
4 (1.1)
Febrile Neutropenia%
8 (2.3)
0 (0.0)
General disorders and administration site conditions
Fatigue
23 (6.5)
17 (4.9)
Vascular disorders
Deep vein thrombosis%
29 (8.2)
12 (3.4)
Infections and infestations
Pneumonia@
30 (8.5)
19 (5.4)
Urinary Tract Infection
5 (1.4)
1 (0.3)
Metabolism and nutrition disorders
Hypokalemia
17 (4.8)
5 (1.4)
Hypocalcemia
13 (3.7)
6 (1.7)
Hypophosphatemia
9 (2.5)
0 (0.0)
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism@
14 (4.0)
3 (0.9)
Respiratory Distress@
4 (1.1)
0 (0.0)
Musculoskeletal and connective tissue disorders
Muscle weakness
20 (5.7)
10 (2.9)
Gastrointestinal disorders
Diarrhea@
11 (3.1)
4 (1.1)
Constipation
7 (2.0)
1 (0.3)
Nausea@
6 (1.7)
2 (0.6)
Cardiac disorders
Atrial fibrillation@
13 (3.7)
4 (1.1)
Tachycardia
6 (1.7)
1 (0.3)
Cardiac Failure Congestive@
5 (1.4)
1 (0.3)
Nervous System disorders
Syncope
10 (2.8)
3 (0.9)
Dizziness
7 (2.0)
3 (0.9)
(continued)
Cosmos Communications
1
QC
T:10”
Table 5: Adverse Reactions Reported in ≥5% of Patients and with a
≥2% Difference in Proportion of Patients Between the
REVLIMID/dexamethasone and Placebo/dexamethasone Groups
System Organ Class/ Preferred Term REVLIMID/Dex* Placebo/Dex *
(N=353)
(N=350)
n (%)
n (%)
Blood and lymphatic system disorders
Neutropenia %
149 (42.2)
22 (6.3)
Anemia@
11