Median Progression-Free Survival (PFS)
Rd Continuous (n=535) 25.5 mo (95% CI 20.7, 29.4)
Rd18
(n=541) 20.7 mo (95% CI 19.4, 22.0)
MPT
(n=547) 21.2 mo (95% CI 19.3, 23.2)
100
Survival Probability (%)
80
Rd Continuous vs MPT
Rd Continuous vs Rd18
Rd18 vs MPT
60
HR (95% CI)
Logrank P value (2-sided)
0.72 (0.61, 0.85) P<0.0001
0.70 (0.60, 0.82)
1.03 (0.89, 1.20)
Planned duration of
treatment in the Rd18
40 and MPT arms was
18 months
20
0
0
1
2
3
4
5
Progression-Free Survival (Years)
•535
PFS
Rd Continuous
Rd18
541
MPT MM-020
547
Study design: The
Events:
(52.0%),
(64.3%), MPT=334/547
400Rd Continuous=278/535
319
265
218 Rd18=348/541
168
105
55
19 (61.1%)2
391
380
(FIRST)
319
265
167
304
244
compared
REVLIMID170+
108
116
low-dose
56
30
58
28 (Rd)
dexamethasone
7
2
6
1
Continuous
until
0
0
0
progression,
trial
fixed-cycle
MPT, and fixed-cycle Rd18. MM-020 was a Phase 3, randomized, multicenter, open-label, 3-arm study enrolling 1623 newly diagnosed
Number
of Subjects
at mg
Risk
patients who did not receive a stem cell transplant (SCT).
REVLIMID
was given 25
once daily orally on Days 1 to 21 of 28-day cycles,
PFS
Events:
Rd
Continuous=278/535
(52.0%),
Rd18=348/541
(64.3%),
MPT=334/547
(61.1%) ≤75 years and 20 mg for patients
and dex was dosed once daily orally on Days 1, 8, 15, and 22 of each 28-day cycle (40 mg for patients
>75 years). The primary endpoint in the trial was progression-free survival (PFS), as the time from randomization to the first documentation
of disease progression as determined by Independent Response Adjudication Committee (IRAC), based on International Myeloma Working
Group (IMWG) criteria, or death due to any cause, whichever occurred first during the study until the end of the PFS follow-up phase. For
the efficacy analysis of all endpoints, the primary comparison was between Rd Continuous and MPT arms.
58.9 months median overall survival (OS) with Rd Continuous until progression in
an interim analysis, compared with 48.5 months with MPT (HR 0.75 [95% CI 0.62, 0.90])
and 56.7 months with Rd18 (HR 0.91 [95% CI 0.75, 1.09])
• At median follow-up of 45.5 months, only 78% of prespecified events had occurred (697/896
of the final OS events)
• OS is defined as the time from randomization to death from any cause
ADVERSE REACTIONS
Multiple Myeloma
• In newly diagnosed patients the most frequently reported Grade 3 or 4 adverse reactions in Arm Rd Continuous included neutropenia
(27.8%), anemia (18.2%), thrombocytopenia (8.3%), pneumonia (11.3%), asthenia (7.7.%), fatigue (7.3%), back pain (7%), hypokalemia
(6.6%), rash (7.3%), cataract (5.8%), dyspnea (5.6%), DVT (5.6%), hyperglycemia (5.3%), lymphopenia and leukopenia. The frequency of
infections in Arm Rd Continuous was 75%
Adverse reactions reported in ≥20% of NDMM patients in Arm Rd Continuous: diarrhea (45.5%), anemia (43.8%), neutropenia (35%),
fatigue (32.5%), back pain (32%), insomnia (27.6%), asthenia (28.2%), rash (26.1%), decreased appetite (23.1%), cough (22.7%),
pyrexia (21.4%), muscle spasms (20.5%), and abdominal pain (20.5%). The frequency of onset of cataracts increased over time with
0.7% during the first 6 months and up to 9.6% by the second year of treatment with Arm Rd Continuous
CONTRAINDICATIONS
Pregnancy: REVLIMID can cause fetal harm when administered to a pregnant female and is contraindicated in females who are
pregnant. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be
apprised of the potential hazard to the fetus
Allergic Reactions: REVLIMID is contraindicated in patients who have demonstrated hypersensitivity (e.g., angioedema, StevensJohnson syndrome, toxic epidermal necrolysis) to lenalidomide
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