Midostaurin + Chemotherapy
Treatment for Acute Myeloid Leukemia
Typical Dosage: Midostaurin 50 mg orally twice daily, Days 8-21 of induction/consolidation, then continuously
Effectiveness
77%
Safety Score
30%
Clinical Trials
23
Participants
1.5K
Comparative Safety Scale(Higher is safer)
Cyanide☠️
Meth💀
Cigarettes🚬
Chemo☢️
Alcohol🍺
Morphine💊
Antibiotics💉
Tylenol💊
Exercise🏃
Water💧
30
DangerousModerateSafe
Treatment Details
Dosage Range
Midostaurin 50 mg orally twice daily, Days 8-21 of induction/consolidation, then continuously
Time to Effect
Starts with chemotherapy, effects seen with prolonged remission
Treatment Duration
Concurrent with induction/consolidation, then maintenance for up to 12 months
Evidence Quality
HIGHNumber Needed to Treat (NNT)
10(Treat 10 patients to see 1 additional successful outcome)
Confidence Score
90%confidence in effectiveness data
Health Economics
Annual Cost of Care
Drug Cost:$185,000
Monitoring:$150,000
Side Effect Mgmt:$75,000
Total Annual:$410,000
Cost-Effectiveness Analysis
Cost-Effectiveness Rating
POORICER
$179,000/QALY
QALYs Gained
2.7
Outcome-Based Costs
Cost per Responder
$630,769
Cost per Remission
$630,769
Comparison vs 7+3 Chemotherapy (placebo arm)
Cost Difference
+$180,000/year
More expensive
QALY Difference
+0.30 QALYs
Better outcomes
Dominance
No dominance
Midostaurin + Chemotherapy Outcomes
for Acute Myeloid Leukemia
Efficacy Outcomes
Overall Effectiveness
+77%
Response Rate
+65%
Remission Rate
+65%
Common Side Effects
Nausea/Vomiting
+80%
Diarrhea
+50%
Headache
+25%
Febrile neutropenia
+85%
Active Clinical Trials
6 active trials recruiting for Midostaurin + Chemotherapy in Acute Myeloid Leukemia
Combination of Midostaurin and Gemtuzumab Ozogamicin in First-line Standard Therapy for Acute Myeloid Leukemia (MOSAIC)
NCT04385290RECRUITINGPHASE1, PHASE2
214 participants
INTERVENTIONAL
München, Germany +20 more
Started: Sep 4, 2020
A Study of Gilteritinib Versus Midostaurin in Combination With Induction and Consolidation Therapy Followed by One-year Maintenance in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndromes With Excess Blasts-2 With FLT3 Mutations Eligible for Intensive Chemotherapy
NCT04027309ACTIVE NOT RECRUITINGPHASE3
777 participants
INTERVENTIONAL
Adelaide, Australia +192 more
Started: Dec 20, 2019
A Global Study of Midostaurin in Combination With Chemotherapy to Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML
NCT03591510ACTIVE NOT RECRUITINGPHASE2
22 participants
INTERVENTIONAL
Prague, Czechia +15 more
Started: Mar 13, 2019
Revumenib in Combination With 7+3 + Midostaurin in AML
NCT06313437RECRUITINGPHASE1
22 participants
INTERVENTIONAL
Boston, United States +1 more
Started: Dec 6, 2024
Dexamethasone Added to Intensive Chemotherapy in Older Patients with Acute Myeloid Leukemia (AML)
NCT03609060ACTIVE NOT RECRUITINGPHASE2
120 participants
INTERVENTIONAL
Angers, France +24 more
Started: Aug 24, 2018
Study of Iomab-B vs. Conventional Care in Older Subjects With Active, Relapsed or Refractory Acute Myeloid Leukemia
NCT02665065ACTIVE NOT RECRUITINGPHASE3
153 participants
INTERVENTIONAL
Gilbert, United States +23 more
Started: Jun 1, 2016
Completed Clinical Trials
6 completed trials for Midostaurin + Chemotherapy in Acute Myeloid Leukemia
A Global Study of the Efficacy and Safety of Midostaurin + Chemotherapy in Newly Diagnosed Patients With FLT3 Mutation Negative (FLT3-MN) Acute Myeloid Leukemia (AML)
NCT03512197COMPLETEDPHASE3
511 participants
INTERVENTIONAL
Chicago, United States +132 more
Started: Jul 20, 2018
Trial to Assess the Efficacy of Midostaurin (PKC412) in Patients With c-KIT or FLT3-ITD Mutated t(8;21) AML
NCT01830361COMPLETEDPHASE2
18 participants
INTERVENTIONAL
Chemnitz, Germany +9 more
Started: Mar 13, 2013
Protocol in Acute Myeloid Leukemia With FLT3-ITD
NCT01477606COMPLETEDPHASE2
451 participants
INTERVENTIONAL
Innsbruck, Austria +54 more
Started: May 1, 2012
Study to Assess the Safety and Efficacy of Midostaurin (PKC412) in Combination With Standard Chemotherapy During Induction and Consolidation Followed by 12 Months of Maintenance Monotherapy in Patients With Newly-diagnosed FMS-like Tyrosine 3 (FLT3) Kinase Receptor-mutated Acute Myeloid Leukemia.
NCT03379727COMPLETEDPHASE3
301 participants
INTERVENTIONAL
Pleven, Bulgaria +85 more
Started: Feb 13, 2018
Phase I Combination of Midostaurin, Bortezomib, and Chemo in Relapsed/Refractory Acute Myeloid Leukemia
NCT01174888COMPLETEDPHASE1
34 participants
INTERVENTIONAL
Columbus, United States
Started: Aug 1, 2010
Azacitidine With or Without Nivolumab or Midostaurin, or Decitabine and Cytarabine Alone in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
NCT03092674COMPLETEDPHASE2, PHASE3
76 participants
INTERVENTIONAL
Anchorage, United States +505 more
Started: Feb 2, 2018
Showing 20 of 23 total trials