Adults 18 to 75, any sex, with Multiple Myeloma in Relapse or Multiple Myeloma Progression. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Phase 1: Number of Participants With Dose Limiting Toxicities (DLT)Primary· Phase 1: From Day -1 up to 30 Days post-ASCT
DLT was defined as at least possibly related to tinostamustine based on common terminology criteria for adverse events 4.03 (CTCAE 4.03): (1) delayed engraftment (greater than \[\>\] 30 days after ASCT) where subject has not met criteria for both neutrophil (first of 3 consecutive days with ANC \> 0.5×10\^9/liter \[L\]) and platelet (plt) engraftment (first of 3 consecutive days of plt count \> 20×10\^9/L without plt transfusion in prior 7 days) (2) QTcF \> 500 millisecond (msec) or \> 60 msec increase from baseline with duration of \> 30 minutes or greater than or equal to (\>=) Grade 3 QTcF
Group
Value
95% CI
Tinostamustine 180 mg/m^2
0
Tinostamustine 220 mg/m^2
0
Phase 1 and 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)Secondary· From first dose of tinostamustine up to end of study (up to 6 months)
An Adverse Event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Serious adverse event (SAE) was defined as AE resulting in any of the following outcomes deemed significant for any other reason: death, was life-threatening (participant was at immediate risk of death from event as it occurred), requires in-patient hospitalization (formal admission to a hospital for medical reasons) or prolongation of existing hospitalizati
Participants with TEAEs
Group
Value
95% CI
Tinostamustine 180 mg/m^2
3
Tinostamustine 220 mg/m^2
3
Participants with TESAEs
Group
Value
95% CI
Tinostamustine 180 mg/m^2
1
Tinostamustine 220 mg/m^2
2
Phase 1 and 2: Change From Baseline in Clinical Serum Chemistry Tests: ElectrolytesSecondary· Baseline (Day -1), Day 100
Clinical serum chemistry tests included electrolytes i.e. bicarbonate, calcium, magnesium, chloride, glucose, phosphate, potassium, and sodium. Change from baseline in clinical serum chemistry tests i.e. electrolytes at Day 100 were reported.
Bicarbonate: Change at Day 100
Group
Value
95% CI
Tinostamustine 180 mg/m^2
-0.3
± 1.53
Tinostamustine 220 mg/m^2
-0.7
± 1.15
Calcium: Change at Day 100
Group
Value
95% CI
Tinostamustine 180 mg/m^2
0.0667
± 0.12332
Tinostamustine 220 mg/m^2
0.1167
± 0.07638
Chloride: Change at Day 100
Group
Value
95% CI
Tinostamustine 180 mg/m^2
-2.3
± 4.04
Tinostamustine 220 mg/m^2
-0.3
± 1.53
Glucose: Change at Day 100
Group
Value
95% CI
Tinostamustine 180 mg/m^2
-3.3121
± 4.01991
Tinostamustine 220 mg/m^2
-0.7771
± 2.69209
Magnesium: Change at Day 100
Group
Value
95% CI
Tinostamustine 180 mg/m^2
-0.0274
± 0.09501
Tinostamustine 220 mg/m^2
-0.0274
± 0.04750
Phosphate: Change at Day 100
Group
Value
95% CI
Tinostamustine 180 mg/m^2
-0.0969
± 0.26439
Tinostamustine 220 mg/m^2
-0.2046
± 0.29308
Potassium: Change at Day 100
Group
Value
95% CI
Tinostamustine 180 mg/m^2
0.20
± 0.265
Tinostamustine 220 mg/m^2
0.10
± 0.361
Sodium: Change at Day 100
Group
Value
95% CI
Tinostamustine 180 mg/m^2
-2.0
± 3.61
Tinostamustine 220 mg/m^2
-1.3
± 1.15
Phase 1 and 2: Change From Baseline in Clinical Serum Chemistry Tests: Liver Function ParametersSecondary· Baseline (Day -1), Day 100
Clinical serum chemistry tests included liver function parameters i.e. Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Aspartate aminotransferase, (AST) and Lactate dehydrogenase. Change from baseline in clinical serum chemistry tests i.e. liver function parameters at Day 100 were reported.
ALT: Change at Day 100
Group
Value
95% CI
Tinostamustine 180 mg/m^2
4.0
± 1.73
Tinostamustine 220 mg/m^2
0.3
± 3.06
ALP: Change at Day 100
Group
Value
95% CI
Tinostamustine 180 mg/m^2
10.7
± 6.81
Tinostamustine 220 mg/m^2
14.7
± 5.13
AST: Change at Day 100
Group
Value
95% CI
Tinostamustine 180 mg/m^2
3.0
± 1.00
Tinostamustine 220 mg/m^2
2.0
± 4.36
Lactate dehydrogenase: Change at Day 100
Group
Value
95% CI
Tinostamustine 180 mg/m^2
-21.0
± 11.31
Tinostamustine 220 mg/m^2
4.0
± 2.83
Phase 1 and 2: Change From Baseline in Clinical Serum Chemistry Tests: Renal Function ParametersSecondary· Baseline (Day -1), Day 100
Clinical serum chemistry tests included renal function parameters i.e. creatinine and bilirubin. Change from baseline in clinical serum chemistry tests i.e. renal function parameters at Day 100 were reported.
Creatinine: Change at Day 100
Group
Value
95% CI
Tinostamustine 180 mg/m^2
14.1440
± 18.71075
Tinostamustine 220 mg/m^2
25.6360
± 8.43282
Bilirubin: Change at Day 100
Group
Value
95% CI
Tinostamustine 180 mg/m^2
-1.710
± 3.4200
Tinostamustine 220 mg/m^2
-3.420
± 6.1655
Direct Bilirubin: Change at Day 100
Group
Value
95% CI
Tinostamustine 180 mg/m^2
0.855
± 1.2092
Tinostamustine 220 mg/m^2
-3.420
± NA
Indirect Bilirubin: Change at Day 100
Group
Value
95% CI
Tinostamustine 180 mg/m^2
0.855
± 1.2092
Tinostamustine 220 mg/m^2
-6.840
± NA
Phase 1 and 2: Change From Baseline in Clinical Serum Chemistry Tests: Total ProteinSecondary· Baseline (Day -1), Day 100
Clinical serum chemistry tests included total protein. Change from baseline in clinical serum chemistry tests i.e. total protein at Day 100 were reported.
Group
Value
95% CI
Tinostamustine 180 mg/m^2
13.67
± 11.372
Tinostamustine 220 mg/m^2
30.13
± 32.309
Phase 1 and 2: Time to Reach Maximum Plasma Concentration (Tmax) of Tinostamustine and Its MetabolitesSecondary· Pre-infusion, 0.50, 0.75, 1, 3, 6, 24, 48 hours post-infusion
Tmax was defined as time to reach maximum plasma concentration. Tinostamustine (EDO-S101) and its metabolites included M2-EDO-S101 and M8-EDO-S101.
EDO-S101
Group
Value
95% CI
Tinostamustine 180 mg/m^2
0.75
0.50 – 0.75
Tinostamustine 220 mg/m^2
0.75
0.50 – 0.75
M2-EDO-S101
Group
Value
95% CI
Tinostamustine 180 mg/m^2
1.00
1.00 – 1.00
Tinostamustine 220 mg/m^2
1.00
0.75 – 3.00
M8-EDO-S101
Group
Value
95% CI
Tinostamustine 180 mg/m^2
0.75
0.50 – 0.75
Tinostamustine 220 mg/m^2
1.00
0.50 – 1.00
Phase 1 and 2: Maximum Observed Plasma Concentration (Cmax) of Tinostamustine and Its MetabolitesSecondary· Pre-infusion, 0.50, 0.75, 1, 3, 6, 24, 48 hours post-infusion
Cmax was defined as maximum observed plasma concentration. Tinostamustine (EDO-S101) and its metabolites included M2-EDO-S101 and M8-EDO-S101.
EDO-S101
Group
Value
95% CI
Tinostamustine 180 mg/m^2
2270
± 910
Tinostamustine 220 mg/m^2
3070
± 1320
M2-EDO-S101
Group
Value
95% CI
Tinostamustine 180 mg/m^2
2.85
± 1.45
Tinostamustine 220 mg/m^2
2.23
± 0.633
M8-EDO-S101
Group
Value
95% CI
Tinostamustine 180 mg/m^2
52.4
± 4.58
Tinostamustine 220 mg/m^2
60.4
± 11.5
Phase 1 and 2: Area Under the Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUC0-t) of Tinostamustine and Its MetabolitesSecondary· Pre-infusion, 0.50, 0.75, 1, 3, 6, 24, 48 hours post-infusion
AUC0-t was defined as area under the concentration-time curve from time zero to the last measurable concentration. Tinostamustine (EDO-S101) and its metabolites included M2-EDO-S101 and M8-EDO-S101.
EDO-S101
Group
Value
95% CI
Tinostamustine 180 mg/m^2
2858.44
± 1475.82
Tinostamustine 220 mg/m^2
4922.66
± 2056.86
M2-EDO-S101
Group
Value
95% CI
Tinostamustine 180 mg/m^2
NA
± NA
Tinostamustine 220 mg/m^2
6.65
± 3.75
M8-EDO-S101
Group
Value
95% CI
Tinostamustine 180 mg/m^2
60.42
± 20.36
Tinostamustine 220 mg/m^2
100.75
± 20.01
Phase 1 and 2: Area Under the Concentration-time Curve From Time Zero to 12 Hours (AUC0-12h) of Tinostamustine and Its MetabolitesSecondary· Pre-infusion, 0.50, 0.75, 1, 3, 6 hours post-infusion
AUC0-12h was defined as area under the concentration-time curve from time zero to 12 hours. Tinostamustine (EDO-S101) and its metabolites included M2-EDO-S101 and M8-EDO-S101.
EDO-S101
Group
Value
95% CI
Tinostamustine 180 mg/m^2
NA
± NA
Tinostamustine 220 mg/m^2
4887.16
± 2052.21
Adverse events — posted to ClinicalTrials.gov
Time frame: From first dose of tinostamustine up to end of study (up to 6 months).
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Phase 1
The primary objectives of Phase 1 of this study are to:
* Establish the safety, toxicity, and maximum tolerated dose (MTD) of the tinostamustine conditioning regimen.
* Identify the recommended Phase 2 dose (RP2D) of tinostamustine for use in the Phase 2 portion of the study.
The secondary objective of Phase 1 of this study is to:
\- Investigate the pharmacokinetics (PK) of tinostamustine.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05432375 — Study of Tinostamustine for Adjuvant Treatment of Glioblastoma
· EARLY_PHASE1
· completed
NCT03903458 — Tinostamustine and Nivolumab in Advanced Melanoma
· Phase 1
· unknown
NCT03452930 — Tinostamustine With or Without Radiation Therapy in Treating Patients With Newly Diagnosed MGMT-Unmethylated Glioblastom
· Phase 1
· completed
NCT02576496 — Study of Tinostamustine, First-in-Class Alkylating HDACi Fusion Molecule, in Relapsed/Refractory Hematologic Malignancie
· Phase 1
· completed
Other recruiting trials for Multiple Myeloma in Relapse
Currently open trials in the same condition.
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· Phase 2
· recruiting
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· Phase 2
· recruiting
NCT07032129 — Sequential CAR-T Cells Targeting BCMA/GPRC5D in Patients With Relapsed/ Refractory Multiple Myeloma
· Phase 1, PHASE2
· recruiting
NCT07248176 — Universal CAR-T Cell Therapy for MM
· NA
· recruiting
NCT06846905 — Cost-utility Analysis of Ambulatory Dose Escalation of Bispecific Antibodies in Multiple Myeloma.
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Mundipharma-EDO GmbH
Last refreshed: 18 June 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03687125.