relapsed and/or refractory multiple myeloma C90.0
Conditions
Interventions
Group 1: Pepaxti (Melflufen) + Dexamethasone according to marketing authorization administered as part of routine clinical practice
Sponsors
Oncopeptides AB
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The patient fulfils basic eligibility criteria as described in the observational plan 2. Be at least 18 years of age. 3. Ability to provide signed and dated informed consent. 4. Decision for treatment with the combination therapy melflufen and dexamethasone is made before inclusion in the study.
Exclusion criteria
Exclusion criteria: 1. Patients who are currently participating in any interventional clinical study (unless the patient only remains in survival follow-up). 2. Any assessment of effectiveness of ongoing melflufen treatment has been performed. 3. Previous treatment with melflufen, or ongoing treatment with melflufen has been longer than 28 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate (proportion of patients with =PR [sCR, CR, VGPR or PR] as best response) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Progression Free Survival (time from start of melflufen administration to confirmed disease progression or death) - Overall Survival (time from start of melflufen administration to death) - Duration Of Response (time from first confirmed response of = PR to confirmed disease progression, or death) - Best response (sCR, CR, VGPR, PR MR, SD, and PD) - Clinical Benefit Rate (proportion of patients with = MR [sCR, CR, VGPR, PR or MR]) as best response) - Time To Next Treatment (time from start of melflufen administration to initiation of first subsequent MM therapy) - Time To Progression (time from start of melflufen administration to confirmed disease progression) | — |
Countries
Germany
Outcome results
None listed