A non-interventional study of melphalan flufenamide (melflufen, Pepaxti) in combination with dexamethasone in patients with relapsed and/or refractory multiple myeloma (RRMM) according to the approved label.
Recruiting
- Conditions
- relapsed and/or refractory multiple myelomaC90.0Multiple myeloma
- Registration Number
- DRKS00033264
- Lead Sponsor
- Oncopeptides AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
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
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.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall Response Rate (proportion of patients with =PR [sCR, CR, VGPR or PR] as best response)
- Secondary Outcome Measures
Name Time Method - Progression Free Survival (time from start of melflufen administration to confirmed disease progression or death)<br>- Overall Survival (time from start of melflufen administration to death)<br>- Duration Of Response (time from first confirmed response of = PR to confirmed disease progression, or death) <br>- Best response (sCR, CR, VGPR, PR MR, SD, and PD)<br>- Clinical Benefit Rate (proportion of patients with = MR [sCR, CR, VGPR, PR or MR]) as best response) <br>- Time To Next Treatment (time from start of melflufen administration to initiation of first subsequent MM therapy)<br>- Time To Progression (time from start of melflufen administration to confirmed disease progression)<br>