Multiple myeloma
Conditions
Brief summary
Enhancement of ORR (yes/no), defined as “yes” for patients that show an increase in ORR at Visit 15 (start of cycle 4) as compared to Visit 2 (baseline), and “no” otherwise.
Detailed description
Overall Response Rate (ORR, scores 1-7) defined as the highest class fulfilled by the patient at one time point: 1. PD, 2. SD or MR (SD, not fulfilling PD, MR, PR, VGPR or CR, or Minimal Response, ≥ 25% reduction in serum M-protein), 3.PR ≥ 50% reduction in serum M-protein, 4. VGPR ≥ 90% reduction in serum M-protein, 5. CR (Serum immunofixation not measurable), 6. Flow MRD negative, 7. Sustained MRD negative (compared to Visit 2), Treatment-emergent adverse events/serious adverse events (TEAEs/SAEs) (including IARs), Laboratory parameters, Vital signs, Weight, ECOG PS, Findings from physical examination
Interventions
Sponsors
Karolinska Institutet, Karolinska Institutet
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Enhancement of ORR (yes/no), defined as “yes” for patients that show an increase in ORR at Visit 15 (start of cycle 4) as compared to Visit 2 (baseline), and “no” otherwise. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Response Rate (ORR, scores 1-7) defined as the highest class fulfilled by the patient at one time point: 1. PD, 2. SD or MR (SD, not fulfilling PD, MR, PR, VGPR or CR, or Minimal Response, ≥ 25% reduction in serum M-protein), 3.PR ≥ 50% reduction in serum M-protein, 4. VGPR ≥ 90% reduction in serum M-protein, 5. CR (Serum immunofixation not measurable), 6. Flow MRD negative, 7. Sustained MRD negative (compared to Visit 2), Treatment-emergent adverse events/serious adverse events (TEAEs/SAEs) (including IARs), Laboratory parameters, Vital signs, Weight, ECOG PS, Findings from physical examination | — |
Countries
Sweden
Outcome results
None listed