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Daratumumab for first line treatment of transplant-ineligible myeloma patients followed by daratumumab re-treatment at first relapse (GMMG-DADA)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517761-17-00
Acronym
UNI-KOELN-3946
Enrollment
67
Registered
2024-10-24
Start date
2021-05-31
Completion date
Unknown
Last updated
2025-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Brief summary

Response (≥VGPR) after 8 cycles of DVCd

Detailed description

Minimal residual disease (MRD) negativity at any time before and during maintenance therapy (DVd) assessed by NGS at a level of 10e-5, Progression-free survival at 12 months from start of second line therapy, Progression-free survival from trial inclusion (PFS), Time to next treatment (TTNT), Overall survival (OS), Overall response rate of first line treatment, Overall response rate of second line treatment, Minimal residual disease (MRD) negativity at any time before and during maintenance therapy (DVd) assessed by NGS at other thresholds or by Flow

Interventions

DRUGDARZALEX 1800 mg solution for injection

Sponsors

University Of Cologne
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Response (≥VGPR) after 8 cycles of DVCd

Secondary

MeasureTime frame
Minimal residual disease (MRD) negativity at any time before and during maintenance therapy (DVd) assessed by NGS at a level of 10e-5, Progression-free survival at 12 months from start of second line therapy, Progression-free survival from trial inclusion (PFS), Time to next treatment (TTNT), Overall survival (OS), Overall response rate of first line treatment, Overall response rate of second line treatment, Minimal residual disease (MRD) negativity at any time before and during maintenance therapy (DVd) assessed by NGS at other thresholds or by Flow

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026