Clinical trial · Interventional
Daratumumab as Maintenance After Peripheral Blood Stem Cell Transplantation From HLA-identical or Haploidentical Family Donor in the Treatment of Refractory or Relapsed Multiple Myeloma: a Phase 2 Trial
NCT04024384CI-TRIAL-00044291DARALLOwithdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Promotor decision
Summary
Brief summary (as posted)
The present protocol aims to test, whether an approach using (i) a reduced-toxicity TBF followed by a (ii) Daratumumab maintenance and (iii) prophylactic infusion of donor lymphocytes (pDLI), will be able to improve progression-free survival of patients with refractory or relapsed MM. This trial represents the first prospective protocol aiming to test the use of Daratumumab maintenance after HLA-identical or haploidentical allo-SCT in patients with MM.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Daratumumab | Drug | Daratumumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Daratumumab
- description
- Daratumumab as maintenance after peripheral blood stem cell transplantation from HLA-identical or haploidentical family donor in the treatment of refractory or relapsed multiple myeloma
- interventionNames
- Drug: Daratumumab
Primary outcomes (1)
- measure
- safety and efficacy of Daratumumab assessed by free survival
- timeFrame
- 1-year progression free survival in such patients
- description
- The primary objective is to assess the 1-year progression free survival in such patients. If the smallest response proportion (pnew=0.4) could be achieved compare to the lowest response probability of interest (phypo=0.2), the treatment strategy would worth to be developed further.
Secondary outcomes (10)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed diagnosis of multiple myeloma * Disease who progressed on salvage therapy or progressed within 60 days of the last treatment in patients who previously achieved at least a minimal response to treatment * Stable disease or better 1 month before transplantation * Age \> 18 and \< 70 years. * Availability of an HLA-haploidentical or HLA-identical family donor * Written informed consent. Exclusion Criteria: * Presence in the patient of donor HLA-specific antibodies (DSA) directed against the HLA haplo-identical family donor * Karnofsky score \<70% * HIV positive patient, chronic or active Hepatitis B or Hepatitis C * Life expectancy less than one month according to the attending physician * Acute or chronic heart failure (Cardiac ejection fraction \< 40%) * Pulmonary function - diffusion capacity \< 50% predicted * Estimated glomerular filtration rate \< 30 ml/min (CKD-EPI) * Severe neurological or psychiatric disorders * Any circumstances that preclude the use of the drugs used within the protocol * Prior allogeneic stem cell transplantation * Pregnancy or denied of effective contraceptive method
References
Publications (0)
Data not yet available
No reference posted for this study.