Autopsy report · NCT03757221

Ixazomib -Daratumumab Without Dexamethasone (IDara) in Elderly Relapse Refractory Multiple Myeloma

“Early termination (regarding the follow-up of the patients). The required sample size was reached, and the primary endpoint was met.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 2 months before it started.
• Ran for about 5 years 3 months before it stopped.
• 55 participants enrolled.
• No results are posted on the registry.

Vital statistics

Status

Terminated

Phase

Phase 2

Sponsor

University Hospital, Caen

Sponsor type

University, hospital or other

Conditions

Multiple Myeloma

Interventions

Ixazomib and Daratumumab

Participants

55

Sites

1

Countries

France

Trials that died the same way

• The Impact of IVIG Treatment on Critical Illness Polyneuropathy and/or Myopathy in Patients With MOF and SIRS/Sepsis
  “The trial was terminated early due to futility in reaching the primary endpoint.” (70% match in meaning)
• PFC Sigma Fixed and Mobile Knee Study
  “The study was terminated at the point the primary endpoint and early milestones were reached and because long term outcomes were available from other sources” (69% match in meaning)
• Study With Rituximab-Gemcitabine/Oxaliplatin in Relapsed Indolent Lymphoma
  “Predefined termination criterion of \> 10 patients without CR or PR was matched.” (68% match in meaning)
• Safety and Efficacy of Melatonin in Patients With Multiple Progressive Primary Sclerosis
  “Early termination due to operational feasibility reasons, resulting from a slow recruitment rate and logistical and financial difficulties that prevent reaching the planned sample size within the study schedule.” (67% match in meaning)
• Efficacy and Safety of Emapalumab and Anakinra in Reducing Hyperinflammation and Respiratory Distress in Patients With COVID-19 Infection.
  “Standard of care evolved during the timeframe of the study and had critical impact on recruitment. Early termination was not based on safety reasons but due to the reasons mentoined above. The ongoing patients were completed.” (67% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.