Autopsy report · NCT02756728

A Phase I/II Study of BI-505 in Conjunction With Autologous Stem Cell Transplant in Multiple Myeloma

“Full clinical hold from FDA”

The sponsor’s own words in the registry.

Life of this trial

• Ran for about 7 months before it stopped.
• 5 participants enrolled.
• No results are posted on the registry.

Vital statistics

Status

Terminated

Phase

Phase 1, Phase 2

Sponsor

BioInvent International AB

Sponsor type

Industry

Conditions

Multiple Myeloma

Interventions

BI-505; High dose melphalan; Autologous stem cell transplantation

Participants

5

Sites

1

Countries

United States

Trials that died the same way

• Double-Blind, Placebo Controlled, Phase 3 Trial of ZGN-440 (Beloranib) in Obese Subjects With Prader-Willi Syndrome
  “FDA Clinical Hold” (95% match in meaning)
• DB289 Versus TMP-SMX for the Treatment of Acute Pneumocystis Jiroveci Pneumonia (PCP)
  “FDA Clinical Hold as of 12/21/07 due to safety concerns” (86% match in meaning)
• Safety of SP-420 in the Treatment of Transfusional Iron Overload
  “Study is on hold by FDA in the US.” (78% match in meaning)
• MAS-1 Adjuvanted Compared to Unadjuvanted Influenza Vaccines in the Elderly
  “FDA hold on the project” (74% match in meaning)
• The Use of Autologous Mesenchymal Stem Cell Preparation for Treatment of Refractory Migraine
  “Pending FDA approval” (69% 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.