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NCT01102426 · ClinicalTrials.gov registry record · Phase 3

Aplidin - Dexamethasone in Relapsed/Refractory Myeloma

A Phase 3 study of Relapsed/Refractory Multiple Myeloma, sponsored by PharmaMar.

Completed
Registry status
Phase 3
Development phase
255
Enrollment target
20
Study locations

NCT01102426: Completed Phase 3 study of Relapsed/Refractory Multiple Myeloma, sponsored by PharmaMar.

NCT01102426 is a Phase 3 study of Relapsed/Refractory Multiple Myeloma that has completed, run by PharmaMar. The registered enrollment target is 255 participants, above the 154-participant average among 14 other Relapsed/Refractory Multiple Myeloma trials with a reported enrollment target (66% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01102426, a Phase 3 study of Relapsed/Refractory Multiple Myeloma, has completed, sponsored by PharmaMar.

COMPLETED
Registry status
Phase 3
Development phase
255 participants
Enrollment target
20
Study locations

Study Summary

Study of Plitidepsin in combination with dexamethasone versus dexamethasone alone in patients with relapsed/refractory multiple myeloma.

Primary Outcome

To compare the efficacy of plitidepsin in combination with dexamethasone vs. dexamethasone alone as measured by progression-free survival (PFS) in patients with relapsed/refractory multiple myeloma (MM). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Interventions

  • DRUG Dexamethasone
  • DRUG Plitidepsin

Study Locations (20)

Other

  • 108 - Adelaide
  • 102 - Canberra
  • 101 - Geelong
  • 105 - Parkville
  • 106 - Perth
  • 104 - South Brisbane
  • 109 - Woodville
  • 202 - Graz
  • 204 - Innsbruck
  • 203 - Salzburg
  • 201 - Vienna
  • 205 - Vienna
  • 208 - Vienna
  • 304 - Bruges
  • 301 - Brussels

Alabama

  • 1107 - Tuscaloosa

California

  • 1103 - Los Angeles

Florida

  • 1105 - Jacksonville

New York

  • 1102 - New York

Ohio

  • 1104 - Canton

Trial Details

FieldValue
Enrollment Target 255 participants
Start Date 2010-06
Est. Completion 2017-11
Phase Phase 3
PharmaMar

32 total trials

What the finished NCT01102426 record still lists

NCT01102426 is an interventional study that assigns participants to a tested intervention. The registered 255 participants enrollment target is mid-sized for trials with a published cap, above the 154-participant average among 14 other Relapsed/Refractory Multiple Myeloma trials with a reported enrollment target (66% higher).

The record links to 1 condition, with Relapsed/Refractory Multiple Myeloma appearing as the primary indexed condition, and to 2 interventions - of which Dexamethasone is the first listed.

NCT01102426 names 20 study sites across 6 states, led by Other, Alabama, California.

Frequently Asked Questions

What is clinical trial NCT01102426 about?

NCT01102426 is a clinical study titled "Aplidin - Dexamethasone in Relapsed/Refractory Myeloma". Study of Plitidepsin in combination with dexamethasone versus dexamethasone alone in patients with relapsed/refractory multiple myeloma.

What is the current status of trial NCT01102426?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 255 participants. The study started on 2010-06. Estimated completion is 2017-11.

What conditions does trial NCT01102426 study?

This clinical trial studies the following conditions: Relapsed/Refractory Multiple Myeloma.

What interventions are being tested in trial NCT01102426?

The interventions under investigation include: Dexamethasone (DRUG), Plitidepsin (DRUG).

Who is sponsoring clinical trial NCT01102426?

This trial is sponsored by PharmaMar, which has 32 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01102426 being conducted?

This trial has 20 study locations across Alabama, California, Florida, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Relapsed/Refractory Multiple Myeloma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01102426's enrollment target sits among peer trials

255 4th of 14 higher than 11 of 14 other Relapsed/Refractory Multiple Myeloma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Relapsed/Refractory Multiple Myeloma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01102426, the US trial registry maintained by the National Library of Medicine. NCT01102426 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.