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NCT01745588 · ClinicalTrials.gov registry record · Phase 2

Autologous Stem Cell Transplant With Pomalidomide (CC-4047®) Maintenance Versus Continuous Clarithromycin/ Pomalidomide / Dexamethasone Salvage Therapy in Relapsed or Refractory Multiple Myeloma

A Phase 2 study, sponsored by Memorial Sloan Kettering Cancer Center.

Completed
Registry status
Phase 2
Development phase
23
Enrollment target

NCT01745588: Completed Phase 2 study, sponsored by Memorial Sloan Kettering Cancer Center.

NCT01745588 is a Phase 2 study that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 23 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01745588, a Phase 2 study, has completed, sponsored by Memorial Sloan Kettering Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
23 participants
Enrollment target

Study Summary

The purpose of this study is to see whether pomalidomide (also known as Pomalyst) reduces the number of myeloma cells in the bones, and to see what is the best way to use pomalidomide in patients with myeloma. To do this, the investigators want to compare two types of treatment using pomalidomde. This is a randomized trial which means that the decision as to which treatment the patient will receive will be made by a computer, much like flipping a coin. All patients start by receiving 4 cycles of clarithromycin, pomalidomide and dexamethasone (ClaPD). After 4 cycles, half of the patients will undergo an autologous stem cell transplant followed by pomalidomide (Group 1). The other half of the patients will continue to receive ClaPD for 9 cycles to be followed by pomalidomide maintenance. (Group 2). At the end of the study, the two groups will be compared to see if there is a difference in disease outcome.

Primary Outcome

Very Good PR or greater will be evaluated nine months postrandomization according to International Uniform Response Criteria.

Interventions

  • DRUG Dexamethasone
  • DRUG Pomalidomide
  • DRUG Clarithromycin
  • PROCEDURE stem cell

Trial Details

FieldValue
Enrollment Target 23 participants
Start Date 2012-12
Est. Completion 2025-09-03
Phase Phase 2
Memorial Sloan Kettering Cancer Center

1,884 total trials

What the finished NCT01745588 record still lists

NCT01745588 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).

The record links to 0 conditions, and to 4 interventions - of which Dexamethasone is the first listed.

NCT01745588 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01745588 about?

NCT01745588 is a clinical study titled "Autologous Stem Cell Transplant With Pomalidomide (CC-4047®) Maintenance Versus Continuous Clarithromycin/ Pomalidomide / Dexamethasone Salvage Therapy in Relapsed or Refractory Multiple Myeloma". The purpose of this study is to see whether pomalidomide (also known as Pomalyst) reduces the number of myeloma cells in the bones, and to see what is the best way to use pomalidomide in patients with myeloma. To do this, the investigators want to compare two types of treatment using pomalidomde. Th...

What is the current status of trial NCT01745588?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2012-12. Estimated completion is 2025-09-03.

What interventions are being tested in trial NCT01745588?

The interventions under investigation include: Dexamethasone (DRUG), Pomalidomide (DRUG), Clarithromycin (DRUG), stem cell (PROCEDURE).

Who is sponsoring clinical trial NCT01745588?

This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01745588's enrollment target sits among peer trials

23 1784th of 2000 higher than 211 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT01745588, the US trial registry maintained by the National Library of Medicine. NCT01745588 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.