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NCT00847639 · ClinicalTrials.gov registry record · Phase 2

Safety Study of Lenalidomide Maintenance Therapy Post Allogeneic HCT for High-risk Multiple Myeloma

A Phase 2 study, sponsored by Center for International Blood and Marrow Transplant Research.

Completed
Registry status
Phase 2
Development phase
30
Enrollment target

NCT00847639 is a Phase 2 study that has completed, run by Center for International Blood and Marrow Transplant Research. The registered enrollment target is 30 participants.

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The verdict

NCT00847639, a Phase 2 study, has completed, sponsored by Center for International Blood and Marrow Transplant Research.

COMPLETED
Registry status
Phase 2
Development phase
30 participants
Enrollment target

Study Summary

This is a multi-institution, non-randomized, open label, Phase IIa prospective trial to evaluate the safety and tolerability of maintenance lenalidomide after allogeneic hematopoietic stem cell transplantation (HCT). Lenalidomide maintenance therapy will start between day 60 and 90 after allogeneic HCT at a starting dose of 10mg PO once daily. Dose escalation and de-escalation will be performed depending on tolerability of lenalidomide. Dose range is 5mg every other day to 5 - 25 mg given daily on days 1-21 of a 28-day cycle for 12 cycles maximum or maximum of 12 months from first dose of study drug. Patients will be followed until 28 days from completing the 12th planned cycle of lenalidomide maintenance or 12 months from first dose of study drug, which ever comes first, (14 to 15 months after receiving the allograft) or discontinuation of study drug.

Interventions

  • DRUG lenalidomide

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2009-02
Est. Completion 2014-03
Phase Phase 2

What the Registry Record Tells You About NCT00847639

The ClinicalTrials.gov registry entry for NCT00847639 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Center for International Blood and Marrow Transplant Research, which has 29 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which lenalidomide is the first listed.

NCT00847639 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00847639 about?

NCT00847639 is a clinical study titled "Safety Study of Lenalidomide Maintenance Therapy Post Allogeneic HCT for High-risk Multiple Myeloma". This is a multi-institution, non-randomized, open label, Phase IIa prospective trial to evaluate the safety and tolerability of maintenance lenalidomide after allogeneic hematopoietic stem cell transplantation (HCT). Lenalidomide maintenance therapy will start between day 60 and 90 after allogeneic...

What is the current status of trial NCT00847639?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2009-02. Estimated completion is 2014-03.

What interventions are being tested in trial NCT00847639?

The interventions under investigation include: lenalidomide (DRUG).

Who is sponsoring clinical trial NCT00847639?

This trial is sponsored by Center for International Blood and Marrow Transplant Research, which has 29 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.