NCT01178814

Revlimid in Transfusion Dependent Patients

Completed Phase 2 Results posted Last updated 24 June 2024

What this trial tests

Phase 2 trial testing Revlimid (Lenalidomide) in Myelodysplastic Syndrome in 57 participants. Completed in 7 December 2022.

Timeline

1 June 2009

Primary endpoint
1 September 2022

7 December 2022

Quick facts

Lead sponsor	Columbia University
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	57
Start date	1 June 2009
Primary completion	1 September 2022
Estimated completion	7 December 2022
Sites	1 location across United States

Drugs / interventions tested

• Revlimid (Lenalidomide) — full drug profile →

Conditions studied

• Myelodysplastic Syndrome — all drugs for Myelodysplastic Syndrome →

Sponsor

Columbia University

Who can join

21 and older, any sex, with Myelodysplastic Syndrome. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Response Signature in Transfusion Dependent MDS Patients Primary · Up to 12 weeks from baseline

The trial will be testing the Revlimid® (lenalidomide) response signature in patients who have transfusion dependent, non-del(5q), low and intermediate-1 risk myelodysplastic syndromes (MDS) in order to confirm the predictive value of the signature and to establish the boundaries of the z-score which can be used to pre-select patients in future clinical studies. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longe

Group	Value	95% CI
Revlimid	24
Revlimid	1
Revlimid	17
Revlimid	6

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 3 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Revlimid

Serious: 3/57 (5%)

Deaths: 0/57

Serious adverse events (3 terms)

Reaction	System	Revlimid
Diarrhea	Gastrointestinal disorders	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—
Febrile neutropenia	Blood and lymphatic system disorders	—

Other adverse events (4 terms — click to expand)

Reaction	System	Revlimid
Diarrhea	Gastrointestinal disorders	—
Platelet count abnormality	Investigations	—
Rash	Skin and subcutaneous tissue disorders	—
Back Pain	Musculoskeletal and connective tissue disorders	—

Most-reported serious reactions: Diarrhea, Dyspnea, Febrile neutropenia.

Data from ClinicalTrials.gov NCT01178814 adverse events section.

Sponsor's own description

This is a prospective trial of Revlimid for subjects who have a blood cell cancer called myelodysplastic syndrome (MDS). Cells in their marrow make proteins through messages that are carried from the genes. The amount of the message tells researchers if the protein it is going to make is high or low. This is known as expression of genes. The purpose of this study is to conduct a prospective trial testing the idea that expression of specific genes can help to predict which patients will respond to study drug administration with Revlimid (lenalidomide).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.