A Study to Analyze the Occurrence of Transformation From Myelodysplastic Syndrome to Acute Myeloid Leukemia in Patients With Myelodysplastic Syndrome Who Received Revlimid® 5 mg Capsules and Who Are Continuing or no Longer Continuing Revlimid Treatment

NCT02921815 | Completed

• 1 other identifier: NIS-Celgene-JP-PMS-001c
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

To analyze the occurrence of transformation from myelodysplastic syndrome (MDS) to acute myeloid leukemia (hereinafter referred to as transformation from MDS to AML) in patients with myelodysplastic syndrome with a deletion 5q cytogenetic abnormality (hereinafter referred to as del(5q)MDS) who received Revlimid® 5 mg Capsules (hereinafter referred to as Revlimid) and who are continuing or no longer continuing Revlimid treatment.

1. 1.Planned registration period This period started on the date of initial marketing of Revlimid and will end on the day when the appropriateness of enrollment is assessed for all del(5qMDS) patients in the all-case surveillance.
2. 2.Planned surveillance period This period started on the date of initial marketing of Revlimid and will end 3 years after the last enrolled patient begins receiving Revlimid.

Conditions

Myelodysplastic Syndromes; Leukemia, Myeloid, Acute

Keywords

Leukemia; Acute Myeloid Leukemia; Revlimid

Outcome Measures

Primary Outcomes (1)

• Adverse Events (AEs)

  Number of participants with adverse events

  3 years

Study Arms (1)

Patients with myeloid leukemia

All del(5q) Myelodysplastic syndrome (MDS) patients in the all-case surveillance in whom transformation to acute myeloid leukemia has not been documented at the end of the observation period of the all-case surveillance.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All del(5q) Myelodysplastic syndrome (MDS) patients in the all-case surveillance in whom transformation to acute myeloid leukemia (hereinafter referred to as Acute Myelogenous Leukemia (AML)) has not been documented at the end of the observation period of the all-case surveillance.

You may qualify if:

• All del(5q)MDS patients in the all-case surveillance in whom transformation to acute myeloid leukemia (hereinafter referred to as AML) has not been documented at the end of the observation period of the all-case surveillance.

You may not qualify if:

• N/A

Sponsors & Collaborators

• Celgene: lead

Study Sites (1)

Shinko Hospital

Kobe, Hyōgo, 651-0072, Japan

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes; Leukemia, Myeloid, Acute; Leukemia

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2016
• First Posted: October 3, 2016
• Study Start: March 3, 2011
• Primary Completion: August 31, 2014
• Study Completion: August 31, 2014
• Last Updated: June 14, 2022

Record last verified: 2022-06

Locations

JP (1)