Revlimid in Transfusion Dependent Patients

NCT01178814 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: AAAF2696
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Myelodysplastic Syndrome

Outcome Measures

Primary Outcomes (1)

• Response Signature in Transfusion Dependent MDS Patients

  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 longest diameter of target lesions.

  Up to 12 weeks from baseline

Study Arms (1)

Revlimid

EXPERIMENTAL

Revlimid (Lenalidomide) capsule taken orally once a day

Drug: Revlimid (Lenalidomide)

Interventions

Revlimid (Lenalidomide) DRUG

The starting dose will be 10 mg days 1-28 with the first dose reduction going to 5 mg days 1-28 of a 28 day cycle. Therapy will cease if there is no response after 12 weeks.

Also known as: Revlimid

Revlimid

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Understand and voluntarily sign an informed consent form.
• Age ≥ 21 years at the time of signing the informed consent form.
• Able to adhere to the study visit schedule and other protocol requirements.
• A confirmed diagnosis (using standard FAB criteria) of a myelodysplastic syndrome with low/Int-1 risk and with a non-del(5q) karyotype must be established.
• Patients must have transfusion dependence (at least 2 units within 8 weeks prior to starting therapy).
• All transfusion dependent non-del(5q) low/Int-1 risk patients will be eligible for treatment with Revlimid®
• Newly diagnosed as well as previously treated patients will be eligible
• Patients with primary de novo or secondary MDS will be eligible
• All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study.
• ECOG performance status of 0-2 at study entry (see Appendix II).
• Laboratory test results within these ranges:
• Absolute neutrophil count \> 250/uL
• Platelet count \> 30,000/uL
• Serum creatinine ≤ 2.0 mg/dL
• Total bilirubin ≤ 1.5 mg/dL

You may not qualify if:

• Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
• Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
• Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
• Any clinically significant cardiac disease, including congestive heart failure
• Liver function studies including SGOT/SGPT \> 3 x ULN
• Clinically significant renal disease.
• Any previous chemotherapy, hematopoietic growth factors, erythropoietin, or cytokines within 4 weeks of starting treatment. Note: prior therapy with G-CSF within 4 weeks is allowed.
• Use of any other experimental drug or therapy within 28 days of baseline.
• Known hypersensitivity to thalidomide.
• The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
• Any prior use of lenalidomide. (Patients with prior therapy with thalidomide will be eligible as long as at least 4 weeks have elapsed between end of the drug and accrual on the present trial)
• Concurrent use of other anti-cancer agents or treatments.
• Known positive for HIV or infectious hepatitis, type B or C.
• Life expectancy \< 3 months

Sponsors & Collaborators

• Columbia University: lead
• Celgene Corporation: collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Mark Heaney, MD
• Organization: Columbia University Irving Medical Center

mlh2192@cumc.columbia.edu

646-317-5199

Study Officials

• Mark Heaney, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2010
• First Posted: August 10, 2010
• Study Start: June 1, 2009
• Primary Completion: September 1, 2022
• Study Completion: December 7, 2022
• Last Updated: June 24, 2024
• Results First Posted: July 20, 2021

Record last verified: 2024-06

Locations

US (1)