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Low-Dose Azacitidine, Lenalidomide, and Low-Dose Dexamethasone in Relapsed or Refractory Multiple Myeloma

NCT01155583 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2020-11-16

Study results available
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Summary

RATIONALE: Drugs used in chemotherapy, such as azacitidine and dexamethasone, work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Giving azacitidine together with lenalidomide and dexamethasone may kill more cancer cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of azacitidine when given together with lenalidomide and low-dose dexamethasone in treating patients with relapsed or refractory multiple myeloma.

Conditions

  • Refractory Multiple Myeloma

Interventions

DRUG

azacitidine

Given by subcutaneous injection (SC)

DRUG

lenalidomide

Given orally

DRUG

dexamethasone

Given orally

OTHER

DNA methylation analysis

Correlative studies

OTHER

gene expression analysis

Correlative studies

OTHER

bone marrow aspiration

Correlative studies

OTHER

immunohistochemistry staining method

Correlative studies

OTHER

reverse transcriptase-polymerase chain reaction

Correlative studies

OTHER

flow cytometry

Correlative studies

Sponsors & Collaborators

  • Case Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Frederic Reu · Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

  • Ehsan Malek, MD · University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2016-05-28
Completion
2018-11-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01155583 on ClinicalTrials.gov