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Phase II Study of Biaxin, Revlimid, and Dexamethasone for Untreated Multiple Myeloma

NCT00151203 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-05-27

No results posted yet for this study

Summary

PRIMARY STUDY OBJECTIVES

* To evaluate the efficacy of the combination of clarithromycin (Biaxin®), lenalidomide (Revlimid™), and dexamethasone (Decadron®) as an induction therapy for patients with newly diagnosed multiple myeloma (MM).
* To evaluate the safety of the combination of clarithromycin, lenalidomide, and dexamethasone as an induction therapy for patients with newly diagnosed MM.

SECONDARY STUDY OBJECTIVES

* To examine the role of clarithromycin on the pharmacokinetic properties of dexamethasone and lenalidomide.
* To examine the angiogenesis profile in untreated patients and in patients receiving induction therapy.

Conditions

Interventions

DRUG

Clarithromycin, Lenalidomide, Dexamethasone

Dexamethasone (Decadron®) will be given orally at a dose of 40 mg on days 1, 2, 3, 8, 15 and 22 during the first cycle and once a week on days 1, 8, 15, and 22 for each subsequent cycle. Clarithromycin (Biaxin®) will be given orally at a dose of 500 mg twice a day beginning on day 2 of cycle 1. Lenalidomide (Revlimid®) will be given orally at a dose of 25 mg daily beginning on day 3 and ending on day 21 of cycle 1 and on days 1-21 of subsequent cycles.

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Ruben Niesvizky, MD · Weill Medical College of Cornell University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2007-04-30
Completion
2020-09-29
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00151203 on ClinicalTrials.gov