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Study of Single Agent Lenalidomide in Older Adults With Newly Diagnosed Multiple Myeloma

NCT01054144 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2021-10-13

Study results available
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Summary

The purpose of this research is to estimate the effectiveness of a response adapted approach with the use of the drug, lenalidomide in the treatment of older adults with newly diagnosed standard risk multiple myeloma. This means that participants will be given the study drug, lenalidomide but depending on how they respond to this drug they may also be given dexamethasone and/or prednisone to help with their treatment.

Conditions

Interventions

DRUG

Lenalidomide

* Starting Dose: 25 mg by mouth (PO) days 1-21 of a 28 days cycle; * Dose Level -1: 15 mg PO days 1-21 of a 28 days cycle; * Dose Level -2: 10 mg PO days 1-21 of a 28 days cycle; * Dose Level -3: 5 mg PO days 1-21 of a 28 days cycle; * Dose Level -4: Discontinue

DRUG

Prednisone

* Starting Dose: 100 mg PO days 1-5 every 28 days; * Dose level -1: 50 mg PO days 1-5 of a 28 day cycle; * Dose level -2: 25 mg PO days 1-5 of a 28 day cycle; * Dose level -3: Discontinue

DRUG

Dexamethasone

* Starting Dose: 40 mg daily on days 1 - 4 every 28 days; * Dose level -1: 20 mg daily on days 1 - 4 every 28 days; * Dose level -1a: 40 mg daily on days 1, 2, and 3 followed by 20 mg on day 4 followed by 12 mg on day 5 followed by 8 mg on day 6; * Dose level -2: 10 mg daily on days 1 - 4 every 28 days; * Dose level -3: Discontinue

Sponsors & Collaborators

  • Celgene

    collaborator INDUSTRY

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Rachid Baz, M.D. · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-14
Primary Completion
2020-08-31
Completion
2020-11-24

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT01054144 on ClinicalTrials.gov