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Melphalan, Prednisone, and Lenalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma

NCT00477750 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2019-10-11

Study results available
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Summary

RATIONALE: Drugs used in chemotherapy, such as melphalan, prednisone, and lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of melphalan and lenalidomide when given together with prednisone and to see how well they work in treating patients with newly diagnosed multiple myeloma.

Conditions

  • Multiple Myeloma and Plasma Cell Neoplasm

Interventions

DRUG

lenalidomide

Phase I - dose escalating: 5mg level -1, 10mg level 0, 10mg level 1, 15mg level 2, 20mg level 3, 25mg level 4, orally days 1-21 every 28 days until progression Phase II - 10 mg orally days 1-21 every 28 days until progression

DRUG

melphalan

Phase I - dose escalating: 5mg/m\^2 dose level -1, 5 mg/m\^2 dose level 0, 8 mg/m\^2 dose level 1 - 4, daily x 4 orally days every 28 days until progression Phase II - 5mg/m\^2 orally days 1-4 every 28 days until progression

DRUG

prednisone

60mg/m\^2, orally days 1-4 every 28 days until progression

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Vivek Roy, MD, FACP · Mayo Clinic

  • Philip R. Greipp, MD · Mayo Clinic

  • Craig B. Reeder, MD · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2008-04-30
Completion
2013-08-05

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

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 NCT00477750 on ClinicalTrials.gov