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Combination of Lenalidomide and Dexamethasone in Treatment of Multiple Myeloma

NCT01090089 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 348

Last updated 2023-02-23

No results posted yet for this study

Summary

In this study for elderly myeloma patients lenalidomide plus low-dose dexamethasone until progression is being compared with age-adjusted tandem high-dose melphalan 140 mg/m² augmented by induction with 3 cycles of lenalidomide plus low-dose dexamethasone before transplantation and lenalidomide maintenance after transplantation.

Conditions

Interventions

DRUG

Lenalidomide, Dexamethasone

Rd until progression or max. 5 years (Rd = lenalidomide 25 mg d1-21/28d + dexamethasone 40 mg po d1, d8, d15, d22/28d)

DRUG

Lenalidomide, Dexamethasone, PBSCT

Induction with 3 cycles Rd, tandem high dose melphalan (140 mg/m²) with autologous peripheral blood stem cell transplantation (PBSCT) followed by lenalidomide maintenance (10 mg/day) until progression or max. 5 years

Sponsors & Collaborators

  • ClinAssess GmbH

    collaborator INDUSTRY

  • Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH

    lead OTHER

Principal Investigators

  • Christian Straka · Agirov Klinik

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-01
Primary Completion
2020-01-31
Completion
2020-01-31

Countries

  • Germany

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 NCT01090089 on ClinicalTrials.gov