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Trial of Carfilzomib, Lenalidomide, Dexamethasone Versus Lenalidomide Alone After Stem-cell Transplant for Multiple Myeloma

NCT02659293 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-03-04

No results posted yet for this study

Summary

This is a Phase 3 randomized trial of carfilzomib, lenalidomide, dexamethasone versus lenalidomide alone after stem-cell transplant for multiple myeloma, eligible to subjects who completed autologous stem cell transplant for symptomatic myeloma who are considered for lenalidomide maintenance.

Conditions

Interventions

DRUG

Lenalidomide

* Cycle 1: 15 mg days 1-21 * Cycles 2-4: 25 mg days 1-21 if tolerated, otherwise continue at lower dose * Cycles 5 and beyond: best tolerated dose days 1-21

DRUG

Carfilzomib

* Cycle 1: 20 mg/m2 Days 1, 2; 36 mg/m2 Days 8, 9, 15, 16. Alternatively, intermediate dose escalation (to 27mg/m2 on days 8,9 of cycle 1) will be al12,lowed at the treating physician's discretion. * Cycle 2-4: 36 mg/m2 if tolerated Days 1, 2, 8, 9, 15, 16 * Cycles 5-8 (patients that are MRD- and have no risk factors at the end of cycle 6) and Cycle 5 - 36 (for MRD+ patients and high risk patients at the end of cycle 6): best tolerated dose Days 1, 2, 15, 16

DRUG

Dexamethasone

* Cycles 1 - 4: 20 mg PO or IV per dose Days 1, 8, 15, 22 * Cycles 5+: 20 mg or best tolerated dose PO or IV per dose Days 1, 8, 15, 22

DRUG

Lenalidomide (Control)

* Cycles 1-4: Days 1-28. Lenalidomide will begin at a dose of 10 mg PO daily (2 capsules per day). After three months, the dose will be increased, provided ANC ≥ 1,000/µL, platelet count ≥ 75,000/µL, and all nonhematologic toxicity is ≤ grade 1, to 15 mg PO daily (3 capsules per day). * Cycles 5 and beyond: best tolerated dose days 1-28

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Principal Investigators

  • Andrzej Jakubowiak, MD, PhD · University of Chicago

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-26
Primary Completion
2027-11-30
Completion
2027-11-30

Countries

  • United States
  • Poland

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 NCT02659293 on ClinicalTrials.gov