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Carfilzomib, Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone in High- Risk SMM

NCT03673826 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2023-11-01

No results posted yet for this study

Summary

Randomized (2:1) multi-center open-label phase II trial. Patients with high-risk SMM will be enrolled on the study and treated with KRd combination (Cycles 1-9 carfilzomib 20/36 mg/m2, lenalidomide 25 mg, dexamethasone 20 mg cycles 1-4 and 10 mg cycles 5-9) or Rd combination (Cycles 1-9 lenalidomide 25 mg, dexamethasone 20 mg cycles 1-4 and 10 mg cycles 5-9); followed by extended lenalidomide dosing (10 mg days 1-21 of a 28 day cycle for 24 cycles).

Conditions

  • Smouldering Myeloma

Interventions

DRUG

Carfilzomib

9 cycles 20/36mg/m2 days 1,2,8,9,15,16

DRUG

Dexamethasone

4 cycles 20 mg days 1,2,8,9,15,16,22,23 followed by 5 cycles 10mg days 1,2,8,9,15,16,22,23

DRUG

Lenalidomide

9 cycles 25mg days 1-21 followed by 24 extended dosing cycles 10mg days 1-21

Sponsors & Collaborators

  • Stichting Hemato-Oncologie voor Volwassenen Nederland

    lead OTHER

Principal Investigators

  • A. Broijl · Erasmus MC / HOVON

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-19
Primary Completion
2024-08-31
Completion
2028-12-31

Countries

  • Czechia
  • Italy
  • Netherlands
  • Norway

Study Locations

More Related Trials

Entities

Drugs

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 NCT03673826 on ClinicalTrials.gov