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Daratumumab, Carfilzomib, Lenalidomide and Low Dose Dexamethasone (DKRd) in Newly Diagnosed, Multiple Myeloma

NCT03500445 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-04-13

No results posted yet for this study

Summary

The purpose of this study is to determine response rate after 8 cycles of D-KRd (daratumumab, carfilzomib, lenalidomide (Revlimid) and dexamethasone in patients with multiple myeloma.

Conditions

Interventions

DRUG

Daratumumab

Daratumumab (16 mg/kg) will be administered as an IV infusion: * Cycle 1-2: 16 mg/kg weekly * Cycles 3-8: 16 mg/kg IV infusion every 2 weeks * Cycles 9-24: 16 mg/kg IV infusion Day 1

DRUG

Carfilzomib

Carfilzomib will be given as an IV infusion over 30 minutes: * 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 allowed at the treating physician's discretion. * Cycle 2-9: 36 mg/m2 (or best tolerated dose) Days 1, 2, 8, 9, 15 and 16 * Cycles 9-24: 36 mg/m2 (or best tolerated dose) Days 1, 2, 15 and 16

DRUG

Lenalidomide

Lenalidomide will be taken orally as follows: • Cycles 1-24: 25 mg (or best tolerated dose) PO Days 1-21

DRUG

Dexamethasone

Dexamethasone will be administered prior to carfilzomib (on days that they coincide), as follows: * Cycles 1-9: 40 mg PO (subjects ≤ 75 years) or 20 mg PO (subjects ≥ 75 years) per week * Cycles 9-24: 20 mg PO per week During weeks when daratumumab is given: 40 mg dexamethasone weekly, 20 mg prior to daratumumab infusion and 20 mg PO the day after During weeks with no daratumumab, single dose of 20 mg on day 1

Sponsors & Collaborators

  • Janssen Scientific Affairs, LLC

    collaborator INDUSTRY

  • Amgen

    collaborator INDUSTRY

  • University of Chicago

    lead OTHER

Principal Investigators

  • Benjamin Derman, MD · University of Chicago

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-13
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
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 NCT03500445 on ClinicalTrials.gov