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Pilot Study Dara-CyBorD in Newly Diagnosed Multiple Myeloma Patients With Renal Failure

ConditionsMultiple MyelomaRenal Failure
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAugusta University

About this trial

The goal of this study is to assess the efficacy of induction treatment with daratumumab-hyaluronidase (dara SC) with cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) for four cycles in patients with newly diagnosed multiple myeloma who have new onset renal failure. This study will also investigate the difference responses in African American (AA) patients versus non-African American patients.

The primary questions this study aims to answer are:

1. To evaluate the very good partial response rate (VGPR) after 4 cycles of Dara-CyBord. 2. To evaluate the renal response rate (RRR) after 4 cycles of Dara-CyBord.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients must have had a confirmed new diagnosis of MM following revised IMWG criteria.

Patients must have Zubrod/ECOG Performance Status ≤ 2.

Patients must have renal insufficiency. Renal insufficiency is defined as eCrCl < 60 mL/min (using Cockcroft-Gault Equation for Cr Cl) and/or necessitating dialysis

must not have known allergies to any of the study drugs. Must have adequate organ function.

Disqualifiers

1. Known seropositive for: human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C.

Trial design

Design model

Single group

Treatments tested in this trial

  • Daratumumab-hyaluronidase in Combination with Bortezomib, Cyclophosphamide, and Dexamethasone

    Combination product

    This intervention is Daratumumab-hyaluronidase in combination with the chemotherapy regimen "CyBord" (cyclophosphamide, bortezomib, and dexamethasone) and then with lenalidomide maintenance in patients with newly diagnosed multiple myeloma who have new onset renal failure.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Dara-CyBorDExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

VGPR

Very good partial response rate (VGPR) or better after 4 cycles of Dara-CyBorD

Time frame
4 months
2

Renal Response Rate (RRR)

Renal response rate (RRR, defined as \> 30% improvement in creatinine clearance - CrCl from baseline at the point of study entry) after 4 cycles of Dara-CyBorD

Time frame
4 months

Secondary outcomes

1

Overall response rate (ORR)

Overall response rate (ORR) after 4 cycles of Dara-CyBorD

Time frame
4 months
2

VGPR, CR, & MRD

Proportion of patients achieving VGPR, CR, and measurable residual disease negativity \<10-5 (MRD-), if applicable, after 4 cycles of Dara-CyBorD

Time frame
4 months
3

Duration of response (DOR)

Duration of response (DOR), defined from the date response achieved to the date of disease relapse

Time frame
2 years
4

Time to renal response

Time to renal response, defined as the number of days from starting treatment to \>30% improvement of CrCl from CrCl at study entry or achieving dialysis independence

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Augusta University

Lead sponsor

Janssen Scientific Affairs, LLC

Collaborator

Source ClinicalTrials.gov
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