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Isa-RVD Study in Patients With Newly Diagnosed Multiple Myeloma

NCT05123131 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2025-07-08

No results posted yet for this study

Summary

This study aims to evaluate the stringent Complete Response (sCR) rate by the end of two cycles of induction treatment, defined as the proportion of patients who have achieved sCR, according to International Myeloma Working Group (IMWG) criteria, by the end of two cycles of induction treatment.

Conditions

Interventions

DRUG

Isatuximab

Isatuximab (IV): 10 mg/kg on Days 1, 8, 15, 22, 29 in Cycle 1; from Cycle 2 onwards, it will be given on Days 1, 15, 29.

DRUG

Bortezomib

Bortezomib (SQ): 1.3 mg/m² on Days 1, 4, 8, 11, 22, 25, 29, and 32.

DRUG

Lenalidomide

Lenalidomide (PO): 25 mg/day (10 mg/day for patients with creatinine clearance \[CrCl\] ≥30 to \<60 mL/min) from Day 1 to Day 14 and from Day 22 to Day 35 of each cycle.

DRUG

Dexamethasone (IV)

Dexamethasone (IV on the days of Isatuximab and PO on other days): 20 mg/day on Days 1, 2, 4, 5, 8, 9, 11, 12, 15, 16, 22, 23, 25, 26, 29, 30, 32, and 33. If patients are ≥75 years old, dexamethasone will be administered on Days 1, 4, 8, 11, 15, 16, 22, 25, 29 and 32.

Sponsors & Collaborators

Principal Investigators

  • Prof Peter O'Gorman · Mater Misericordiae University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2025-06-24
Completion
2027-12-15

Countries

  • Denmark
  • Ireland

Study Locations

More Related Trials

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 NCT05123131 on ClinicalTrials.gov