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DARA RVD For High Risk SMM

NCT04775550 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2025-07-02

No results posted yet for this study

Summary

The purpose of this research study is to learn whether the combination of daratumumab SC ( Darzalex Faspro), lenalidomide (Revlimid), bortezomib (Velcade) and dexamethasone works in treating smoldering multiple myeloma and preventing progression to active or symptomatic multiple myeloma.

The names of the study drugs involved in this study are:

* Daratumumab (also called Darzalex Faspro)
* Bortezomib (also called Velcade)
* Lenalidomide (also called Revlimid)
* Dexamethasone

Conditions

Interventions

DRUG

Daratumumab

Subcutaneous, dosage per protocol, dose days vary per cycle. Cycle =28 days

DRUG

Bortezomib

Subcutaneous, dosage per protocol, dose days vary per cycle. Cycle =28 days

DRUG

Lenalidomide

Oral, dosage per protocol, days 1-21 per cycle

DRUG

Dexamethasone

Oral, dosage per protocol, dose days vary per cycle. Cycle =28 days

Sponsors & Collaborators

  • Janssen Pharmaceuticals

    collaborator INDUSTRY

  • Omar Nadeem, MD

    lead OTHER

Principal Investigators

  • Omar Nadeem, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-08
Primary Completion
2026-12-20
Completion
2030-12-08
FDA Drug
Yes

Countries

  • United States

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 NCT04775550 on ClinicalTrials.gov