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Aggressive Smoldering Curative Approach Evaluating Novel Therapies and Transplant

NCT03289299 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2023-12-12

No results posted yet for this study

Summary

This study evaluates the use of carfilzomib, lenalidomide, daratumumab, and dexamethasone in subjects with high-risk smoldering multiple myeloma (SMM). Subjects will receive treatment in 3 phases - induction (6 cycles), consolidation (6 cycles), and maintenance (12 cycles). Each cycle is 28 days.

Conditions

  • Smoldering Multiple Myeloma

Interventions

DRUG

Carfilzomib

56 mg/m2 IV given on days 1, 8, and 15 of each cycle during induction and consolidation phases of the study.

DRUG

Lenalidomide

25 mg po given on days 1-21 of each cycle during the induction and consolidation phases. 10 mg po given on days 1-21 of each cycle during the maintenance phase.

DRUG

Daratumumab

16 mg/kg IV given on days 1, 8, 15, and 22 of cycles 1-2; days 1 and 15 of cycles 3-6; day 1 of cycle 7-12; Day 1 of odd cycles for cycles 13-24.

DRUG

Dexamethasone

40 mg oral given on days 1, 8, 15, and 22 of cycles 1-6 20 mg oral given on days 1, 8, 15, and 22 of cycles 7-12

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • Janssen Scientific Affairs, LLC

    collaborator INDUSTRY

  • Celgene

    collaborator INDUSTRY

  • Trevie, Inc.

    collaborator UNKNOWN

  • International Myeloma Foundation

    lead OTHER

Principal Investigators

  • Shaji Kumar, MD · Mayo Clinic

  • Brian Durie, MD · International Myeloma Foundation

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-25
Primary Completion
2023-09-26
Completion
2031-11-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT03289299 on ClinicalTrials.gov