Monoclonal Antibody-Based Sequential Therapy for Deep Remission in Multiple Myeloma

NCT03224507 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2023-11-24

Study results available
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Summary

Multiple myeloma (MM), a plasma cell disorder, is the second most common hematologic malignancy in the U.S. No standard curative therapy has yet been found. A variety of therapeutic measures including high dose melphalan, induction therapy, and continuous therapy have been used but the goal of complete response without relapse has not been achieved. More active treatment regimens and better tools for response assessment are needed.

Conditions

Interventions

DRUG

KRdD followed by auto-HCT

Dosages of each drug will vary depending on therapy type and cycle number. KRdD therapy will be followed by autologous hematopoietic cell transplantation and KRdD consolidation.

DRUG

KRdD only

Dosages of each drug will vary depending on therapy type and cycle number. KRdD therapy will not be followed by autologous hematopoietic cell transplantation but will proceed with KRdD consolidation.

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY
  • Janssen Scientific Affairs, LLC

    collaborator INDUSTRY
  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Luciano J Costa, MD, PhD · University of Alabama at Birmingham

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-14
Primary Completion
2023-05-01
Completion
2023-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

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 NCT03224507 on ClinicalTrials.gov