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
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
- 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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