"Monoclonal Antibodies for Treatment of Multiple Myeloma. Emphasis on the CD38 Antibody Daratumumab "

NCT02419118 | Completed Phase 2

• 1 other identifier: 181114
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

Daratumumab is a new treatment for patients with myeloma. While many patients benefit from this treatment some do not and the mechanism(s) of failure are poorly understood. This study aims to clarify aspects of resistance to treatment with daratumumab in order to improve patient outcomes in the future.

Conditions

Multiple Myeloma

Keywords

Myeloma; monoclonal antibody; Daratumumab

Outcome Measures

Primary Outcomes (1)

• Response by IMWG criteria

  Assessed by M-component in blood and urine samples

  4 weeks

Secondary Outcomes (1)

• T cell subset numbers

  4 weeks

Study Arms (2)

Dara len dex

EXPERIMENTAL

Daratumumab in combination with lenalidomide and dexamethasone

Drug: Daratumumab; Drug: Lenalidomide; Drug: Dexamethasone

Len dex

ACTIVE COMPARATOR

Lenalidomide in combination with dexamethasone

Drug: Lenalidomide; Drug: Dexamethasone

Interventions

Daratumumab DRUG

Treatment of myeloma patients with Daratumumab

Also known as: CD38 monoclonal antibody, HuMax CD38

Dara len dex

Lenalidomide DRUG

Treatment of myeloma patients

Dara len dex; Len dex

Dexamethasone DRUG

Treatment of myeloma patients

Dara len dex; Len dex

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Accepted for a clinical trial with Daratumumab for myeloma

You may not qualify if:

• None

Sponsors & Collaborators

• Vejle Hospital: lead

Study Sites (1)

Department of Hematology Vejle Hospital

Vejle, 7100, Denmark

Location

Related Publications (2)

• Franssen LE, van de Donk NW, Emmelot ME, Roeven MW, Schaap N, Dolstra H, Hobo W, Lokhorst HM, Mutis T. The impact of circulating suppressor cells in multiple myeloma patients on clinical outcome of DLIs. Bone Marrow Transplant. 2015 Jun;50(6):822-8. doi: 10.1038/bmt.2015.48. Epub 2015 Mar 23.

  PMID: 25798669 RESULT

• Overdijk MB, Verploegen S, Bogels M, van Egmond M, Lammerts van Bueren JJ, Mutis T, Groen RW, Breij E, Martens AC, Bleeker WK, Parren PW. Antibody-mediated phagocytosis contributes to the anti-tumor activity of the therapeutic antibody daratumumab in lymphoma and multiple myeloma. MAbs. 2015;7(2):311-21. doi: 10.1080/19420862.2015.1007813.

  PMID: 25760767 RESULT

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

daratumumab; Lenalidomide; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Torben Plesner, MD

  Vejle Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2015
• First Posted: April 17, 2015
• Study Start: January 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: November 7, 2017

Record last verified: 2017-11

Locations

DK (1)