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

NCT ID: NCT02419118

Last Updated: 2017-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-10-01

Brief Summary

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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.

Detailed Description

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The effector mechanisms of daratumumab have been extensively studied in vitro, but the in vivo correlates and key determinants of success or failure when daratumumab is used alone or in combination with lenalidomide for treatment of patients with myeloma have not been clarified.

There is potentially a wide spectrum of factors that may influence the quality and duration of response following treatment with daratumumab. The integrity of the patient's immune system may be important. Prior lines of chemotherapy or the myeloma disease itself may impair humural (i.e. complement) or cellular (i.e. ADCC) effector mechanisms that are of importance for the response to daratumumab. Also intrinsic properties of the tumor cells or interactions between myeloma cells and the bone marrow microenvironment could make the myeloma cells refractory to daratumumab.

A better understanding of these variables may enable us to improve the quality and duration of daratumumab-induced responses and make daratumumab-based therapies more effective in the near future.

Conditions

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Multiple Myeloma

Keywords

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Myeloma monoclonal antibody Daratumumab

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dara len dex

Daratumumab in combination with lenalidomide and dexamethasone

Group Type EXPERIMENTAL

Daratumumab

Intervention Type DRUG

Treatment of myeloma patients with Daratumumab

Lenalidomide

Intervention Type DRUG

Treatment of myeloma patients

Dexamethasone

Intervention Type DRUG

Treatment of myeloma patients

Len dex

Lenalidomide in combination with dexamethasone

Group Type ACTIVE_COMPARATOR

Lenalidomide

Intervention Type DRUG

Treatment of myeloma patients

Dexamethasone

Intervention Type DRUG

Treatment of myeloma patients

Interventions

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Daratumumab

Treatment of myeloma patients with Daratumumab

Intervention Type DRUG

Lenalidomide

Treatment of myeloma patients

Intervention Type DRUG

Dexamethasone

Treatment of myeloma patients

Intervention Type DRUG

Other Intervention Names

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CD38 monoclonal antibody HuMax CD38

Eligibility Criteria

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Inclusion Criteria

* Accepted for a clinical trial with Daratumumab for myeloma

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vejle Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Torben Plesner, MD

Role: PRINCIPAL_INVESTIGATOR

Vejle Hospital

Locations

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Department of Hematology Vejle Hospital

Vejle, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type RESULT
PMID: 25798669 (View on PubMed)

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.

Reference Type RESULT
PMID: 25760767 (View on PubMed)

Other Identifiers

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181114

Identifier Type: -

Identifier Source: org_study_id