NCT02666209

Brief Summary

Participant that has been diagnosed with Relapsed/ Refractory Multiple Myeloma and are currently participating in a clinical trial which is closing. This research study is studying Ulocuplumab as a possible treatment. It's an expanded access from NCT01359657

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 28, 2016

Completed
Last Updated

August 28, 2017

Status Verified

August 1, 2017

First QC Date

January 22, 2016

Last Update Submit

August 25, 2017

Conditions

Multiple Myeloma in RelapseMultiple Myeloma

Keywords

Multiple MyelomaRelapsed Multiple MyelomaRefractory Multiple Myeloma

Interventions

UlocuplumabDRUG

CXCR4 inhibitor given weekly on a 28 day cycle intravenously

Also known as: BMS-936564
LenalidomideDRUG

immunomodulatory agent given days 1-21 of a 28 day cycle orally in subjects not receiving bortezomib

Also known as: Revlimid
BortezomibDRUG

proteasome inhibitor given at physician discretion in subjects not receiving lenalidomide

Also known as: Velcade
DexamethasoneDRUG

steroid given at physician discretion on a 28 day cycles

Also known as: Decadron

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent document
  • Must be currently participating on protocol 11-240 (DFCI)/ CA 212-002(BMS), tolerating therapy, and still receiving benefit from treatment.

You may not qualify if:

  • Prior exposure to Ulocuplumab other than in DFCI Protocol 11-240 (BMS protocol CA212-002) or any other any other CXCR4 inhibitor (small molecule within 14 days; antibody against CXCR4 within 10 weeks).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

ulocuplumabLenalidomideBortezomibDexamethasoneCalcium Dobesilate

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingBoronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsPyrazinesPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedBenzenesulfonatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Irene M Ghobrial, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
expanded access
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Irene M. Ghobrial, MD

Study Record Dates

First Submitted

January 22, 2016

First Posted

January 28, 2016

Last Updated

August 28, 2017

Record last verified: 2017-08

Locations

US(1)