Safety, Efficacy, Dose-finding Study of a Monoclonal Anti... | NCT00231166

Studies
Safety, Efficacy, Dose-finding Study of a Monoclonal Antibody in Patients With Multiple Myeloma

NCT00231166

Sponsor

Novartis Pharmaceuticals

Status

Completed

Last Update Posted

Oct 11, 2018Actual

Enrollment

33Actual

Phase

Phase 1

Conditions

Multiple Myeloma

Interventions

HCD122

Countries

United States
Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

May 2009Actual

Completion Date

May 2009Actual

First Submitted Date

Sep 30, 2005

First Submission Date that Met QC Criteria

Sep 30, 2005

First Posted Date

Oct 4, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 9, 2018

Last Update Posted Date

Oct 11, 2018Actual

Description Module

Brief Summary

The purpose of this study is to determine the highest tolerated dose, safety and activity of HCD122 in patients with Multiple Myeloma who are relapsed after receiving prior treatment.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

33Actual

Label	Type	Description	Intervention Names
HCD122	Experimental		Drug: HCD122

Name	Type	Description	Arm Group Labels	Other Names
HCD122	Drug		HCD122

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety, pharmacokinetics and pharmacodynamics at multiple doses		At the completion of each dose escalation cohort

Secondary Outcomes

Measure	Description	Time Frame
Clinical response after various doses		Once a month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical Diagnosis of MM requiring treatment
Refractory or Relapsed Disease
At least one prior treatment regimen
Male or Female
>18 years of age

Exclusion Criteria:

Prior Allogeneic bone marrow transplant (prior autologous transplant allowed)
Intracranial disease or epidural disease
Clinically significant cardiac dysfunction or other significant organ dysfunction

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director
Novartis Pharmaceuticals	Novartis Pharmeceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dana Farber Cancer Institute StudyCoordinator:CHCD122A2102		Boston	Massachusetts	02115	United States

Condition Browse Module

MeSH Terms

ID	Term
D009101	Multiple Myeloma

Ancestor Terms

ID	Term
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020141	Hemostatic Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C578314	lucatumumab

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided