A Study of Motexafin Gadolinium for the Treatment of Rela... | NCT00096837

Studies
A Study of Motexafin Gadolinium for the Treatment of Relapsed or Refractory Multiple Myeloma

NCT00096837

Sponsor

Pharmacyclics LLC.

Status

Completed

Last Update Posted

Jun 8, 2006Estimated

Enrollment

Phase

Phase 2

Conditions

Multiple Myeloma

Interventions

Motexafin Gadolinium Injection

Countries

United States

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

Jun 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Nov 16, 2004

First Submission Date that Met QC Criteria

Nov 16, 2004

First Posted Date

Nov 17, 2004Estimated

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

Jun 7, 2006

Last Update Posted Date

Jun 8, 2006Estimated

Description Module

Brief Summary

The purpose of the study is to determine if the drug motexafin gadolinium will be an effective treatment for patients who have relapsed or refractory multiple myeloma.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Motexafin Gadolinium Injection	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of complete response, partial response and stable disease (clinical benefit rate)

Secondary Outcomes

Measure	Description	Time Frame
Progression-free survival
Safety and tolerability

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Relapsed or Refractory Multiple Myeloma
≥ 18 years old
Able to provide consent for participation
ECOG status 0-2

Lab values:

ANC ≥ 1,000/µL
WBC count ≥ 2.0/µL
Hemoglobin ≥ 8.0 g/dL
Platelet count ≥ 50,000/µL
AST and ALT ≤ 2 x ULN
Total Bilirubin ≤ 2 x ULN
Creatinine ≤ 2.0 mg/dL

and

Not pregnant or lactating

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Robert H. Lurie Comprehensive Cancer Center		Chicago	Illinois	60611	United States

Condition Browse Module

MeSH Terms

ID	Term
D009101	Multiple Myeloma
D054219	Neoplasms, Plasma Cell

Ancestor Terms

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020141	Hemostatic Disorders
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided