Autologous Stem Cell Transplantation and Maintenance Ther... | NCT01617213

Studies
Autologous Stem Cell Transplantation and Maintenance Therapy for Multiple Myeloma

NCT01617213

Sponsor

University of Virginia

Status

Terminated

Last Update Posted

Jun 21, 2013Estimated

Enrollment

1Actual

Phase

Phase 2

Conditions

Multiple Myeloma

Interventions

Melphalan
Lenalidomide

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

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 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study is no longer needed as recent data have answered the primary hypotheses for this study.

Expanded Access Info

Start Date

Apr 2012

Primary Completion Date

Apr 2015Estimated

Completion Date

Not provided

First Submitted Date

Jun 8, 2012

First Submission Date that Met QC Criteria

Jun 11, 2012

First Posted Date

Jun 12, 2012Estimated

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 20, 2013

Last Update Posted Date

Jun 21, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This trial will determine the feasibility and efficacy of lenalidomide as maintenance therapy in Multiple Myeloma patients treated with dose intensive chemotherapy (Melphalan 200 mg/m2) with autologous PBSC transplant.

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

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Maintenance Lenalidomide After Melphalan	Experimental		Drug: Melphalan Drug: Lenalidomide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Melphalan	Drug	200 mg/m2/IV	Maintenance Lenalidomide After Melphalan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Event Free Survival	Duration of time until patient experiences an event (recurrence, relapse or death)	3 years

Secondary Outcomes

Measure	Description	Time Frame
Disease Response	Number of patients that have complete and very good partial responses.	2 years
Overall survival	Duration of time from Day 0 until death.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Must be 18 to 75 years of age.
ECOG performance status of 0, 1 or 2.
Patients who have a history of another malignant disorder are eligible, provided that they have not received active therapy for 5 years. Patients with basal cell and squamous cell skin cancers are eligible.
Patients who are pregnant are ineligible.
Patients must furnish written informed consent and HIPAA authorization for release of personal health information.
Patients must be able to understand the requirements of the study, abide by the study restrictions, and agree to return for the required assessments.
Patients must be HIV and HTLV-I,-II antibody sero-negative.
Patients must have adequate visceral organ function

Exclusion Criteria:

Patients are ineligible if they have received cumulative chemotherapy doses in excess of: carmustine (BCNU) 400 mg/m2, or a cumulative anthracycline exposure in excess of 550 mg/m2 Adriamycin (doxorubicin) unless the gated-pool radionuclide cardiac scan shows greater than/equal to 45% ejection fraction.
Patients are ineligible if they are receiving any other investigational agents.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Mary J. Laughlin, MD	University of Virginia	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Virginia		Charlottesville	Virginia	22908	United States

Type	Date	Date Unknown
Release	Feb 11, 2016
Reset	Mar 10, 2016

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Feb 11, 2016			Mar 10, 2016

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
D008558	Melphalan
D000077269	Lenalidomide

Ancestor Terms

ID	Term
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds
D006846	Hydrocarbons, Halogenated
D006838	Hydrocarbons

Browse Leaves

Not provided

Browse Branches

Not provided