Total Marrow Irradiation & Autologous Stem Cell Transplan... | NCT00800059

Studies
Total Marrow Irradiation & Autologous Stem Cell Transplantation for Relapsed or Refractory Myeloma

NCT00800059

Sponsor

Ottawa Hospital Research Institute

Status

Unknown status

Last Update Posted

Jul 27, 2015Estimated

Enrollment

27Estimated

Phase

Phase 1Phase 2

Conditions

Multiple Myeloma

Interventions

Total Marrow Irradiation

Countries

Canada

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

Jul 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Nov 2020Estimated

Completion Date

Nov 2025Estimated

First Submitted Date

Nov 27, 2008

First Submission Date that Met QC Criteria

Nov 28, 2008

First Posted Date

Dec 1, 2008Estimated

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

Jul 23, 2015

Last Update Posted Date

Jul 27, 2015Estimated

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

The investigators hypothesize that conformal radiation will allow the administration of higher doses of external beam radiation to marrow based malignancies than total body irradiation (TBI)without increasing the toxicity to normal tissues beyond that induced by TBI. Further,the investigators hypothesize that this will result in an improvement in disease response and disease control for patients with multiple myeloma. This is a dose escalation study of TMI with the primary objective of determining the maximum tolerated dose of TMI when followed by aHSCT in patients with 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 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

27Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment	Experimental	Treatment with TMI and autologous Stem Cell transplant	Radiation: Total Marrow Irradiation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Total Marrow Irradiation	Radiation	Total Marrow Irradiation delivered by chemotherapy delivered to cohorts of patients in a dose escalation. The initial cohort will receive 14 Gy. If tolerated subsequent cohorts will receive an additional 2 Gy until the maximum tolerated dose or 28 Gy is reached.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine the maximum tolerated dose of TMI when followed by aHSCT in patients with relapsed or refractory multiple myeloma		30 days from the time of aSCT

Secondary Outcomes

Measure	Description	Time Frame
The frequency and timing of engraftment following TMI and aHSCT		within 30 days of aHSCT
The early morbidity and mortality associated with TMI and aHSCT		30 days from aHSCT

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A subject must meet all of the following criteria to be eligible for the study. These will be evaluated within the four weeks prior to enrolment.
Subject must have primary refractory or relapsed multiple myeloma.
Subject must have a measurable serum or urine monoclonal gammopathy at the time of their latest relapse.
Subject must meet institutional guidelines for autologous HSCT with adequate renal, cardiac, pulmonary and hepatic function.
An autologous hematopoietic stem cell graft containing more than 2.5 x 106 CD34+ cells/kg must be cryopreserved and available for transplantation.
Subject must be of age more than 18 and less than 60 years.
Subject must have an ECOG performance score of 0,1, or 2.
Subject must have the ability to comply with the protocol visit schedule and other protocol requirements.

Exclusion Criteria:

A subject meeting any of the following criteria is not eligible for participation in the study:
Subject with non-secretory multiple myeloma or any plasma cell disorders other that MM.
Subjects that have not received previous therapy with adequate intense corticosteroids for multiple myeloma.
Subjects with a severely limited life expectancy by concomitant illness, defined as a life-expectancy of less than 6 months.
Subjects who have previously received radiation treatments or other neoplastic disorders.
Subjects with a history of non-compliance in other studies.
Pregnant or lactating female subjects.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D009101	Multiple Myeloma
D012008	Recurrence

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