Trials Sponsors Conditions Drugs Pricing

Conditions

Myelodysplasia

Keywords

Myelodysplasia

Outcome Measures

Primary Outcomes (1)

Establish the maximally tolerated dose of bortezomib, up to 1.3 mg/m2/day, that can be administered in combination with lenalidomide in patients with primary and secondary non 5q del myelodysplasia who are untreated or previously treated.
3, 6 and 9 months

Secondary Outcomes (6)

Assess efficacy in terms of the number of patients experiencing a decrease in blast percentage
3, 6 and 9 months
Assess efficacy in terms of the number of patients experiencing a decrease in transfusion requirements
3, 6 and 9 months
Determine the toxicity profile of bortezomib when used in combination with lenalidomide for patients with myelodysplasia
3, 6 and 9 months
Determine the time (days) to transfusion independence
3, 6 and 9 months
Determine the duration of response
3, 6 and 9 months
+1 more secondary outcomes

Study Arms (1)

1

EXPERIMENTAL

This is a Phase I dose escalation trial with three cohorts of 3-6 patients each plus 10 additional patients (up to a maximum total of 28 patients) treated at the candidate maximum tolerated dose.Cohorts will receive increasing doses of bortezomib at 0.7, 1, and 1.3 mg/m2 on days 1, 4, 8, and 11 in combination with lenalidomide at 10 mg a day for Days 1-21. Each cycle will be 28 days. Patients will receive up to 9 cycles of treatment, with efficacy assessed after 3, 6, and 9 cycles.

Drug: BortezomibDrug: Lenalidomide

Interventions

BortezomibDrug

First cohort: Bortezomib 0.7mg/m2 IV on Days on Days 1, 4, 8, and 11. Patients may receive up to 9 cycles with each cycle lasting a total of 28 days

Also known as: Velcade

BortezomibDrug

Second cohort: Bortezomib 1mg/m2 IV on Days 1, 4, 8, and 11 Patients may receive up to 9 cycles with each cycle lasting a total of 28 days

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Patients may be untreated or previously treated.
Age \> 18 years

Sponsors & Collaborators

Celgene Corporation
Industrycollaborator
Massachusetts General Hospital
Otherlead
Dana-Farber Cancer Institute

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

MeSH Terms

Conditions

Anemia, Refractory, with Excess of Blasts

Interventions

BortezomibLenalidomide

Condition Hierarchy (Ancestors)

Anemia, RefractoryAnemiaHematologic DiseasesHemic and Lymphatic DiseasesMyelodysplastic SyndromesBone Marrow Diseases

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic Chemicals

Study Officials

Karen Ballen, MD
Massachusetts General Hospital
PRINCIPAL INVESTIGATOR

Enrollment

23 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Director, Leukemia Program

Study Record Dates

First Submitted

December 20, 2007

First Posted

December 24, 2007

Study Start

November 2007

Date type not reported

This date has not been verified as actual or estimated.

A Phase 1 Dose Escalating Trial of Bortezomib in Combination With Lenalidomide in Patients With Myelodysplasia

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (1)

1

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (1)

1

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations