NCT01991301

Brief Summary

The aim of this study is to evaluate the safety and efficacy of Carfilzumib, which is a novel biological agent used in the treatment of multiple myeloma in preventing graft-versus-host disease, after stem cells transplantation from unrelated donors.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2014

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
11 months until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

December 2, 2015

Status Verified

December 1, 2015

Enrollment Period

3 years

First QC Date

November 18, 2013

Last Update Submit

December 1, 2015

Conditions

Graft-versus-host Disease

Keywords

graft-versus-host diseasestem cell transplantationmatched unrelated donorsproteosmoe inhibitorcarfilzumib

Outcome Measures

Primary Outcomes (1)

  • incidence of acute graft-versus host disease

    We will evaluate the incidence of acute GVHD, grading and organ involvementBY STANDARD INTERNATIONAL CRITERIA.

    3 months

Secondary Outcomes (2)

  • incidence of chronic graft-versus-host disease

    1 year

  • survival rate

    2 years

Study Arms (1)

carfilzumib

EXPERIMENTAL

Carfilzomib at a dose of 20mg/m2 I.V. will be administrated at day 1, 2 post infusion of the stem cell (SC) graft to the first 10 patients. If no \> grade II toxicity\* the next 10 patients will receive Carfilzomib (27 mg/m2) at day 1,2 and 8, 9, 15 and 16. If no \> grade II toxicity\* the next 10 patients will receive 2-3 cycles of Carfilzomib (27 mg/m2) administered at day 1,2 8,9,15 and 16 post SC graft infusion.

Drug: carfilzumib

Interventions

carfilzumibDRUG

carfilzumib will be added to the standard regimen of drugs for prevention of graft-versus-host disease.

carfilzumib

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with MDS/AML
  • years or older and willing and able to comply with the protocol requirements.
  • LVEF ≥ 40%. 2-D transthoracic echocardiogram (ECHO) is the preferred method of evaluation. Multigated Acquisition Scan (MUGA) is acceptable if ECHO is not available.
  • Patients undergoing 8-10/10 HLA matched unrelated and unmanipulated PBSC transplantation
  • Patients conditioned with reduced intensity or reduced toxicity conditioning i.e. Fludarabine combine with Treosulfan or 2-4 days of I.V Busulfan.
  • Patients must sign written informed consent.
  • Adequate birth control in fertile patients.

You may not qualify if:

  • Patients undergoing other type of transplantation or with other type of basic disease other than AML or MDS.
  • Patients with respiratory failure (DLCO \< 30%).
  • Active congestive heart failure (New York Heart Association \[NYHA\] Class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention.
  • Patients with \> grade II liver renal toxicity.
  • Psychiatric conditions/disease that impair the ability to give informed consent or to adequately co-operate
  • Bilirubin \> 3.0 mg/dl, transaminases \> 3 times upper normal limit
  • Creatinine \> 2.0 mg/dl
  • ECOG-Performance status \> 2
  • Uncontrolled infection
  • Pregnancy or lactation
  • CNS disease involvement
  • Pleural effusion or ascites \> 1 liter.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chaim Sheba Medical Center

Tel Litwinsky, 52621, Israel

RECRUITING

Related Publications (1)

  • Shimoni A, Shem-Tov N, Yerushalmi R, Danylesko I, Nagler A. Carfilzomib combined with cyclosporine and methotrexate for the prevention of graft-versus-host disease after allogeneic stem-cell transplantation from unrelated donors. Bone Marrow Transplant. 2021 Feb;56(2):451-456. doi: 10.1038/s41409-020-01044-5. Epub 2020 Sep 2.

    PMID: 32873915DERIVED

MeSH Terms

Conditions

Graft vs Host Disease

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Arnon Nagler, MD

    Chaim Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Arnon Nagler, MD

CONTACT

972 3 530 5830a.nagler@sheba.health.gov.il

Avichai Shimoni, MD

CONTACT

972 3 530 5830ashimoni@sheba.health.gov.il

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2013

First Posted

November 25, 2013

Study Start

November 1, 2014

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

December 2, 2015

Record last verified: 2015-12

Locations

IL(1)