Non-Myeloablative Allogeneic Transplantation From Unrelated Donors in Multiple Myeloma

  • STATUS
    Recruiting
  • participants needed
    100
  • sponsor
    Azienda Ospedaliera San Giovanni Battista
Updated on 7 November 2020
cell transplantation

Summary

The protocol aims at reducing transplant toxicity and mortality in patients with multiple myeloma.

Description

Primary end points are engraftment and non-relapse mortality. Secondary end points are disease response, overall survival, progression and event free survivals. Patient eligibility criteria. Inclusion criteria included: - Diagnosis of Durie-Salmon stage IIA-IIIB multiple myeloma - Age > 18 and ≤ 65 years at the start of the donor search - Presence of concurrent co-morbidities precluding myeloablative conditioning or refusal to undergo a conventional allogeneic transplant - Capacity to give informed consent Exclusion criteria included: - Age > 65 years - Karnofsky performance status score < 60% - Progressive disease or stable disease for less than three months - Central nervous system (CNS) involvement - Left ventricular ejection fraction < 35% or symptomatic heart failure - Poorly controlled hypertension - Pulmonary dysfunction with diffusing capacity for carbon monoxide (DLCO) < 40% and/or need for continuous oxygen supplementation - Abnormal liver disease with a serum bilirubin greater than twice normal or SGOT and/or SGPT greater than four times the upper limits of normal - HIV positive patients - Pregnancy - Refusal to use contraceptive techniques during and for 12 months following treatment Informed consent is obtained during study registration from each patient according to the Institutional Review Boards of the participating centers. The study is conducted according to the Declaration of Helsinki.

Details
Condition Multiple Myeloma
Treatment Hematopoietic Cell Transplantation, Transplantation
Clinical Study IdentifierNCT00327314
SponsorAzienda Ospedaliera San Giovanni Battista
Last Modified on7 November 2020

Eligibility

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note