Clinical trial NCT03159845: Zinc as Enhancer in Immune Recovery After Stem Cell Transplantation for Hematological Malignancies
Official title: A Mono-centric, No-profit, Case-control Study With Daily Oral Supplementation of Zinc Sulphate After Autologous Stem Cell Transplantation in Patients Affected by Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stem Cell Transplant Complications
Keywords: zinc
Lead sponsor: Azienda Ospedaliero, Universitaria Pisana
Sponsor class: OTHER
First posted: 2017-05-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Case-control study, open, without placebo
Primary purpose: SUPPORTIVE_CARE

Brief summary: Patients affected by multiple myeloma undergone autologous stem cell transplantation (SCT) are enrolled at the moment of stem cell collection. They are randomized 1:1 in two groups at the moment of the graft. Patients of the Control group take only standard antimicrobial prophylaxis after SCT; the Sample group takes in addition a daily oral supplementation of Zinc Sulfate (600 mg/die) from day +5 until day +100 after SCT. Laboratory tests are performed on peripheral blood samples.

Detailed description: Patients affected by multiple myeloma undergone autologous stem cell transplantation (SCT) are enrolled at the moment of stem cell collection. They are randomized 1:1 in two groups at the moment of the graft. Patients of the Control group take only standard antimicrobial prophylaxis after SCT; the Sample group takes in addition a daily oral supplementation of Zinc Sulfate (600 mg/die) from day +5 until day +100 after SCT. The aim of the study is to investigate the immune reconstitution in presence of Zinc, focused on thymic reconstitution. Laboratory tests are performed on peripheral blood samples, collected at 4 time-points: two before transplant (at the moment of the enrollment and the day before conditioning) and two after transplant (day +30 and +100).

Eligibility criteria: Inclusion Criteria:

* eligibility to stem cell transplantation

Exclusion Criteria:

* allergy to Zinc
* copper deficiency or Wilson's syndrome
* patients who admit zinc assumption in other drugs

Primary outcomes:
measure: Thymic output improvement by TRECs
timeFrame: increase of TRECs levels from day +30 until day +100 after transplant
measure: Thymic output improvement by flow cytometry
timeFrame: days +30, +100 after transplant
Secondary outcomes:
measure: Variations in circulating lymphocyte populations
timeFrame: days +30, +100 after transplant
measure: Immune competence
timeFrame: days +30, +100 after transplant
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: days +30, +100 after transplant
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: Hematology UO
Study officials:
References:
citation: Iovino L, Mazziotta F, Carulli G, Guerrini F, Morganti R, Mazzotti V, Maggi F, Macera L, Orciuolo E, Buda G, Benedetti E, Caracciolo F, Galimberti S, Pistello M, Petrini M. High-dose zinc oral supplementation after stem cell transplantation causes an increase of TRECs and CD4+ naive lymphocytes and prevents TTV reactivation. Leuk Res. 2018 Jul;70:20-24. doi: 10.1016/j.leukres.2018.04.016. Epub 2018 May 2.