Zn-DDC to Target Hypoxia-NFkappaB-CSCs Pathway in Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:

Zn-DDC to Target Hypoxia-NFkappaB-CSCs Pathway and Improve the Treatment Outcomes of Haematological Malignancies - A Translation Bench Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04234022
• Other study ID #: 2019HAE109
• Status: Recruiting
• Start date: October 22, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2023
• Source: The Royal Wolverhampton Hospitals NHS Trust
• Contact: Supratik Basu
• Phone: 01902307999
• Email: supratik.basu[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The outlook for patients with haematological malignancies remains challenging. It has been shown in some early cancer studies that a particular drug called Zn-DDC otherwise known as Imuthiol is highly toxic to cancer stem cells. Imuthiol has been intravenously used in clinical trials with an excellent safety record. Recent novel therapy and immunotherapy in haematological malignancies have improved outcome and survival but come with an increasing cost burden. Imuthiol could be an ideal affordable drug to study on it's own as well as in combination with other drugs in myeloma and other haematological malignancies. This may lead to potential combination therapies which will be very effective as well as affordable in the future. There is the need to look to see if this drug, Imuthiol and along with complementary drugs lenalidomide (Revlimid) and pomalidomide (Pomalyst) can help in haematological malignancy treatment. In order to do this there is the need to see how the cancer cells respond to the drugs in the laboratory before being able to trial the drug (or combination of drugs) out for treatment. The success of this study may lead to quick translation of Imuthiol into haematological malignancy treatment.

Description:

Up to 60 myeloma bone marrow samples from Myeloma patients and 10 bone marrow samples from other haematological malignancy samples (Acute leukaemia's) at Diagnosis and Relapse will be tested.

Patients attending haematology clinics at New Cross Hospital will be reviewed for eligibility of the study by the clinician and if they meet the recruitment criteria, they will be approached to participate at clinic.

After informed consent, participants will be asked to donate an additional 2-3ml sample of bone marrow in a single aliquot for the purpose of this study whilst undergoing a bone marrow aspirate as part of their routine clinical care at diagnosis and relapse.The single aliquot will be sent to the University of Wolverhampton for analysis.

Specific clincial data will be collected at the time of diagnosis and relapse:

• Diagnosis

• Date diagnosed

• Disease stage

• Relapse status

• Age

• Sex

• Previous treatments

• Date of marrow sample

• Marrow trephine

• Marrow liquid The clinical data set will remain at The Royal Wolverhampton NHS Trust whilst analysis of the samples takes place. Once the samples have been analysed, the clinical data will then be released to determine relapsed or refractory disease and correlation with the in vitro data.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients diagnosed with haematological malignancy - either myeloma or acute leukaemia

• Patients must be 18 years or over

• Patients must be willing and able to give informed consent

Exclusion Criteria:

• Pregnant patients will not be entered

Related Conditions & MeSH terms

• Hypoxia
• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Zn-DDC
Zn-DDC added to myeloma samples for culturing
• Lanalidomide with Zn-DDC
Lanalidomide with Zn-DDC added to myeloma samples for culturing
• Pomalidomide with Zn-DDC
Lanalidomide with Zn-DDC added to myeloma samples for culturing

Locations

Country	Name	City	State
United Kingdom	The Royal Wolverhampton NHS Trust	Wolverhampton

Sponsors (2)

Lead Sponsor	Collaborator
The Royal Wolverhampton Hospitals NHS Trust	University of Wolverhampton

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Imuthiol and zinc efficacy	examine the cyctotoxicity of Imuthiol and zinc in combination with other drugs	7 days
Primary	Cell kill and determination of IC50 (inhibitory concentration) and apoptotic pathways involved	Cell kill and determination of IC50 (inhibitory concentration) and apoptotic pathways involved	7 days