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

December 27, 2023 updated by: The Royal Wolverhampton Hospitals NHS Trust

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Zn-DDC
samples to be exposed with Zn-DDC (Imuthiol) alone
Drug: Zn-DDC
Zn-DDC added to myeloma samples for culturing
Lenalidomide with Zn-DDC
samples to be exposed with Lenalidomide in combination with Zn-DDC
Drug: Lanalidomide with Zn-DDC
Lanalidomide with Zn-DDC added to myeloma samples for culturing
Pomalidomide with Zn-DDC
samples to be exposed with Pomalidomide in combination with Zn-DDC
Drug: Pomalidomide with Zn-DDC
Lanalidomide with Zn-DDC added to myeloma samples for culturing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Imuthiol and zinc efficacy
Time Frame: 7 days
examine the cyctotoxicity of Imuthiol and zinc in combination with other drugs
7 days
Cell kill and determination of IC50 (inhibitory concentration) and apoptotic pathways involved
Time Frame: 7 days
Cell kill and determination of IC50 (inhibitory concentration) and apoptotic pathways involved
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Royal Wolverhampton Hospitals NHS Trust

Collaborators

University of Wolverhampton

Investigators

  • Principal Investigator: Supratik Basu, The Royal Wolverhampton NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2021

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

January 15, 2020

First Submitted That Met QC Criteria

January 15, 2020

First Posted (Actual)

January 21, 2020

Study Record Updates

Last Update Posted (Actual)

December 28, 2023

Last Update Submitted That Met QC Criteria

December 27, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019HAE109

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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