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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04234022
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

The Royal Wolverhampton Hospitals NHS Trust
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Supratik Basu
Principal Investigator Affiliation The Royal Wolverhampton NHS Trust
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma
Additional Details

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.

Arms & Interventions

Arms

: Zn-DDC

samples to be exposed with Zn-DDC (Imuthiol) alone

: Lenalidomide with Zn-DDC

samples to be exposed with Lenalidomide in combination with Zn-DDC

: Pomalidomide with Zn-DDC

samples to be exposed with Pomalidomide in combination with Zn-DDC

Interventions

Drug: - Zn-DDC

Zn-DDC added to myeloma samples for culturing

Drug: - Lanalidomide with Zn-DDC

Lanalidomide with Zn-DDC added to myeloma samples for culturing

Drug: - Pomalidomide with Zn-DDC

Lanalidomide with Zn-DDC added to myeloma samples for culturing

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

The Royal Wolverhampton NHS Trust, Wolverhampton, United Kingdom

Status

Recruiting

Address

The Royal Wolverhampton NHS Trust

Wolverhampton, , WV10 0QP

Site Contact

Supratik Basu

supratik.basu@nhs.net

01902307999