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

NCT04234022 | Recruiting

• 1 other identifier: 2019HAE109
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

• Imuthiol and zinc efficacy

  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

  Cell kill and determination of IC50 (inhibitory concentration) and apoptotic pathways involved

  7 days

Study Arms (3)

Zn-DDC

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

Drug: Zn-DDC

Lenalidomide with Zn-DDC

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

Drug: Lanalidomide with Zn-DDC

Pomalidomide with Zn-DDC

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

Drug: Pomalidomide with Zn-DDC

Interventions

Zn-DDC DRUG

Zn-DDC added to myeloma samples for culturing

Zn-DDC

Lanalidomide with Zn-DDC DRUG

Lanalidomide with Zn-DDC added to myeloma samples for culturing

Lenalidomide with Zn-DDC

Pomalidomide with Zn-DDC DRUG

Lanalidomide with Zn-DDC added to myeloma samples for culturing

Pomalidomide with Zn-DDC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Pregnant patients will not be entered

Sponsors & Collaborators

• University of Wolverhampton: collaborator
• The Royal Wolverhampton Hospitals NHS Trust: lead

Study Sites (1)

The Royal Wolverhampton NHS Trust

Wolverhampton, WV10 0QP, United Kingdom

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

pomalidomide

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Supratik Basu

  The Royal Wolverhampton NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Supratik Basu

CONTACT

01902307999; supratik.basu@nhs.net

Lorraine Jacques

CONTACT

01902695065; lorraine.jacques@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: January 21, 2020
• Study Start: October 22, 2021
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)