A study of DTP3 for advanced myeloma

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Blood cancers
Myeloma

Status:

Closed

Phase:

Phase 1/2

This study is for people whose myeloma has come back or treatment has stopped working.

More about this trial

There are a number of ways to treat myeloma. But sometimes the myeloma comes back after treatment or stops responding to it.

So doctors are looking at new treatments to help this group of people. In this study, they are looking at DTP3.

DTP3 is a new drug to treat myeloma. It is a biological therapy Open a glossary item that kills myeloma cells but doesn’t affect normal cells. This means that it might have fewer side effects.                    

This is the first time that it is being given to people. The study is in 2 parts.

  • part 1 is trying to find the best dose of DTP3
  • part 2 will test the best dose in a larger number of people

The main aims of the study are to:

  • find the best safe dose of DTP3
  • learn more about the side effects

Who can enter

The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.

You may be able to join this study if all of the following apply. You

  • Have myeloma that has come back or stopped responding to treatment
  • Have myeloma that shows up in blood or urine tests
  • Have had at least 2 treatments for myeloma that included drugs such as thalidomide, lenalidomide and bortezomib
  • Are not suitable to have a stem cell transplant Open a glossary item
  • Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
  • Have satisfactory blood test results
  • Are willing to use reliable contraception during treatment and for 90 days afterwards if there is any chance that you or your partner could become pregnant
  • Are at least 18 years old

You cannot join this study if any of these apply. You

  • Have myeloma in your spinal cord
  • Have had a stem cell transplant in the 3 months before joining the study
  • Have had standard myeloma treatment in the 21 days before joining the study
  • Are having treatment with an experimental drug
  • Have taken part in another clinical trial of an experimental drug in the last 30 days
  • Are taking high dose steroids on a long term basis
  • Might need to have radiotherapy during the study
  • Have plasma cell leukaemia
  • Have a rare blood condition called POEMS syndrome
  • Have a higher risk of developing a bleeding problem or you have a problem with the way your blood clots
  • Have problems with your heart, such as a heart attack or heart surgery in the last 6 months, high blood pressure that is not well controlled, angina that is not well controlled, an abnormal rhythm of your heart or a problem with the valves in your heart
  • Have significant liver disease
  • Had a stroke or have a type of dementia called vascular dementia
  • Have significant numbness or tingling in your hands or feet (peripheral neuropathy Open a glossary item)
  • Have a serious active infection
  • Have HIV
  • Have had any other cancer in the last 5 years apart from very early stage cancer that has been successfully treated such as non melanoma skin cancer Open a glossary item or CIS of the cervix
  • Have any other serious medical condition or mental health problem that the study team think could affect you taking part
  • Are pregnant or breastfeeding

Trial design

This is a phase 1/2 study. The researchers need 58 people to join. The study is in 2 parts. Up to 30 people join part 1 and 28 people join part 2.

In part 1, the first person will have a low dose of DTP3. This dose is increased in the next person if the previous person does not have any serious side effects. This continues until they find the best dose. This is called a dose escalation study.

In part 2 you have the best dose of DTP3 found in part 1.

You have DTP3 as a drip into a vein. It takes about an hour each time. You have treatment 3 times a week. This will probably be on a Monday, Wednesday and Friday. But the study team will give you more details about this.  

You have treatment for as long as it is helping you and the side effects aren’t too bad.

Research samples
You have extra blood tests as part of this study. The researchers want to find out what happens to DTP3 in the body (pharmacokinetics Open a glossary item) and to look for substances called biomarkers Open a glossary item to find out why treatment might work for some people and not for others.

The study team will ask to use samples from bone marrow biopsies and blood tests that you have during the study. They will use the samples to look for biomarkers and to see how well treatment is working.

Hospital visits

You see study doctors and have some tests before you start treatment (screening period). These include:

You go to hospital to have your treatment. You might have to stay overnight after the first treatment to have the blood tests for the pharmacokinetic studies. After that, you shouldn’t need to stay overnight again.

You see the study doctors once a month for a check up and some blood tests. You have a bone marrow test during screening and 2 weeks after starting treatment.

When you stop treatment, you will see the trial team at routine hospital appointments. If you can’t come to clinic, then they will phone you at home every 6 weeks to see how you are getting on.

If you stop treatment but your myeloma hasn’t got worse, you see the doctors once a month until your myeloma gets worse. Your doctor will then talk to you about other treatment options.

Side effects

This is the first time that people are having DTP3. So the study team do not know what the side effects are.

They will monitor you closely during the time you have treatment and you will be given a phone number to call them if you are worried about anything. 

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Jane Apperley

Supported by

Imperial College London
Medical Research Council

 

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

13796

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Charlie took part in a trial to try new treatments

A picture of Charlie

“I think it’s really important that people keep signing up to these type of trials to push research forward.”

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