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Dr Andrea Hodgkinson
+44 (0)121 371 4365
a.hodgkinson@bham.ac.uk


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Be Part of Research - Trial Details - A randomised trial of daratumumab to remove myeloma cells from blood stem cells before an autograft for patients with multiple myeloma
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A randomised trial of daratumumab to remove myeloma cells from blood stem cells before an autograft for patients with multiple myeloma

Stopped

Open to: All Genders

Age: Adult

London London Southampton Glasgow Plymouth Sheffield Cambridge Leicester London Birmingham Manchester London Nottingham Bristol Newcastle Leeds Manchester London

Medical Conditions

Newly diagnosed multiple myeloma

This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.


Despite the introduction of new drugs for the treatment of multiple myeloma (MM), autologous stem cell transplant (ASCT) is still considered the best therapy for a large proportion of all MM patients. Unfortunately, the disease comes back (relapses) in the majority of patients who undergo an SCT due to residual plasma cells (myeloma cells) either in the blood stem cells collected during the separation of cells in preparation for the transplant, or remaining in the bone marrow despite all treatments. Patients will commonly receive stem cells that are contaminated with myeloma cells which can reduce the effect of chemotherapy in destroying the myeloma cells pre-transplant. A few studies have investigated strategies to obtain purified stem cell collections in the past, but due to limitations and the poor quality pre-transplant response these approaches have been ineffective. The goal of this trial is to see if the addition of the drug daratumumab to the stem cell collection process and the stem cell transplant can reduce the level of myeloma cells present in the bone marrow 100 days after the transplant and lead to improved long-term outcomes for MM patients.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

18 Jan 2021 18 Jan 2023

The study involves you undergoing an autologous stem cell transplant which can help your disease stay away for longer. Autologous means something, in this case cells, that have come from you rather than someone else.
You will undergo induction therapy after which you will undergo the transplant that is done in 4 parts:
1. Mobilisation – treatment is given to encourage stem cells to move from the bone marrow (where they normally live) and into the blood. There are a few different types of treatment that can be used for this; at your transplant centre it is usually cyclophosphamide and G-CSF (explained in more detail below).
2. Collection (sometimes called harvest) – healthy stem cells are filtered from the blood and stored.
3. Chemotherapy - a high dose of chemotherapy, called melphalan, is given.
4. Transplant – the previously collected stem cells are given back to you by a drip.
In this trial you will undergo the same stages but with the addition of a drug called Daratumumab during the mobilisation and chemotherapy stages. You will be carefully followed up throughput the study.


Anyone who has newly diagnosed multiple myeloma with a greater than or equal to partial response following induction therapy and is considered suitable to undergo a stem cell transplant.

You can take part if:



You may not be able to take part if:


1. Previous treatment with daratumumab or other anti-CD38 therapies2. Demonstrating evidence of progressive disease according to IMWG criteria 3. Peripheral neuropathy above grade 2 as defined by Common Terminology Criteria for Adverse Events (CTCAE) version 5.04. Current or prior malignancy within 5 years from enrolment (other than multiple myeloma, adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or prostate cancer 2 x upper limit of normal (ULN)6. ALT/AST >3 x ULN 7. Known chronic obstructive pulmonary disease (COPD), persistent asthma or pulmonary function tests showing Forced Expiratory Volume (FEV1) <60%8. Known cardiac impairment with Left Ventricular Ejection Fraction (LVEF) <50%9. Pregnant or breast-feeding women. (Women of child-bearing potential and men who are sexually active will be required to undergo the standard testing prior to chemotherapy, which we will not list here for brevity.) 10. POEMS syndrome, plasma cell leukaemia, amyloidosis (AL), smouldering multiple myeloma, Waldenstrom's macroglobulinaemia.11. Known or suspected central nervous system (CNS) involvement by myeloma12. Radiation therapy within 4 weeks of trial entry13. Participation in an investigational therapeutic study within the 4 weeks prior to first dose of daratumumab14. Acute active infection requiring systemic antibiotics, antivirals or antifungals within 2 weeks prior to trial entry 15. Known or suspected human immunodeficiency virus (HIV) infection or subjects who are HIV seropositive 16. Active hepatitis A, B (surface antigen or core antibody positive), or C infection (patients with no detectable virus by PCR may be entered into the study with ongoing monitoring and therapy for viral reactivation as per local practice)17. Serious psychiatric or medical conditions that could, in the investigator’s opinion, interfere with treatment, protocol adherence or a subject's ability to give informed consent


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • University College London Hospital
    University College London Hospitals NHS Foundation Trust 250 Euston Road
    London
    NW1 2PG
  • The Royal Marsden NHS Foundation Trust
    Fulham Road
    London
    SW3 6JJ
  • Southampton General Hospital
    University Hospital Southampton NHS Foundation Trust Tremona Road
    Southampton
    SO16 6YD
  • Gartnavel Royal Hospital
    NHS Greater Glasgow and Clyde J B Russell House 1055 Great Western Road
    Glasgow
    G12 0XH
  • Derriford Hospital
    Derriford Road Crownhill
    Plymouth
    PL6 8DH
  • Northern General Hospital
    Sheffield Teaching Hospitals Nhs Foundation Trust Herries Road
    Sheffield
    S5 7AU
  • Addenbrooke's Hospital
    Hills Road
    Cambridge
    CB2 0QQ
  • Leicester Royal Infirmary
    University Hospitals of Leicester NHS Trust Infirmary Square
    Leicester
    LE1 5WW
  • The Royal London Hospital
    Barts Health NHS Trust 80 Newark Street
    London
    E1 2ES
  • Queen Elizabeth Hospital Birmingham
    University Hospitals Birmingham NHS Foundation Trust Mindelsohn Way
    Birmingham
    B15 2TH
  • Central Manchester University Hospitals NHS Foundation Trust
    Cobbett House Oxford Road
    Manchester
    M13 9WL
  • St Mary's Hospital
    Imperial College Healthcare NHS Trust South Wharf Road
    London
    W2 1BL
  • Queen's Medical Centre
    Nottingham University Hospitals NHS Trust Derby Road
    Nottingham
    NG7 2UH
  • Bristol Royal Infirmary
    University Hospitals Bristol and Weston NHS Foudnation Trust Marlborough Street
    Bristol
    BS1 3NU
  • Freeman Hospital
    Newcastle Upon Tyne Hospital Trust Freeman Road High Heaton
    Newcastle
    NE7 7DN
  • St James’s Hospital
    Leeds Teaching Hospitals NHS Trust Beckett Street West Yorkshire
    Leeds
    LS9 7TF
  • The Christie Hospital
    Wilmslow Road Withington
    Manchester
    M20 4BX
  • King's College Hospital
    King’s Health Partners Clinical Trials Office Denmark Hill
    London
    SE5 9RS

The treatment the patients will receive is the gold standard myeloma treatment which they would receive whether they are on the trial or not with the addition of the fully licensed drug dartumumab. The risks of these therapies have been individually reviewed and considered to be safe and the addition of the two would pose a minimal risk to the patients in the study. This study has been discussed at the NCRI myeloma subgroup (UK Myeloma Research Alliance; UKMRA) who agreed with this assessment.
There will be an early safety review to minimise any possible risk that daratumumab might have.
Treatment with a stem cell transplant is known to be a good way of reducing the amount of myeloma left in the body after chemotherapy and keeping the disease away for longer before treatment is needed again. All patients in the IPANEMA study will receive a transplant. There is a 1 in 2 chance that a patient will be receiving the additional treatment daratumumab, which may be able to improve transplant. However, it is very important to realise that this is not yet known and the aim of this study is to test whether this is true.

Dr Andrea Hodgkinson
+44 (0)121 371 4365
a.hodgkinson@bham.ac.uk



The study is sponsored by University of Birmingham and funded by Leukaemia UK.



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Read full details for Trial ID: ISRCTN40735896

Or CPMS 46959

Last updated 04 January 2023

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