Study comparing iberdomide, daratumumab and dexamethasone versus daratumumab, bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma

3 1 1 1

What is this study about?

This study focuses on patients with Multiple Myeloma, a type of blood cancer that has either not responded to previous treatment or has returned after treatment (known as relapsed or refractory). The study compares two different combination treatments. The first combination includes Iberdomide (also known as CC-220), Daratumumab, and Dexamethasone. The second combination consists of Daratumumab, Bortezomib, and Dexamethasone.

The purpose of this study is to determine which treatment combination works better in treating patients with relapsed or refractory Multiple Myeloma. The medications are given in different ways – some are taken by mouth as tablets or capsules, while others are given through injection under the skin or into a vein. The treatment will continue as long as it remains beneficial for the patient and side effects are manageable.

During the study, doctors will monitor how well the treatments work by checking the amount of cancer cells in the blood and bone marrow. They will also track how long patients live without their disease getting worse and evaluate the overall survival of patients receiving these treatments. Throughout the study, patients will have regular check-ups to monitor their health and any side effects from the treatments.

1 Initial assessment

Your eligibility for the study will be confirmed based on your multiple myeloma diagnosis and previous treatments

You must have received 1-2 prior treatments for multiple myeloma

You must have shown improvement with at least one previous treatment

Your current physical condition will be evaluated using the ECOG performance status scale

2 Treatment assignment

You will be randomly assigned to one of two treatment groups:

Group 1: IberDd – Iberdomide (capsules taken by mouth) + Daratumumab (injection under the skin) + Dexamethasone (tablets taken by mouth)

Group 2: DVd – Daratumumab (injection under the skin) + Bortezomib (tablets taken by mouth) + Dexamethasone (tablets taken by mouth)

3 Treatment period

Regular assessments will monitor your response to treatment

Blood samples will be taken to measure the level of disease markers

Bone marrow samples will be collected to check for remaining cancer cells

Your overall health and any side effects will be monitored throughout the treatment

4 Follow-up period

Your health will continue to be monitored after completing treatment

Regular checks will track if the disease returns or progresses

Quality of life assessments will be conducted using questionnaires

The study will continue until September 2028

5 Safety requirements

You must follow specific pregnancy prevention measures throughout the study

Blood donation is not permitted during treatment and for 28 days after

Regular pregnancy testing is required for individuals who can become pregnant

Additional safety measures will be explained based on your assigned treatment group

Who Can Join the Study?

  • Must be at least 18 years old
  • Must have been diagnosed with Multiple Myeloma with measurable disease levels
  • Must have received one to two previous treatments for multiple myeloma
  • Must have shown positive response (improvement) to at least one previous treatment
  • Must have evidence that the disease has progressed during or after the last treatment
  • Must have a performance status score of 0, 1, or 2 (measure of patient’s ability to perform daily activities)
  • Must be willing and able to follow the study schedule and requirements
  • Must sign an informed consent form before any study procedures
  • For those who can become pregnant:
    • Must have two negative pregnancy tests
    • Must agree to ongoing pregnancy testing
    • Must use two forms of birth control or practice abstinence
  • For male participants:
    • Must use contraception or practice abstinence during the study and for specified time after
    • Must not donate sperm during the study and for specified time after
  • Must not donate blood during the study and for 28 days after treatment ends
  • Must follow all requirements of the Pregnancy Prevention Program
  • If previously treated with certain medications (CD38-directed therapy):
    • Must have shown positive response to that treatment
    • Must not have had disease progression within 60 days of last dose
    • Must have stopped treatment at least 3 months before joining study

Who Cannot Join the Study?

  • Prior treatment with iberdomide (an experimental drug for multiple myeloma)
  • Active central nervous system involvement of multiple myeloma
  • Known allergy or sensitivity to any of the study medications
  • Previous stem cell transplant within 12 weeks before starting the study
  • Significant heart conditions including heart failure or recent heart attack (within 6 months)
  • Active or chronic liver disease
  • Other types of cancer requiring treatment (except for successfully treated skin cancer or cervical cancer)
  • Uncontrolled high blood pressure
  • Serious infections requiring treatment
  • Pregnancy or breastfeeding
  • Unable to take blood-thinning medications
  • Major surgery within 2 weeks before starting the study
  • Peripheral neuropathy (nerve damage causing numbness or tingling) grade 2 or higher
  • Participation in other clinical trials within 28 days before this study
  • Mental conditions that could interfere with following study procedures
  • Unable to take oral medications

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medical University Of Vienna Vienna Austria
Hospital Universitario De Salamanca Salamanca Spain
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Centre Hospitalier Universitaire De Lille Lille France
Medical University Of Graz Graz Austria
Oncopole Claudius Regaud Toulouse France
Oslo Universitetssykehus HF Oslo Norway
Hospital Universitario Y Politecnico La Fe Valencia Spain
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Centre Hospitalier Departemental Vendee La Roche sur Yon France
Asklepios Kliniken Hamburg GmbH Hamburg Germany
Haga Hospital Hague The Netherlands
Centre Hospitalier Victor Dupouy Argenteuil France
Noe LGA Gesundheit Region Mitte GmbH St. Poelten Austria
Region Sjaelland Holbæk Denmark
University Hospital Ostrava Ostrava Czechia
Beaumont Hospital Dublin Ireland
Odense University Hospital Odense Denmark
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Alexandra Hospital Athens Greece
Fakultni Nemocnice Brno Brno Czechia
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
IRCCS Ospedale Policlinico San Martino Genoa Italy
Turku University Hospital Turku Finland
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Universidade De Santiago De Compostela Santiago De Compostela Spain
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Cracow Poland
Aalborg University Hospital Aalborg Denmark
Azienda Ospedaliero-Universitaria Maggiore Della Carita Novara Italy
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
Hopital Beaujon Clichy France
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
Geniko Nosokomeio Thessalonikis George Papanikolaou Thessaloniki Greece
Stadt Wien Wiener Gesundheitsverbund Vienna Austria
Oulu University Hospital Oulu Finland
Hospital Universitario Virgen De La Victoria Malaga Spain
Centre Henri Becquerel Rouen France
Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego Walbrzych Poland
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Grande Ospedale Metropolitano Bianchi Melacrino Morelli Reggio Calabria Italy
Uniwersytecki Szpital Kliniczny W Bialymstoku Bialystok Poland
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
Champalimaud Clinical Centre Lisbon Portugal
University Hospital Galway Galway Ireland
Universita’ Di Pisa Pisa Italy
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Azienda Ospedaliero-Universitaria Sant Andre Rome Italy
Casa Sollievo Della Sofferenza San Giovanni Rotondo Italy
Soedra Aelvsborg Hospital Vaestra Goetalandsregionen Boras Sweden
St. Olavs Hospital HF Trondheim Norway
Hospital San Pedro De Alcantara Caceres Spain
Region Skane Helsingborg Hospital Helsingborg Sweden
SCRI CCCIT Ges.m.b.H. Salzburg Austria
Albert Schweitzer Ziekenhuis Dordrecht The Netherlands
Olympion Therapeftirio General Clinic Of Patras S.A. Patras Greece
Hezfcesk Vwei ddxtbobb Barcelona Spain
Asypvjsun Uhj Amsterdam The Netherlands
Hrjck Batitp Ht Bergen Norway
Hcxedkeq Ukhbxwftpw Coloccy Hrtbwdfs Helsinki Finland
Cwil Dj Neagc Vandoeuvre Les Nancy France
Akqtyel Upmfq Stizhxefd Lhtede Dy Beeeajg Bologna Italy
Hjoeoghh Dp Lm Swrmj Cpmu I Sgsw Pxr Barcelona Spain
Uzahcmdevm Mtknofq Cqmnjp Hprfbdmaftiysjdea Hamburg Germany
Oaynrlvrgclaqa Llje Gkdc Linz Austria
Hkkuzppi Unduooeqemwae Dn Lf Povdspvl Madrid Spain
Twinezcxct Cgvupi Htogoqim Thessaloniki Greece
Spdtmqq Syxflfjuvcvfawq Icn Jvzfalpj Szupafdwjhzz W Nfigy Sffmu Nowy Sacz Poland
Ngmmasih Ijpkgure Ovgdfmeab Ikr Mghba Scfolhrvcusxtccyugkhouckjkjv Idroxiur Bzhhankh Cracow Poland
Gshtee Uaddizsven Fcvtzaton Frankfurt Germany
Cirz Uvbdssxhko Htawkpjg Cork Ireland
Hrktgvki Uahqnowdottox Hzwwnsrm Tdhmk y Pgfsdq Iyinmerz Cvaxnt duxtlkkwouazyrxhu (vkba Badalona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
11.06.2021
Belgium Belgium
Not recruiting
11.06.2021
Czechia Czechia
Not recruiting
11.06.2021
Denmark Denmark
Not recruiting
11.06.2021
Finland Finland
Not recruiting
11.06.2021
France France
Not recruiting
11.06.2021
Germany Germany
Not recruiting
11.06.2021
Greece Greece
Not recruiting
11.06.2021
Ireland Ireland
Not recruiting
11.06.2021
Italy Italy
Not recruiting
11.06.2021
Norway Norway
Not recruiting
11.06.2021
Poland Poland
Not recruiting
11.06.2021
Portugal Portugal
Not recruiting
11.06.2021
Spain Spain
Not recruiting
11.06.2021
Sweden Sweden
Not recruiting
11.06.2021
The Netherlands The Netherlands
Not recruiting
11.06.2021

Trial locations

Iberdomide (also known as BMS-986382) is a medication being studied for treating relapsed or refractory multiple myeloma. It belongs to a new class of drugs that helps the immune system fight cancer cells.

Daratumumab is an antibody medication that targets specific proteins on myeloma cells. It works by helping the body’s immune system recognize and destroy cancer cells in multiple myeloma.

Dexamethasone is a corticosteroid medication that helps reduce inflammation and suppress the immune system. In multiple myeloma treatment, it is often combined with other medications to enhance their effectiveness.

Bortezomib is a targeted therapy that belongs to a class of drugs called proteasome inhibitors. It works by blocking certain proteins that help cancer cells survive, causing the cancer cells to die.

Investigated Diseases:

Multiple Myeloma – A blood cancer that develops in plasma cells, which are white blood cells that help fight infections. In this condition, cancerous plasma cells accumulate in the bone marrow and crowd out healthy blood cells. These abnormal cells produce large amounts of defective antibodies that build up in the body. The disease typically affects multiple bones in the body, hence its name. Over time, the condition can damage bones, lead to high blood calcium levels, and cause problems with blood cell production. The disease often progresses through cycles of active disease and remission.

Relapsed Multiple Myeloma – A form of multiple myeloma that has returned after a period of remission or response to previous treatment. The disease shows signs of progression after a period when it was under control.

Refractory Multiple Myeloma – A form of multiple myeloma that does not respond to current therapy, or stops responding during treatment. The disease continues to progress despite ongoing treatment efforts.

Trial ID:
2024-510800-35-00
Protocol code:
CC-220-MM-002
Trial Phase:
Therapeutic confirmatory (Phase III)

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