Study on Alnuctamab and Drug Combination for Patients with Relapsed or Refractory Multiple Myeloma

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What is this study about?

This clinical trial is focused on studying a type of cancer called Multiple Myeloma, which affects the blood and bone marrow. The study is specifically for patients whose cancer has returned or has not responded to previous treatments, known as Relapsed or Refractory Multiple Myeloma. The main treatment being tested in this study is a medication called Alnuctamab, which is being compared to standard treatments that are currently used for this condition. The goal of the study is to determine if Alnuctamab can help patients live longer without their cancer worsening.

Participants in the study will receive either Alnuctamab or one of the standard treatments. The study will monitor how long it takes for the cancer to progress or for the patient to pass away, which is referred to as “progression-free survival.” Researchers will also look at the overall survival of participants, which means how long they live in total. Additionally, the study will assess how well the cancer responds to the treatment, the duration of the response, and the time it takes for patients to start a new treatment. The safety of Alnuctamab and any side effects experienced by participants will also be closely monitored.

The study aims to provide valuable information on whether Alnuctamab is a safe and effective treatment option for people with Multiple Myeloma. The trial is expected to continue until 2031, with recruitment of participants starting in 2024. This research could potentially lead to new treatment options for patients with this challenging condition.

1 joining the study

Upon joining the study, the participant will be informed about the trial’s purpose, procedures, and potential risks and benefits.

The participant will sign an informed consent form, confirming their understanding and willingness to participate.

2 initial assessment

The participant will undergo an initial assessment to confirm eligibility, which includes a documented diagnosis of relapsed or refractory multiple myeloma.

The assessment will also verify that the participant has received prior treatment with lenalidomide and an anti-CD38 monoclonal antibody.

3 randomization

Participants will be randomly assigned to receive either the experimental treatment with alnuctamab or a standard care regimen.

4 treatment phase

Participants receiving alnuctamab will be administered the medication as a solution for injection.

Participants in the standard care group may receive medications such as Empliciti (elotuzumab) as a solution for infusion, DARZALEX (daratumumab) as a solution for injection, Imnovid (pomalidomide) in capsule form, Kyprolis (carfilzomib) as a solution for infusion, and DEXAMETHASONE in capsule form.

The specific dosage and frequency will depend on the assigned treatment regimen.

5 monitoring and follow-up

Participants will be regularly monitored to assess the treatment’s effectiveness and any side effects.

The main focus will be on progression-free survival, which is the time from starting treatment until the cancer worsens or the participant passes away.

Secondary assessments will include overall survival, cancer response to treatment, and quality of life.

6 end of study

The study is estimated to conclude by January 1, 2031.

Participants will have a final assessment to evaluate the overall impact of the treatment.

Who Can Join the Study?

  • Participant must be at least 18 years old or the legal age of consent in the area where the study is happening.
  • Participant must have a confirmed diagnosis of Multiple Myeloma (MM), a type of blood cancer.
  • Participant must have received at least 1 but not more than 3 previous treatments for MM. One treatment can include a series of planned therapies, such as initial treatment, possibly followed by a stem cell transplant, and additional therapies to maintain the response.
  • Participant must have been treated before with lenalidomide, a medication used to treat MM, and an anti-CD38 monoclonal antibody, a type of drug that targets specific proteins on cancer cells, for at least 2 cycles in a row.
  • Participant must have shown at least a minimal improvement in response to at least one previous MM treatment.
  • Participant must have experienced disease progression, meaning the cancer got worse, during or after their last MM treatment, or did not respond to the treatment.
  • Participant must have measurable disease, which means the cancer can be measured by tests. This includes having at least one of the following:
    • Myeloma (M)-protein levels of at least 0.5 grams per deciliter in the blood.
    • At least 200 milligrams of protein in a 24-hour urine collection.
    • Serum free light chain levels greater than 100 milligrams per liter, with an abnormal ratio of kappa to lambda light chains, in participants without detectable M-protein in blood or urine.

Who Cannot Join the Study?

  • Patients who have not been diagnosed with relapsed or refractory multiple myeloma. This means the cancer has returned after treatment or has not responded to treatment.
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the specific clinical trial group being studied.
  • Patients who are not male or female, as both genders are included in the study.
  • Patients who are considered part of a vulnerable population. This refers to groups of people who might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medizinische Universitaet Innsbruck Innsbruck Austria
Technische Universitaet Dresden Dresden Germany
Oslo Universitetssykehus HF Oslo Norway
Hospital Universitario Y Politecnico La Fe Valencia Spain
Medical University Of Vienna Vienna Austria
Hospital Universitario De Salamanca Salamanca Spain
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Centre Hospitalier Universitaire De Lille Lille France
Universitaet Leipzig Leipzig Germany
Oncopole Claudius Regaud Toulouse France
Katholieke Universiteit te Leuven Leuven Belgium
Hospital Universitario De Navarra Pamplona Spain
Hospital Jerez de la Frontera Jerez De La Frontera Spain
Unidade Local De Saúde De Santa Maria, E.P.E. Lisbon Portugal

Other Sites

Site Name City Country Status
Asklepios Kliniken Hamburg GmbH Hamburg Germany
Noe LGA Gesundheit Region Mitte GmbH St. Poelten Austria
Algemeen Ziekenhuis Klina Brasschaat Belgium
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Italy
University Hospital Limerick Limerick Ireland
SCRI CCCIT Ges.m.b.H. Salzburg Austria
CHR Verviers Verviers Belgium
Azienda Socio Sanitaria Territoriale Ovest Milanese Legnano Italy
Soedra Aelvsborg Hospital Vaestra Goetalandsregionen Boras Sweden
University Teaching Hospital Markusovszky Szombathely Hungary
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Alexandra Hospital Athens Greece
Hospital Da Luz S.A. Lisbon Portugal
Fakultni Nemocnice Brno Brno Czechia
Semmelweis University Budapest Hungary
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E. Lisbon Portugal
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Universidade De Santiago De Compostela Santiago De Compostela Spain
Spitalul Universitar De Urgenta Bucuresti Bucharest Romania
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhaza Hungary
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet Budapest Hungary
Centre Hospitalier Universitaire De Nantes Nantes France
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
St Vincent’s University Hospital Dublin Ireland
Onco Card S.R.L. Brasov Romania
University Hospital Olomouc Olomouc Czechia
Centre Hospitalier Lyon Sud Pierre Benite France
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Hopital Saint Eloi Montpellier France
Fundeni Clinical Institute Bucharest Romania
Cftg Umjnqfwvgr Hwxqesyj Cork Ireland
Ivehktjk Rjepoqhqm Pdf Lt Slbcmz Dlr Tolgbz Daif Aqforeu Ijth Sqhpdx Meldola Italy
Acksrzfr Upmtmtkzpq Hkpeauaq Lorenskog Norway
Hminr Bwrfmg Ho Bergen Norway
Urd Mtekxgrqnmqy Yvoir Belgium
Cgpo Dg Nstjz Vandoeuvre Les Nancy France
Hludqrto Udnkxwmukmtcw Huzeorcm Txwxh y Purwjy Iofsmyqi Cwxhbj dgqgrcouifwwuqpwt (paht Badalona Spain
Uieehdkvlh Gjzbyuc Hjacqwfp Ashaiwz Athens Greece

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
01.03.2024
Belgium Belgium
Not recruiting
01.03.2024
Czechia Czechia
Not recruiting
01.03.2024
France France
Not recruiting
01.03.2024
Germany Germany
Not recruiting
01.03.2024
Greece Greece
Not recruiting
01.03.2024
Hungary Hungary
Not recruiting
01.03.2024
Ireland Ireland
Not recruiting
01.03.2024
Italy Italy
Not recruiting
01.03.2024
Norway Norway
Not recruiting
01.03.2024
Portugal Portugal
Not recruiting
01.03.2024
Romania Romania
Not recruiting
01.03.2024
Spain Spain
Not recruiting
01.03.2024
Sweden Sweden
Not recruiting
01.03.2024

Trial locations

Alnuctamab is a medication being studied to see if it can help people with relapsed or refractory multiple myeloma live longer without their cancer getting worse. It is being compared to standard treatments to evaluate its effectiveness and safety.

Investigated diseases:

Relapsed and/or Refractory Multiple Myeloma – This is a type of blood cancer that affects plasma cells, which are a kind of white blood cell found in the bone marrow. In this condition, the cancer has returned after treatment (relapsed) or does not respond to treatment (refractory). It typically progresses by causing damage to bones, kidneys, and the immune system. Patients may experience symptoms such as bone pain, fatigue, and frequent infections. The disease can lead to high levels of calcium in the blood, anemia, and kidney problems. As it advances, it becomes more challenging to manage and requires different treatment strategies.

Trial ID:
2023-509472-42-00
Protocol code:
CA058-1019
Trial Phase:
Therapeutic confirmatory (Phase III)

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