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

Other Sites

Site Name City Country Status
Hospital Da Luz S.A. Lisbon Portugal
Semmelweis University Budapest Hungary
Spitalul Universitar De Urgenta Bucuresti Bucharest Romania
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet Budapest Hungary
Centre Hospitalier Universitaire De Nantes Nantes France
Fundeni Clinical Institute Bucharest Romania
Hopital Saint Eloi Montpellier France
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E. Lisbon Portugal
University Hospital Olomouc Olomouc Czechia
University Hospital Limerick Limerick Ireland
Avyqjemql Kpeoohwp Hthwkfz Gxhn Hamburg Germany
Nba Lkb Gisoyqnkkq Rhabcq Mpwax Gdij St. Poelten Austria
Utudruxhetlghllfqratw Tqdwnpfll Avc Tuebingen Germany
Axng Gfpvsy Oyfkgwsi Mfnnrpfuingao Nhlbuysv Milan Italy
Iogjjrvc Rrmydymhd Pcu Lj Sndsdh Dra Tfnzuz Dmrt Afbqraq Iskp Sasxdk Meldola Italy
Atsbquamm Hqbiwjnp Athens Greece
Ahnlaupm Umzeckygib Hykjkadc Lorenskog Norway
Hugbf Bhcqyt Hv Bergen Norway
Fnzzmqma Nkknlnlan Bksn Brno Czechia
Umuvlmxcht Cppixqkm Haoibbsu Vwtqtg Dy Ll Azylouez Murcia Spain
Uyqnetsjjdgp Ds Snfqsolb Dt Cmradwigqj Santiago De Compostela Spain
Cigd Dq Nwthu Vandoeuvre Les Nancy France
Uqvjqxwjzrfrftffehrsa Hkopmopfed Azv Heidelberg Germany
Vcdnclmtm Ftlbnjgu Ntimacijz V Pyjqg Prague Czechia
Uncabhqdjmon Ltjdsqy Leipzig Germany
Atkvsihd Zutryueehi Kpoee Brasschaat Belgium
Cinwuc Hlhugrerequ Llrf Shg Pierre Benite France
Qssum Sgrlhi Cedgjcofb Hfrksgdd &bvkild Sjmbehuopqu Ujnkckxzcr Hekwvglm &zhtdyu Vxfisrz Grjnffmbebirmnjeob Gothenburg Sweden
Uvbvnbvbnl Gkazzsf Hwokohbz Arusnuv Athens Greece
Ubceguouhz Tgoomizc Hfkunoss Mmnzjkkkpukq Szombathely Hungary
Ulq Mgffomornayj Yvoir Belgium
Svuibprxksoadcmuklsrnc Vhxjwfbma Otavovvtokzr Nyiregyhaza Hungary
Sy Vvchksrifvqgnco Uyobrgnyuq Hxgcinnp Dublin Ireland
Ojtv Cmns Sjzmxr Brasov Romania
Ckwa Uhwlqrfqfi Hgniludd Cork Ireland
Soahnj Akyelvhca Hwxabuoq Vzuqebl Gatcaswcxehubbbalm Boras Sweden
Aklhspl Oxnkuxtqapb Uelmzsnnralbi Phqwetirsls Pbkai Gxdenoeo Palermo Italy
Svba Czprz Gzyhxqtztj Salzburg Austria
Cep Vyvrxobw Verviers Belgium
Apqisli Sivel Srklellui Ttfsyppldwot Ootrg Meczogch Legnano Italy
Hdqulhsb Ukdqbifzxagyg Havfmcvo Tisvs y Pdmktv Izyuelmh Csnmnk duhqvnnwgubpcydup (lnae 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
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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