Study Comparing Elranatamab and Lenalidomide for Patients with Newly Diagnosed Multiple Myeloma After Stem-Cell Transplantation

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What is this study about?

This clinical trial is focused on studying Multiple Myeloma, a type of cancer that affects plasma cells in the bone marrow. The study is comparing two treatments for patients who have been newly diagnosed with this condition and have undergone a procedure called autologous stem-cell transplantation, which involves using the patient’s own stem cells to help restore bone marrow. The treatments being compared are Elranatamab, also known by its code name PF-06863135, and Lenalidomide, which is available in different dosages under the brand name Zelvina.

The purpose of the study is to evaluate how effective Elranatamab is compared to Lenalidomide in treating patients with Multiple Myeloma. Participants in the study will be randomly assigned to receive either Elranatamab or Lenalidomide. Elranatamab is administered as a solution for injection under the skin, while Lenalidomide is taken orally in capsule form. The study will monitor the participants over a period of time to assess their response to the treatment and any side effects they may experience.

Throughout the study, participants will have regular check-ups and tests to track their health and the progress of their Multiple Myeloma. The main goal is to determine which treatment helps patients live longer without their disease getting worse. This information will help doctors make better treatment decisions for future patients with Multiple Myeloma.

1 randomization

Upon joining the study, participants are randomly assigned to one of two groups. One group receives elranatamab, and the other group receives lenalidomide.

2 elranatamab administration

Participants in the elranatamab group receive the medication through a subcutaneous injection. The specific dosage and frequency are determined by the study protocol.

3 lenalidomide administration

Participants in the lenalidomide group take the medication orally. The study uses Zelvina capsules, available in 15 mg, 5 mg, and 10 mg doses. The exact dosage and frequency are specified in the study protocol.

4 additional treatments

Some participants may receive human normal immunoglobulin through an IV infusion as part of their treatment plan. This is administered as Privigen 100 mg/ml solution for infusion.

5 monitoring and assessments

Throughout the study, participants undergo regular monitoring and assessments to evaluate their health and the effectiveness of the treatment. This includes laboratory tests and other procedures as outlined in the study protocol.

6 study duration

The study is expected to continue until October 31, 2029. Participants remain in the study for the duration specified in the protocol, unless they choose to withdraw or are advised to stop for medical reasons.

Who Can Join the Study?

  • Participants must be at least 18 years old, or the minimum age of consent in their country if it’s higher than 18.
  • Both male and female participants of childbearing potential must agree to use birth control.
  • Participants should be willing and able to attend all scheduled visits, follow the treatment plan, and complete all required tests and procedures.
  • Participants must have a diagnosis of Multiple Myeloma with measurable disease, as defined by specific criteria involving blood and urine tests.
  • Participants should have achieved a partial response or better to previous treatment, according to specific criteria.
  • The main cancerous cell type must be identified through a specific laboratory test.
  • Participants should have an ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but can still carry out light work.
  • The heart’s ability to pump blood, measured as left ventricular ejection fraction, should be at least 40%.
  • Liver function should be adequate, with specific limits on liver enzymes and bilirubin levels.
  • Kidney function should be adequate, with a specific measure of how well the kidneys filter blood.
  • Participants must have recovered from any previous treatments, with blood cell counts and hemoglobin levels meeting specific criteria.
  • Calcium levels in the blood should be within a certain range.
  • Participants must be able to understand and sign a consent form, agreeing to follow the study’s requirements and restrictions.

Who Cannot Join the Study?

  • Patients who have had another type of cancer in the past, except for certain skin cancers or cervical cancer that has been treated.
  • Patients who have an active infection that requires treatment with antibiotics, antivirals, or antifungals.
  • Patients who have a history of severe allergic reactions to similar medications.
  • Patients who have a serious heart condition, such as heart failure or a recent heart attack.
  • Patients who have uncontrolled high blood pressure.
  • Patients who have a condition that affects their immune system, like HIV or AIDS.
  • Patients who are pregnant or breastfeeding.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had a major surgery within the last 4 weeks.
  • Patients who have a history of drug or alcohol abuse within the past year.
  • Patients who have a mental health condition that might affect their ability to participate in the study.
  • Patients who have received certain treatments for multiple myeloma in the past.
  • Patients who have any other medical condition that the study doctors think might make it unsafe for them to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
University Hospital Ostrava Ostrava Czechia
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Karolinska University Hospital Solna Sweden
Semmelweis University Budapest Hungary
Turku University Hospital Turku Finland
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet Budapest Hungary
Hospital General Universitario Gregorio Maranon Madrid Spain
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
University Hospital Olomouc Olomouc Czechia
Huue Hbrmjvwv Hague The Netherlands
Hlqrbxsg Umrgxqpkyxdbni Prqza Sgnzqvnyxhc Paris France
Iyvgrvfl Jjrdm Bsjmms Anderlecht Belgium
Utfyoylbcd Oz Dqzhcxnu Debrecen Hungary
Uotjcxjpsv Gohlmxd Hdnbbaol Oj Ijkgbgwc Ioannina Greece
Hzzbwece Vsnw dcnuknei Barcelona Spain
Fklomyjhkj Ivbmk Cl Glhxmw Ootbutez Mccurkrs Pzkfyofsmei Milan Italy
Ijzdozqy Rfdmckuqx Pvc Ls Spfwyl Dcx Tmuxuo Djvo Awtpuks Ifid Sfnbei Meldola Italy
Adwtkzhzp Hgrvbsox Athens Greece
Hndjykxk Czxcxv Dl Bgovplpfo Barcelona Spain
Cruqqyp Ulhqbombphzlfwollyas Bglfll Kda Berlin Germany
Fzlszzec Nycnobubn Bdor Brno Czechia
Hmrcrdeb Uxjfvnaoej Cpmpwaf Hwyckvyb Helsinki Finland
Ctbiqj Hnidfedevbz Rngekztq Uuqgskknscyaw Dm Tprrk Tours France
Hduwazr Knsvdsrsqff Doz Wmmjvl Ghgwcujgtrlowylwmvn Vienna Austria
Uasaujyeoojniglgf Pmsmgnwjfvu Dfmyy Mipaxq Ancona Italy
Uwfmofudxuog Dp Seizrrda Di Ceowvrkpcv Santiago De Compostela Spain
Gzuadyirdfiigmm Apelgfuoq Antwerp Belgium
Uefrjimyyxchrnmojrzsb Wybabumze Aeu Wuerzburg Germany
Vtbakqwsv Fieuimnt Norouczlh V Pqjps Prague Czechia
Unaoychmsp Hfbhomyw Majjakopqd Maastricht The Netherlands
Aplncbs Uowqv Szfhlucke Lhcgan Dy Bffwrnl Bologna Italy
Umxzowzgdqwxhd Ciaaqpi Kzseyqfdj Gdansk Poland
Knziqhgv ddx Tvqmjgsaxch Upgbdsukzqch Mjupdupc (szi Kyyaxjiit Munich Germany
Utvtxjuktuxjjmpooitbv Ecqyx Aau Essen Germany
Rolghg Onoftkp Lwht Orebro Sweden
Uaahsgxpfj Dxxtz Slwas Do Rnqt La Ssuginlq Rome Italy
Ujxkrmqtmewh Zbgbaqwjug Ghaa Gent Belgium
Crncmy Haopeweitha Lcpo Sha Pierre Benite France
Hcckuiaj Ufdeitoorrppf 1q De Ouhmuec Madrid Spain
Hvxukpwy Ucpgdqiklqfix Dp Lc Pjuebiny Madrid Spain
Vucqq Uhjeoovzlrlw Bjscnes Jette Belgium
Hearq Suzjfctsr Hb Stavanger Norway
Ihectykf Ccbblx Dfybabpkmhljnelxb L'hospitalet De Llobregat Spain
Fbulpjdsp Pztp Lp Iztgthtmcpqje Blpijvxlm Dye Htfqczco Uyotxyhpptnae Lp Pxl Madrid Spain
Chshhk Hmeatpuglup Uhzjsmwjwlsnt Dsmjbw Gaybfsz Sqnvqyrtfcgtpqbhhakaiyqvro Namur Belgium
Ouqi Uphyrzabtu Hnnytnmu Oulu Finland
Ulsyueldlkurvxptcslwr Lnkbdnt Agf Leipzig Germany
Hsivbaa Sqkyb Acflmmz Paris France
Poxpvy Hmqyydfuufg Srd z odzo Katowice Poland
Aruvukq Owwzjmtdeewmlfhhftqxlnfcf Pttwmcyyjnb Gj Rtxgtouhfudk Mohms Do Cfelfat Catania Italy
Sjtiyt Vhavnyeaf Klasio Myp Osrzkm Keeiut Kaposvar Hungary
Tdlrbhvrrp Chxihe Hbmmtrbe Thessaloniki Greece
Ausneai Oqutjslbuzi Umfetybblaang Srqzqk Siena Italy
Hslbmtfg Uhcxojhlhbdqf Qbanobehavr Mbtokr Pozuelo De Alarcon Spain
Sbwiaemgnhnchgfwcjqurv Viowpydwo Oqpeixxyyldh Nyiregyhaza Hungary
Nkpscoqx Iezcsphs Oktwdikjg Izj Mvoac Svytsupkbivdcsqtspvmrbvswhcj Ietlachn Bynbyipa Cracow Poland
Frfniorv Akyakyqkeysd Dk Minkk Dy Tibmrhzc Fcj Terrassa Spain
Cjylqc Haomspfbqjk Ulfwriwhnwqlf Dd Pojjokte Poitiers France
Rtvehx Odsjskbrwoffnb Linkoping Sweden
Ievcw Kduzojttj Sftwblump Zwolle The Netherlands
Sfqbix Aggehmycr Hbprqnrw Vidsmsw Ghitlejowhaboqdnmx Boras Sweden
Gmngc Hnepyxf Dn Cibvblrqi Charleroi Belgium
Rhtybi Svzje Hbfhfybwdff Hcnuvunc Helsingborg Sweden
Uwbntdztrduwso Csxmgjo Kcggcfpzy Wqcvstfxkdllb Uyranrpeayoy Mjgsdodyvb Warsaw Poland
Rzrnfe Dejjepp Falun Sweden
Htiyblre Upuhqzucrmiuc Hbpceynh Tkqgj y Petdgu Iunliyta Cwyrqd djmgyrzdtkqqvunqy (hytc 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
28.04.2022
Belgium Belgium
Not recruiting
28.04.2022
Czechia Czechia
Not recruiting
28.04.2022
Finland Finland
Not recruiting
28.04.2022
France France
Not recruiting
28.04.2022
Germany Germany
Not recruiting
28.04.2022
Greece Greece
Not recruiting
28.04.2022
Hungary Hungary
Not recruiting
28.04.2022
Italy Italy
Not recruiting
28.04.2022
Norway Norway
Not recruiting
28.04.2022
Poland Poland
Not recruiting
28.04.2022
Spain Spain
Not recruiting
28.04.2022
Sweden Sweden
Not recruiting
28.04.2022
The Netherlands The Netherlands
Not recruiting
28.04.2022

Trial locations

Elranatamab is a medication being studied for its effectiveness in treating patients with newly diagnosed multiple myeloma. It is being compared to another treatment to see how well it works in patients who have already undergone a stem-cell transplant. Elranatamab is designed to help the immune system target and destroy cancer cells.

Lenalidomide is a medication used in the treatment of multiple myeloma. It works by affecting the immune system to help slow down or stop the growth of cancer cells. In this study, lenalidomide is being used as a comparison to evaluate the effectiveness of elranatamab in patients who have had a stem-cell transplant.

Investigated Diseases:

Multiple Myeloma – Multiple Myeloma 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 disease, cancerous plasma cells multiply and accumulate in the bone marrow, leading to bone damage and affecting the production of normal blood cells. As the disease progresses, it can cause bone pain, fractures, and anemia due to the reduced production of healthy blood cells. Patients may also experience kidney problems and increased susceptibility to infections. The disease often progresses slowly, but it can become more aggressive over time.

Trial ID:
2023-508897-27-00
Protocol code:
C1071007
NCT ID:
NCT05317416
Trial Phase:
Therapeutic confirmatory (Phase III)

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