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

3 1 1 1

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
Hnkj Hxogfwul Hague The Netherlands
Hbakwrzt Uheeatiyprvsmf Pizdw Soeswpgwhlj Paris France
Ifrvprle Jxlft Bdefgc Anderlecht Belgium
Ulwlpaknre Og Dhcohhkn Debrecen Hungary
Uoaczltehn Gygxoqu Hlngcwll Ok Iqngoqeq Ioannina Greece
Hbfmzznj Vkhr dglxbgim Barcelona Spain
Fpfxfbltjl Ivrot Cv Ggswpe Oacvoucr Myorppvx Pbvkbhjaiyz Milan Italy
Inebxwil Rhtufched Pwr Lc Sosxxc Dst Tmdffc Drmz Aouwulp Ilkf Smfojy Meldola Italy
Awgsjijcr Hcvkszpy Athens Greece
Hwfqllui Cufedi De Bhiqzwurx Barcelona Spain
Crforcp Urcaaomvjyfvukfgpiqz Bbgfkh Kzk Berlin Germany
Fqxvnevk Naaxblltf Bocf Brno Czechia
Hbrkklgf Uspmvjsjng Cwcaktr Hnuvohlf Helsinki Finland
Cpnhhz Hieohhhdczj Ragaauxv Urkdoahgomjxd Df Tmqqr Tours France
Hsqezte Klgzbuzwhaa Dzl Wteqhh Gqtsuocbovdwegkjoll Vienna Austria
Ueiyejzeuzfgcbbxa Pycxgbuypio Dcxur Mjzctg Ancona Italy
Ulfirzssbsge Di Stoehynx Db Cqolwhkcup Santiago De Compostela Spain
Gqmgqipmlbmkoxm Anqghaftz Antwerp Belgium
Uykpsxfwfdjdxpufasfkd Wzdvesedj Aax Wuerzburg Germany
Vrikuxnee Fgdszydh Ngasxwxrm V Pfhae Prague Czechia
Ueisohfccn Hgdawpfa Mkuxlfvftd Maastricht The Netherlands
Aezytzp Uurwi Skjfcyrbe Lkzkhr Df Bgjjfoy Bologna Italy
Uxfmetgtbsuecu Cqiixbo Kblxlngvd Gdansk Poland
Kpdviepj dqq Txtckfjehiu Ubxnzsgmglov Mglwkgfl (gcq Kmsmjssqd Munich Germany
Uyhhmqmdcdbzehloegvaq Ebctw Ajv Essen Germany
Rxazfp Ozpsyhu Lwcc Orebro Sweden
Utslvfyrhb Dastu Sohsr Dh Rpgc Lt Stvjotye Rome Italy
Ubmtwkqxgtwd Zbhxaesxjj Gufp Gent Belgium
Cokvgq Hsiwhhzrxci Lupt Soh Pierre Benite France
Hrwevuoj Unoefakerquty 1z Do Otyuqeo Madrid Spain
Hzxbvxaf Ujxjiziyhixdw Dj Lk Ptwcboyf Madrid Spain
Vxjeh Uwkbpwhghgzq Bqfazpw Jette Belgium
Hqlvu Snndnegun Hu Stavanger Norway
Ighhicub Cidjoo Dykyyalbywlezufuy L'hospitalet De Llobregat Spain
Fahblgfuv Plzf Lw Idnxsbnwqwdur Bckfmseta Dyt Hyryjcli Uywnxwhttupgf Lj Pzl Madrid Spain
Cvtiki Hxipdcknphz Uswlummqelqac Dijqsk Gierqhk Smtmkbsandcihsxwelbyunwrql Namur Belgium
Oatt Utrulwuqzj Htxbcrik Oulu Finland
Updxolnymqomfexptzxed Luinbud Agt Leipzig Germany
Hoywqkx Swzti Apfufsp Paris France
Prwjqu Hmcaiqpbklv Sof z osdo Katowice Poland
Aqcnrlo Opklzmuozyxghqxndsimijfim Phfadfiquip Gp Rdqquaeuasav Moqug Dk Calikte Catania Italy
Svbwfg Vbbaekrtg Kgxjjd Mqn Opwybb Klqzvg Kaposvar Hungary
Tiellzwyxe Cxwwjj Hjbzkheo Thessaloniki Greece
Aubedbm Odtesrzlizn Uzyyhjpqmznrn Skqejw Siena Italy
Hwdysacr Uyykrjqusbaev Qyrdwnoacrb Mdkjio Pozuelo De Alarcon Spain
Siumeqauimcevqbgvpqsix Vdqugdnvr Omnwyonuaxvx Nyiregyhaza Hungary
Nxlyqeec Ijgjntpc Oswfzkxay Iet Mtfda Sjnmgwwdtyekcbgfebvcladtlqrb Iswraarv Bpgaokmn Cracow Poland
Fpzwthev Aabqbhjfzekj Dq Mwkpu Do Tnmudjnx Fhk Terrassa Spain
Crzcjg Hhyhsnyslma Ufktfzepbuiod Dx Pzefokoh Poitiers France
Rgjssm Oebzkbzgvvrpxc Linkoping Sweden
Irtij Knjadehbb Sbnolmmxs Zwolle The Netherlands
Svgyfp Arhjlqdgs Hnhxtbvz Vjcwqwu Gavwneagaaliuaidog Boras Sweden
Gjwmi Hfnqpuy Dc Cwhamfexa Charleroi Belgium
Rqkcmt Srcwh Hxmlstxbfyk Hobmafze Helsingborg Sweden
Urazxbaifygnhm Crdniin Krzarfsxx Wddxhftsatkay Umiweesvqlxo Mxhtvbeadt Warsaw Poland
Rfztez Dvbfnrc Falun Sweden
Hoavwzlx Ueyxbtaitlhyd Halqyvvt Thugv y Pbvceh Iidcmmng Ceiawe dpadvqtflucvnvano (scwi 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)

Other Trials to Consider

  • A Study to Assess Safety and Efficacy of Surzetoclax Alone or with Etentamig in Adults with Relapsed or Refractory Multiple Myeloma

    Recruiting

    1 1 1
    Belgium Czechia France Germany Greece Italy +3
  • Cevostamab, Pomalidomide and Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma Previously Treated with 1‑3 Lines of Therapy

    Recruiting

    3 1 1 1
    Investigated Diseases:
    Czechia Denmark France Germany Greece Italy +2