Study of Elranatamab, Dexamethasone, and Diphenhydramine Hydrochloride for Patients with High-Risk Smoldering Multiple Myeloma

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What is this study about?

This clinical trial is focused on studying a condition known as high-risk smoldering multiple myeloma, which is a type of blood disorder that can potentially develop into a more serious form of cancer called multiple myeloma. The study is investigating the effects of a treatment called Elranatamab, which is a solution for injection developed by Pfizer Inc. The main goal of the study is to determine how effective Elranatamab is in treating patients who have not previously received treatment for this condition.

Participants in the study will receive Elranatamab through subcutaneous injections, which means the medication is administered under the skin. In addition to Elranatamab, some patients may also receive other medications such as Dexamethasone, an oral solution that helps reduce inflammation, Diphenhydramine Hydrochloride, an antihistamine tablet used to relieve allergy symptoms, Paracetamol, a tablet for pain relief and fever reduction, and Tocilizumab, an immunosuppressant given as an intravenous infusion to help control the immune system’s activity.

The study will be conducted over a period of time, with regular monitoring to assess the treatment’s effects and any side effects. The primary focus is to see if patients achieve complete remission, which means the disease is no longer detectable, by the end of the sixth cycle of treatment. The study will also monitor for any significant side effects that may occur. This research aims to provide valuable information on the potential benefits of Elranatamab for patients with high-risk smoldering multiple myeloma.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s purpose and procedures. An informed consent form must be signed to confirm understanding and willingness to participate.

2 initial assessment

The patient will undergo an initial assessment to confirm eligibility. This includes a review of medical history and laboratory tests to ensure all criteria are met.

3 treatment initiation

The treatment begins with the administration of elranatamab through subcutaneous injection. The dosage and frequency will be determined by the study protocol.

4 supportive medications

To manage potential side effects, additional medications may be administered. These include dexamethasone and diphenhydramine hydrochloride taken orally, and tocilizumab given intravenously if needed. Paracetamol may also be used orally for pain relief.

5 monitoring and follow-up

Regular monitoring will occur throughout the study to assess the patient’s response to treatment and any side effects. This includes physical examinations, blood tests, and other necessary evaluations.

6 completion of cycle 6

At the end of cycle 6, the patient’s response will be evaluated based on the International Myeloma Working Group criteria. The primary goal is to assess the complete remission rate.

7 end of study participation

Upon completion of the study, the patient will undergo a final assessment. This includes a review of overall health and any long-term effects of the treatment.

Who Can Join the Study?

  • Must be 18 years of age or older.
  • Must have been diagnosed with smoldering multiple myeloma (SMM) for 5 years or less with measurable disease. This means having certain levels of proteins in the blood or urine.
  • Must have bone marrow plasma cells (BMPCs) between 10% and less than 60%. BMPCs are a type of cell found in the bone marrow.
  • Must have at least 2 high-risk factors, such as:
    • Serum M protein of 2 g/dL or more.
    • BMPCs greater than 20%.
    • A specific protein ratio in the blood greater than 20.
  • Must have an ECOG performance status score of 0 or 1. This score measures how well a person can perform daily activities.
  • Must meet certain laboratory test results within specific ranges, such as:
    • Absolute neutrophil count of 1.0 x 10^9/L or more. Neutrophils are a type of white blood cell.
    • Platelet count of 75 x 10^9/L or more. Platelets help with blood clotting.
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels no more than 2.5 times the upper limit of normal. These are liver enzymes.
    • Total bilirubin no more than 1.5 times the upper limit of normal, except for certain conditions like Gilbert syndrome.
  • Must sign an informed consent form to show understanding and willingness to participate in the study.
  • Women who can have children must have a negative pregnancy test before starting the study and agree to use two methods of birth control or abstain from heterosexual intercourse during the study and for at least 5 months after the last dose of the study drug.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliero Universitaria Careggi Florence Italy
Oslo Universitetssykehus HF Oslo Norway
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari Bari Italy
University Hospital Maastricht Maastricht The Netherlands

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Poitiers Poitiers France
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
Azienda Sanitaria Locale Di Pescara Pescara Italy
Azienda Ospedaliera Papardo Messina Italy
Azienda Ospedaliera di Padova Padua Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Alexandra Hospital Athens Greece
St. Antonius Ziekenhuis Nieuwegein The Netherlands
IRCCS Ospedale Policlinico San Martino Genoa Italy
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Nice Nice France
Azienda Ospedaliero-Universitaria Maggiore Della Carita Novara Italy
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Atzidzt Onltdmouyir Pujz Gtlsllaf Xltko Bergamo Italy
Inqlmqyu Rixnjqwlg Pow Lj Srctys Dta Tcpadm Dtwf Aivquvd Ignu Szlbeb Meldola Italy
Hxjdtubm Udsfhhukwx Cwpaubb Hglvmrag Helsinki Finland
Evqiogy Urjhnajhkzae Mheprvf Cocosqi Rzrycgccd (fnbhtdt Mhs Rotterdam The Netherlands
Czwylt Hiswnoqtfwp Rjvryqqm Uknsimdifswqe Df Twwtw Tours France

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

Trial status

Country Status Recruitment Start
Finland Finland
Not recruiting
15.01.2024
France France
Not recruiting
15.01.2024
Greece Greece
Not recruiting
15.01.2024
Italy Italy
Not recruiting
15.01.2024
Norway Norway
Not recruiting
15.01.2024
The Netherlands The Netherlands
Not recruiting
15.01.2024

Trial locations

Elranatamab is a medication being studied for its effectiveness in treating patients with high-risk smoldering multiple myeloma, a type of blood cancer. This trial aims to see how well Elranatamab works in patients who have not received any previous treatment for this condition.

Investigated diseases:

Smoldering Multiple Myeloma – Smoldering multiple myeloma is a condition characterized by an abnormal increase in plasma cells in the bone marrow. These cells produce a protein that can be detected in the blood or urine. Unlike active multiple myeloma, smoldering multiple myeloma does not cause symptoms or organ damage. It is considered a precursor to multiple myeloma, with a risk of progression to the active form of the disease. The condition is monitored closely to detect any signs of progression.

Trial ID:
2023-505775-70-00
Protocol code:
EMN34
Trial Phase:
Therapeutic exploratory (Phase II)

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