Comparing treatments for advanced multiple myeloma with and without dexamethasone

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial involves adult patients with relapsed or refractory symptomatic multiple myeloma who will be randomized to receive either standard chemotherapy with dexamethasone until disease progression or a similar regimen with dexamethasone discontinued after the first cycle. The study aims to evaluate the efficacy and safety of these two approaches, utilizing established chemotherapy schemas (IKEMA or ICARIA) tailored to each patient's needs. Participants will be monitored for treatment response and side effects throughout the trial duration.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adult patients (≥18 years old)
2. Documented MM in relapse according to standard criteria.
3. All patients must have received between 1 to 3 prior therapies for MM (a prior therapy is defined as 2 or more cycles of therapy given as a MM treatment plan)

   * Eligible for one of the following antibody-based approved combinations:

     1. ICARIA schema: isatuximab, pomalidomide and dexamethasone.
     2. IKEMA schema: isatuximab, carfilzomib and dexamethasone
4. Subject must have achieved a response (PR or better) to the prior regimen.
5. ECOG Performance Status score of 0, 1, or 2.
6. For subjects experiencing toxicities resulting from previous therapy (including peripheral neuropathy), the toxicities must have been resolved or stabilized.
7. Signed informed consent

Exclusion Criteria:

1. Contraindications to investigational medicinal products or auxiliary medicinal product
2. Evidence of refractoriness or intolerance to anti-CD38 monoclonal antibodies.
3. Previous treatment according to the ICARIA schema with pomalidomide or IKEMA schema with carfilzomib
4. Allogenic hematopoietic cell transplant (HCT, regardless of timing).
5. Planned to undergo an hematopoietic cell transplant prior to progression of disease ie, these patients should not be enrolled in order to reduce disease burden prior to transplant.
6. History of malignancy (other than MM) within 3 years before the date of randomization (exceptions are squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix, or malignancy that in the opinion of the Investigator is considered cured with minimal risk of recurrence within 3 years).
7. Known MM meningeal Involvement.
8. Plasma cell leukemia (\>2.0 × 109/L circulating plasma cells by standard differential) or Waldenström's macroglobulinemia or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or amyloidosis.
9. Any concurrent medical condition or disease (e.g., active systemic infection) that is likely to interfere with study procedures or results, or that, in the opinion, of the Investigator would constitute a hazard by participating in this study.
10. Uncontrolled chronic obstructive pulmonary disease (COPD)
11. Clinically significant cardiac disease.
12. Seropositive for hepatitis B with positive PCR
13. Seropositive for human immunodeficiency virus (HIV) or hepatitis C
14. Lactation
15. Participation to another interventional clinical trial
16. Inability to give written informed consent

Where it's running

• Service d'hématologie clinique et thérapie cellulaire, Saint-Antoine Hospital
  Paris, France Recruiting

Study contacts

• Principal investigator: Mohamad MOHTY, PU-PH — Assistance Publique - Hôpitaux de Paris
• Study coordinator: Mohamad MOHTY, PU-PH
• Email: mohamad.mohty@inserm.fr
• Phone: + 33 1 49 28 26 20

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.