Comparing treatments for advanced multiple myeloma with and without dexamethasone
Free Regimen of Dexamethasone as Initial Therapy for Advanced Relapsed/Refractory Multiple Myeloma: an Open-label Randomized, Non-inferiority, Controlled Trial
This study is testing whether stopping dexamethasone after the first cycle of chemotherapy helps people with advanced multiple myeloma feel better compared to continuing it until their disease gets worse.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 318 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Drugs / interventions | isatuximab, chemotherapy |
| Locations | 1 site (Paris) |
| Trial ID | NCT06561854 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with documented relapsed or refractory multiple myeloma who have received 1 to 3 prior therapies.
Not a fit: Patients who have contraindications to the investigational drugs or have shown refractoriness to anti-CD38 monoclonal antibodies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with advanced multiple myeloma, potentially reducing side effects associated with prolonged dexamethasone use.
How similar studies have performed: Other studies have shown promising results with similar treatment approaches, indicating that this trial builds on existing knowledge in the field.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Paris
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.