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Compares treatment options for Multiple Myeloma
Official title Study Comparing Therapy for Advanced Relapsed/Refractory Multiple Myeloma With and Without Dexamethasone
ClinicalTrials.gov ID: NCT06561854
What this study is testing
What is Dexamethasone?
Dexamethasone is an investigational medicine, given as an once-weekly, being studied as a potential treatment for multiple myeloma.
Also referred to as Neofordex.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Patients with relapsed/refractory symptomatic multiple myeloma who meet all inclusion criteria, will be randomized 1:1 to receive either standard of care chemotherapy (IKEMA or ICARIA) and dexamethasone until disease progression ("dexamethasone arm", arm A) or standard of care chemotherapy (IKEMA or ICARIA) and dexamethasone with dexamethasone discontinuation from the 3rd cycle of treatment (after 8 weeks) ("dexamethasone-free arm", arm B). In most centers, IKEMA and ICARIA schema can be adapted according to the standard of care in each center Choice between the ICARIA and IKEMA schema is at the discretion of the investigator, in compliance with each drug's SmPC, but must be performed before randomisation for the purpose of stratification.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult patients (≥18 years old)
- Documented MM in relapse according to standard criteria.
- 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...
- Eligible for one of the following antibody-based approved combinations:
- ICARIA schema: isatuximab, pomalidomide and dexamethasone.
You likely can't join if
- Contraindications to investigational medicinal products or auxiliary medicinal product
- Evidence of refractoriness or intolerance to anti-CD38 monoclonal antibodies.
- Previous treatment according to the ICARIA schema with pomalidomide or IKEMA schema with carfilzomib
- Allogenic hematopoietic cell transplant (HCT, regardless of timing).
- Planned to undergo an hematopoietic cell transplant prior to progression of disease ie, these patients should not be enrolled in order to reduce...
- History of malignancy (other than MM) within 3 years before the date of randomization (exceptions are squamous and basal cell carcinomas of the skin...
See the full eligibility criteria
- Adult patients (≥18 years old)
- Documented MM in relapse according to standard criteria.
- 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:
- ICARIA schema: isatuximab, pomalidomide and dexamethasone.
- IKEMA schema: isatuximab, carfilzomib and dexamethasone
- Subject must have achieved a response (PR or better) to the prior regimen.
- ECOG Performance Status score of 0, 1, or 2.
- For people experiencing toxicities resulting from previous therapy (including peripheral neuropathy), the toxicities must have been resolved or stabilized.
- Signed informed consent
- Contraindications to investigational medicinal products or auxiliary medicinal product
- Evidence of refractoriness or intolerance to anti-CD38 monoclonal antibodies.
- Previous treatment according to the ICARIA schema with pomalidomide or IKEMA schema with carfilzomib
- Allogenic hematopoietic cell transplant (HCT, regardless of timing).
- 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.
- 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...
- Known MM meningeal Involvement.
- 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...
- 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...
- Uncontrolled chronic obstructive pulmonary disease (COPD)
- Clinically significant cardiac disease.
- Seropositive for hepatitis B with positive PCR
- Seropositive for human immunodeficiency virus (HIV) or hepatitis C
- Lactation
- Participation to another treatment clinical trial
- Inability to give written informed consent
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.