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Treatment with carfilzomib, lenalidomide and dexamethasone versus lenalidomide and dexamethasone in patients with high-risk smoldering Multiple Myeloma
EU CTIS ID: 2024-511334-12-00
What this study is testing
To assess MRD negativity rate by NGF after 9 cycles for all eligible ITT patients of KRd versus Rd in patients with high-risk SMM
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients must have histologically or cytologically confirmed Smoldering Multiple Myeloma based on the 2014 International Myeloma Working Group Criteria: Serum M-protein ≥3 g/dl or urinary monoclonal protein >500 mg per 24 hours and/or Absence of CRAB symptoms and myeloma defining events
- Written informed consent
- Calculated Creatinine Clearance ≥ 50 ml/min
- Patient is capable of giving informed consent
- Patients must have high risk Smoldering Multiple Myeloma based on the Mayo Clinic and/or the PETHEMA criteria
- Measurable disease
You likely can't join if
- Patients with symptomatic multiple myeloma (i.e. having myeloma defining events)
- Significant cardiovascular disease with NYHA grade III or IV symptoms, or hypertrophic cardiomegaly, or restrictive cardiomegaly, or myocardial infarction within 3 months prior to enrollment, or unstable angina, or unstable arrhythmia
- Active hepatitis B or C infection
- Known or suspected HIV infection
- Incidence of gastrointestinal disease that would prevent absorption
- Patients with gastric or duodenal ulcers
See the full eligibility criteria
- Patients must have histologically or cytologically confirmed Smoldering Multiple Myeloma based on the 2014 International Myeloma Working Group Criteria: Serum M-protein ≥3 g/dl or urinary monoclonal protein >500 mg per 24 hours and/or Absence of CRAB symptoms and myeloma defining events
- Written informed consent
- Calculated Creatinine Clearance ≥ 50 ml/min
- Patient is capable of giving informed consent
- Patients must have high risk Smoldering Multiple Myeloma based on the Mayo Clinic and/or the PETHEMA criteria
- Measurable disease
- Age >18 years
- WHO/ECOG performance status <=2
- Patients must have normal organ and marrow function
- Patients must be willing and capable to use adequate contraception during and after the therapy (all men, all premenopausal women) Patients must be able to adhere to the requirements of the Lenalidomide Pregnancy Prevention Plan
- Females of childbearing potential must have a negative serum or urine pregnancy test within 10 - 14 days prior to entry and again within 24 hours of starting lenalidomide treatment
- Patients with symptomatic multiple myeloma (i.e. having myeloma defining events)
- Significant cardiovascular disease with NYHA grade III or IV symptoms, or hypertrophic cardiomegaly, or restrictive cardiomegaly, or myocardial infarction within 3 months prior to enrollment, or unstable angina, or unstable arrhythmia
- Active hepatitis B or C infection
- Known or suspected HIV infection
- Incidence of gastrointestinal disease that would prevent absorption
- Patients with gastric or duodenal ulcers
- Significant neuropathy ≥Grade 3 or grade 2 with pain within 14 days of enrollment
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection.
- History of other malignancy (apart from basal cell carcinoma of the skin, or in situ cervix carcinoma) except if the patient has been free of symptoms and without active therapy during at least 5 years
- Major surgery within 1 month prior to enrollment
- Pre-existing pulmonary, cardiac or renal impairement that prevents hydration measures
- Amyloid Light-chain (AL) amyloidosis
- Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Patients who are receiving any other investigational agents.
- Concurrent systemic treatment or prior therapy within 4 weeks for SMM
- Contraindication to any concomitant medication, including antivirals, anticoagulation prophylaxis, tumor lysis prophylaxis, or hydration given prior to therapy
- History of allergic reactions attributed to immunomodulatory agents and proteasome inhibitors.
- Hypersensitive reaction to active substances or any excipients of the IMPs
- Uncontrolled hypertension or diabetes
- Pregnant or lactating females.
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.