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Evaluating characteristics and outcomes of patients with smoldering multiple myeloma

Smoldering Pathway Assessment Real-World Knowledge (SPARK) Study-Retrospective Observational, Non-interventional Chart Review Study in Smoldering Multiple Myeloma

Janssen-Cilag Ltd. · NCT06472778

This study looks at the characteristics and outcomes of people with smoldering multiple myeloma to see how many might progress to full-blown multiple myeloma and what happens to them.

Quick facts

Study typeObservational
Enrollment450 (estimated)
Ages18 Years and up
SexAll
SponsorJanssen-Cilag Ltd. (industry)
Locations29 sites (Chambray Les Tours and 28 other locations)
Trial IDNCT06472778 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the real-world characteristics and outcomes of participants diagnosed with smoldering multiple myeloma (SMM). It will categorize participants based on high-risk and non-high-risk criteria using established models such as the AQUILA study criteria and the IMWG 2020 risk classification. The study will also evaluate the risk of progression from SMM to multiple myeloma (MM) and analyze outcomes for those who progress to MM.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals with a documented diagnosis of smoldering multiple myeloma meeting specific clinical criteria.

Not a fit: Patients who do not have a diagnosis of smoldering multiple myeloma or who meet the SLiM-CRAB criteria for multiple myeloma will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the progression of smoldering multiple myeloma, potentially leading to improved management strategies for patients.

How similar studies have performed: Other studies have explored similar characteristics of smoldering multiple myeloma, but this specific observational approach may provide novel insights into real-world outcomes.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Have a documented diagnosis of smoldering multiple myeloma (SMM). SMM is defined as: (a) Clonal bone marrow plasma cells (BMPCs) greater than or equal to (\>=) 10 percent (%) and/or serum M-protein \>= 3 grams per deciliter (g/dL) and/or urine M-protein \>= 500 milligram per 24 hours (mg/24hrs). (b) Absence of SLiM-CRAB criteria: \>= 60 % clonal BMPCs, involved/uninvolved free light chain (FLC) ratio \>= 100 and involved FLC \>= 10 and magnetic resonance imaging (MRI) lesions; calcium elevation, renal insufficiency, anemia, and bone lesions (AB) criteria
* Informed consent obtained prior to retrospective data collection in accordance with local requirements, either an informed consent form (ICF) indicating that the participants signed a consent for data collection for this research and agrees to have their data collected and analyzed, with source data verification (SDV), or the country does accept the ICF waiver for such type of studies
* Data recorded in participants' medical charts from date of SMM diagnosis and at least 2 years after should be available in the participant's medical chart at the participating site. However, participants who died within the 2 years from SMM diagnosis are eligible

Exclusion Criteria:

* Therapy for multiple myeloma (MM) initiated within 90 days of SMM diagnosis
* Date of SMM diagnosis is missing
* Participants who have participated/are participating in any SMM interventional (either active treatment or control arm) study are not eligible. Participation in observational studies is allowed. Participants who have participated/are participating in any MM study after evolution to MM are eligible

Where this trial is running

Chambray Les Tours and 28 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Smoldering Multiple Myeloma

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.