Clinical trial · Observational
Post-authorisation Study of Biological Relapse in Patients With Multiple Myeloma
Post-authorisation Observational Registry to Assess the Clinical Impact of Initiating Anti-tumour Rescue Therapy in Patients With Multiple Myeloma (MM) in Asymptomatic Biological Relapse Compared to Initiating Treatment at the Time of Symptomatic Relapse.
NCT02394210CI-TRIAL-00053886EPA-MMBRterminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Bias in the study
Summary
Brief summary (as posted)
Post-authorisation prospective follow-up study to assess the clinical impact on time to progression (TTP) from the start of anti- multiple myeloma treatment at the onset of asymptomatic relapse/biological progression versus start of treatment at the time of symptomatic relapse.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Group 1
- description
- Patients in relapse/biological progression (under the criteria of the IMW (International Myeloma Workshop) Consensus Panel 1 not receiving treatment until clinical relapse.
- label
- Group 2
- description
- Patients in relapse/biological progression receiving anti-MM treatment at the time of relapse/biological progression): Patients in this group may receive conventional anti-myeloma treatment as per routine clinical practice at the participating site: 1. Upon relapse/biological progression, defined as per the criteria of the IMW (International Myeloma Workshop) Consensus Panel Panel1 Or 2. Upon a significant relapse of paraprotein, defined as: * Duplication of M-component in two consecutive readings taken ≤2 months apart; or * An increase in absolute levels of serum M-protein ≥1 g/dL or M-protein in urine at ≥500 mg/24h, or * Increase in light chain levels ≥20 mg/dL with an abnormal ratio in two consecutive readings taken ≤2 months apart), which suggests the presence of biological progression/relapse criteria, but without including any clinical details of those involved in clinical relapse.
Primary outcomes (1)
- measure
- Time to progression (TTP)
- timeFrame
- Up to 38 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or female, greater than or equal to 18 years of age patients with a diagnosis of Multiple Myeloma (MM) based on the international criteria. 2. Patients with a diagnosis of Multiple Myeloma who had not received more than two regimen therapies and who had achieved at least a Partial Response (PR) with the last anti- Multiple Myeloma treatment according the criteria of the IMW (International Myeloma Workshop) Consensus Panel 1, included before relapse/biological progression or with an asymptomatic relapse (without Calcium increase, Renal Impairment, Anemia and Bone Lesion (CRAB) symptoms) defined by a ≥25% increase on the lowest value obtained during remission, in any of the following: * Serum M-protein (absolute increase must be ≥05 g/dL) and/or * Urine M-component (absolute increase must be ≥ 200 Mg/24 hrs.), and/or * Only for patients without measurable components in serum and urine, a 25% increase on the lowest difference in Free light chain (FLC) ratios (absolute increase \>10 mg/dL) * In patients with unmeasurable M-protein in serum and urine, and unmeasurable FLC levels, a 25% increase in the percentage of plasma cells in bone marrow (the absolute percentage must be ≥10%) In any case, it is necessary to have an analysis (proteinogram and/or immunofixation) in the two months (+/- 15 days) prior to inclusion in which it can be documented that the patient was not in a situation of relapse or asymptomatic progression. Patients with an asymptomatic relapse/progression from a Complete Response (CR): * Reappearance of serum or urine M-protein by immunofixation or electrophoresis 3. Patients who consent in writing after they has clearly explained the nature and purpose of the study (consent written informed). Exclusion Criteria: 1. Patients who are participating in an interventional clinical trial. 2. Patients that refuse to participate in the study. 3. Patients who present physical or mental incapacity to understand the information that is supplied, and/or respond to questions their doctor will perform as part of the study. 4. Clinical Relapse Criteria
References
Publications (0)
Data not yet available
No reference posted for this study.