Post-authorisation Study of Biological Relapse in Patients With Multiple Myeloma

• Register: ClinicalTrials.gov
• Last refreshed on: 20 September 2021
• Main ID: NCT02394210
• Date of registration: 16/03/2015
• Prospective Registration: No
• Primary sponsor: Celgene
• Public title: Post-authorisation Study of Biological Relapse in Patients With Multiple Myeloma EPA-MMBR
• Scientific title: 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.
• Date of first enrolment: May 14, 2013
• Target sample size: 415
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02394210
• Study type: Observational

Countries of recruitment

Spain

Contacts

• Name: Mireya Navarro, MD
• Affiliation: Celgene

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Myeloma

Primary Outcome(s)

Time to progression (TTP) [Time Frame: Up to 38 months]

Secondary Outcome(s)

Define the abnormal finding in complete blood count at base line [Time Frame: Baseline visit]

Age of participants at Baseline [Time Frame: Baseline visit]

Define the abnormal findings within the Biochemistry panel [Time Frame: Baseline visit]

Overall survival (OS) [Time Frame: Up to 38 months]

Adverse Events (AEs) [Time Frame: Up to 38 months]

Cost associated with participants visit to hospital/primary health care associated with anti-myeloma therapy [Time Frame: Up to 38 months]

ECOG performance status [Time Frame: Baseline visit]

Progression-free survival (PFS) [Time Frame: Up to 38 months]

EORTC QLQ-C30 Questionnaire [Time Frame: Up to 38 months]

Concomitant treatments related to MM [Time Frame: Baseline visit]

Overall Response rate [Time Frame: Up to 38 months]

Stage of Multiple Myeloma (MM) before study entry based on the international staging system (ISS) [Time Frame: Baseline visit]

QLQ-MY24 Questionnaire [Time Frame: Up to 38 months]

The time from biological progression until clinical relapse [Time Frame: Up to 38 months]

Event-free survival (EFS) [Time Frame: Up to 38 months]

Gender of participants at Baseline [Time Frame: Baseline visit]

Race of participants at Baseline [Time Frame: Baseline visit]

The number of Comorbidities [Time Frame: Baseline visit]

Time from first pathologic diagnosis [Time Frame: Baseline visit]

Secondary ID(s)

CEL-MIE-2012-02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors