The REMNANT (RElapse from Mrd Negativity As iNdication for Treatment) study

Phase 1

• Conditions: Multiple myeloma; MedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-004401-27-NO
• Lead Sponsor: Oslo University Hospital, Department of Hematology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-16
• Last Update Posted: 19 February 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 391

Inclusion Criteria

Part 1:
•Patients must be >18 and < 75 years of age
•Newly diagnosed with multiple myeloma (IMWG guidelines) eligible for ASCT
•ECOG performance status score 0, 1 or 2. ECOG 3 can be enrolled if caused by myeloma.
•Written informed consent
Part 2:
Patients must be CR and MRD negative measured by Euroflow NGF after first line therapy
Patients included directly into part 2 must have a MRD negative test which is less than one month old from time of testing after consolidation to screening for part 2.
Patients must be >18 years
Has completed first line treatment during Part 1 of this study (Norwegian sites)
Has received 1.L treatment according to local guidelines (other sites)
Must have measurable disease at diagnosis
ECOG performance status score 0, 1 or 2

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 391
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Part 1:
•Received more than one cycle of induction treatment for multiple myeloma.
•Not able to comply with the study protocol
•Any other prior or ongoing disease/health conditions incompatible with the study procedures
•An active malignancy with lower expected survival than myeloma.

Part 2:
•An active malignancy with a lower life expectancy than myeloma
•Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
* Refractory to daratumumab and/or carfilzomib

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified