A study of ixazomib plus lenalidomide plus dexamethasone (IRd) for newly diagnosed transplant-eligible myeloma patients

Phase 1

• Conditions: Multiple myeloma newly diagnosed transplant-eligible patients; MedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2015-004863-35-FI
• Lead Sponsor: Hospital District of Helsinki and Uusimaa/Helsinki University Hospital HUS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-17
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Newly diagnosed transplant eligible male or female multiple myeloma patients, 18-70 years of age, who have not received prior treatment for multiple myeloma. Symptomatic and measurable disease diagnosed by standard CRAB and SLIM-CRAB biomarker criteria. Voluntary informed consent. Negative pregnancy test.
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 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

Female patients who are lactating or pregnant. Major surgery or radiotherapy within 14 days before enrollment. Central nervous system involvement with myeloma. Active infection requiring systemic antibiotic therapy. Unablity to use thrombosis or herpes zoster prophylaxis or treatment. Grade 1 polyneuropathy with pain or worse.Plasma cell leukemia or amyloidosis. Patients who are not willing to adhere to the pregnant prevention program.

Study & Design

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