Clinical Research Details

Descriptive Information
Study: prospective observational study of patients newly diagnosed with Multiple Myeloma with severe renal failure eligible for transplant.

Ali Ibrahim



  • Not sponsered
Conditions and Keywords
Age ≤ 66 years,newly diagnosed multiple myeloma,(eGFR) <40mL / min / 1.73m ²,severe renal insufficiency ,Patient with at least partial remission of the MM after induction,Absence of amyloidosis
Multiple Myeloma,Severe Renal insufficiency,eGFR less than 40
Study Design
Eligibility and IRB
Min: 0
Max: 66

Multiple myeloma (MM) is a malignant monoclonal plasma cell invasion of the bone marrow. The treatment of myeloma has considerably improved with the advent of new targeted therapies. Despite advances in targeted therapy, autologous hematopoietic stem cell transplantation (ASCT) remains the main standard of care in most patients.

In patients aged less than 66 years with intact renal function, ASCT as first line when compared to conventional chemotherapy demonstrated a complete response rate and overall and progression free survival advantage. However, there is no consensus on ASCT as first line therapy in patients with severe renal disease. ASCT for patients with renal comorbidities is carried out in multiple centers in France. The data from these centers was retrospectively compiled by the French Society of Registry of Marrow and Cell Therapy (SFGM-TC) and showed that ASCT for myeloma patients with renal comorbidities is feasible. Our non-interventional, prospective observational study will collect data on outcomes of patients with renal comorbidities after induction in order to further confirm the feasibility of ASCT for these patients.

The main objective of this study will be to evaluate Non Relapse Mortality (NRM) at D + 100 from the date of inclusion.

The treating physician will inform the patient about the study at the end of induction. If the patient is interested the research fellow will meet with the patient in private and explain the study. if the patient is interested he will sign the informed consent. Data on treatments administered before and after inclusion will be collected.

There are no risks to subjects except risk of breaching confidentiality, which will be minimal because all data will be de-identified, and stored in a password protected excel sheet and a locked cabinet accessible to the principle investigator and the study coordinator.  When sharing data it will be also de-identified, in a locked sheet with the password to the sheet sent in a separate email. 

The treating physician will identify the eligible subjects, he will inform them about the study during their clinic visit. If the patient is interested he will meet with the research fellow who will explain the details of the study in a private setting. If the patient agrees to enroll he will sign the consent and will be added to the study

Patients aged less than 66 years diagnosed with multiple myeloma 

- Age ≤ 66 years

 - Confirmed diagnosis of newly diagnosed multiple myeloma

- severe renal insufficiency (estimated Glomerular Filtration Rate (eGFR) <40mL / min / 1.73m ²)

 - Patient with at least partial remission of the MM after induction.

 - Absence of amyloidosis

- Able to give informed consent

Patient who has not achieved at least a partial response after induction

- A history of another malignancy

- Pregnant or lactating woman