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