Monitoring of Deep of Response During Lenalidomide Maintenance in MM Patients Achieving at Least Very Good Partial Response (MRD)

NCT03433365 | Completed

• 1 other identifier: RV-MM-PI-0694
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This is an italian multicenter study to determine whether maintenance treatment with Lenalidomide-based regimen significantly increases the rate of molecular remission in patients achieving at least a VGPR after therapy with new drugs combination. No changing in the planned therapy will be made according to MRD results. A total of 70 patients with newly diagnosed MM who are 18 years of age or older and who meet all of the eligibility criteria may be enrolled in this study. Potential study subjects will sign an informed consent prior undergoing any study related procedure. Patients enrolled in this study will receive Lenalidomide-based regimen as maintenance therapy according to their previous decided therapeutic schedule. All consecutive patients treated with Lenalidomide-based regimen as maintenance therapy and with inclusion criteria will be asked to participate to this study. No additional drugs will be administrated for this study whose aim is to monitor the MRD on bone marrow aspirate and peripheral blood of patients during maintenance therapy with Lenalidomide-based regimen.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (3)

• MRD conversion

  Rate of conversion from MRD positive to MRD negative during maintenance therapy (qualitative PCR approach)

  2 years

• Tumour load

  Rate of patients with a reducing or increasing tumour load during therapy (quantitative real time PCR approach)

  2 years

• Molecular relapse

  Rate of molecular relapse

  2 years

Secondary Outcomes (4)

• MRD negativity

  2 years

• Molecular relapse

  2 years

• Peripheral blood compared with bone marrow

  2 years

• Overall Survival

  2 years

Study Arms (1)

1

Potential study subjects will sign an informed consent prior undergoing any study related procedure. Patients enrolled in this study will receive Lenalidomide-based regimen as maintenance therapy according to their previous decided therapeutic schedule. All consecutive patients treated with Lenalidomide-based regimen as maintenance therapy and with inclusion criteria will be asked to participate to this study.

Other: MRD analysis

Interventions

MRD analysis OTHER

To collect 2 samples for MRD analysis in patients treated with Lenalidomide

Also known as: No intervention_Observational study

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Potential study subjects will sign an informed consent prior undergoing any study related procedure. Patients enrolled in this study will receive Lenalidomide-based regimen as maintenance therapy according to their previous decided therapeutic schedule.

You may qualify if:

• Patient is, in the investigator(s) opinion, willing and able to comply with the protocol requirements.
• Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
• Patient has achieved at least a Very Good Partial Response (VGPR) before starting maintenance therapy
• Availability of a bone marrow sample at diagnosis stored in the Institution tissue bank to create patient-specific probes derived from IgH rearrangement
• Patients must receive Lenalidomide-based regimen as maintenance after a first line therapeutic approach
• Patient is 18 years old at the time of signing the informed consent
• Patient has a Karnofsky performance status ≥ 60%.
• Patient has a life-expectancy \> 6 months
• Patient has HBV, HCV and HIV negative test.
• Patients must have normal ECG and NYHA ≤ 2; an evaluation of ejection fraction by ECHO or MUGA is optional
• Patients must be informed on acute and late toxicity of Lenalidomide treatment and must sign an informed consent.

You may not qualify if:

• Any serious medical condition, including the presence of laboratory abnormalities, which places the subject at an unacceptable risk if he or she participates in this study or confounds the experimental ability to interpret data from the study.
• Achieving of a PR or less before starting maintenance therapy
• Pregnant or lactating women. A serum β-hCG pregnancy test must be performed at the Screening visit, for female patients of child-bearing potential. If the test is positive, the patient must be excluded from the study. Confirmation that the patient is not pregnant must be established by a negative serum or urinary pregnancy test with the result obtained 1 day prior to the Baseline visit (or the day of the visit if results are available before drug delivery). A pregnancy test is not required for naturally post-menopausal women (who have not had menses at any time in the preceding 24 consecutive months) or surgically sterilised women (hysterectomy, bilateral ovariectomy, bilateral salpingectomy).

Sponsors & Collaborators

• Fondazione EMN Italy Onlus: lead

Study Sites (1)

AOU Città della Salute e della Scienza di Torino

Torino, 10126, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

MRD determination will be performed using the tumor specific IgH rearrangement through allele specific real time PCR (ASO PCR). This technique is sensitive enough to detect one myeloma cells out of 105-106 normal cells and allows to perform quantitative evaluation too. This method for molecular MRD determination has already been published and in our laboratory has already been used for MRD analysis in MM. 2720 Thermal cyclers (Applied Biosystems, Carlsbad, California, USA) and the AbiPrism 7900HT (Applied Biosystems, Carlsbad, California, USA) will be employed to analyze MRD using qualitative and quantitative PCR approach. Both nested qualitative and real time quantitative PCR will be employed in this study.

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: February 14, 2018
• Study Start: March 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: August 1, 2017
• Last Updated: November 6, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)