ASCT With Nivolumab in Patients With Multiple Myeloma

St. Petersburg State Pavlov Medical University30 enrolled

Overview

This is an open-label, single center trial of Autologous Stem Cell Transplantation (ASCT) with nivolumab in multiple myeloma patients to determine the efficacy and safety of ASCT and PD1 inhibitor combination. For this purpose, 30 multiple myeloma patients, who have received induction therapy and have achieved a partial response (PR), stable disease (SD) or progression, and thus have unfavorable prognosis, will be treated with nivolumab administered iv at a dose of 100 mg on days 3 before and 17 after high-dose melphalan with autologous stem cell transplantation.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Multiple Myeloma

Interventions

MelphalanDRUG

iv infusion 70-100 mg/m2 on day -3, -2

NivolumabDRUG

iv infusion 100 mg on day -3, +17

Autologous Stem Cell TransplantationPROCEDURE

peripheral blood stem cell transfusion at day 0

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects with MM (Multiple Myeloma) * Partial response, stable disease or progression after induction therapy (including ASCT) * Measurable disease * Successful peripheral blood stem cell collection with G-CSF * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2 * Signed informed consent * Patients after first-line induction therapy Exclusion Criteria: * Another malignancy requiring treatment at the time of inclusion * History of interstitial lung disease or pneumonitis * Patients with any other known concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes; cardiovascular disease including congestive heart failure NYHA Class III or IV, myocardial infarction within 6 months, and poorly controlled hypertension) which, in the opinion of the investigator could compromise participation in the study * Uncontrolled bacterial or fungal infection at the time of enrollment * Pregnancy * Somatic or psychiatric disorder making the patient unable to sign informed consent * Active or prior documented autoimmune disease requiring systemic treatment * Prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA4 therapy

Locations (1)

Boris V Afanasyev, MD, Prof.

Saint Petersburg, Russia

Outcomes

Primary Outcomes

Overall response

Includes complete response, very good partial response, and partial response (based on IMWG criteria)

Time frame: 3 months

Secondary Outcomes

Progression free survival (PFS)

PFS will be assessed with Kaplan-Meier method from the date of ASCT, with day 0 defined as date of stem cell infusion (in case of tandem transplant the 2nd of 2 transplants will be used) until the date of progression, defined as the date at which the patient starts the next line of therapy or the date of death.

Time frame: 12 months

Overall Survival (OS)

Will be assessed with Kaplan-Meier method from the date of ASCT, with day 0 defined as date of stem cell infusion (in case of tandem transplant the 2nd of 2 transplants will be used)

Time frame: 24 months

Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03

Toxicity parameters based on NCI CTCAE 4.03 grades: hematological toxicity (CBC), hepatotoxicity (liver function tests), nephrotoxicity (creatinine), neurotoxicity (attending physician assessment), fatigue (attending physician assessment), rash (attending physician assessment), colitis (attending physician assessment), pneumonitis (attending physician assessment), autoimmune disorders (level of hormones, presence of autoimmune antibodies, attending physician assessment).

Time frame: 12 months

Data from ClinicalTrials.gov

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