Actively Recruiting

Phase 2
Age: 60Years +
All Genders
NCT06679829

A Study of Melphalan With or Without Siltuximab in People With Multiple Myeloma Having an Autologous Stem Cell Transplant

Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-24

215

Participants Needed

7

Research Sites

155 weeks

Total Duration

On this page

Sponsors

M

Memorial Sloan Kettering Cancer Center

Lead Sponsor

R

RECORDATI GROUP

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this study is to see if siltuximab plus population pharmacokinetic (PK)-dosed melphalan works as well as the usual approach (body surface area \[BSA\]-dosed melphalan) in people with multiple myeloma (MM) who are receiving an autologous stem cell transplant (ASCT) as part of their standard treatment. The researchers will also see if siltuximab in combination with population PK-dosed melphalan works to decrease symptoms after an ASCT, and will study the safety of siltuximab. For the run-in, 15 patients will receive siltuximab, 11 mg/kg, seven days before and 14 days after autologous hematopoietic stem cell infusion (+/-2 day).

CONDITIONS

Official Title

A Study of Melphalan With or Without Siltuximab in People With Multiple Myeloma Having an Autologous Stem Cell Transplant

Who Can Participate

Age: 60Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically-confirmed symptomatic multiple myeloma
  • Undergoing autologous hematopoietic stem cell transplant within 12 months of diagnosis
  • Age 60 years or older
  • At least 3 million CD34+ cells/kg to be infused
  • Karnofsky Performance Status >60% or ECOG Performance Status 0-2
  • Pulmonary diffusion capacity >45% within 6 weeks prior to enrollment
  • Left ventricular ejection fraction >45% within 6 weeks prior to enrollment
  • Platelet count ≥ 20 x 10^9/L
  • ALT and AST ≤ 2.5 times upper limit of normal
  • Total bilirubin ≤ 2.5 times upper limit of normal unless due to Gilbert's syndrome
  • Calculated creatinine clearance > 40 mL/min
  • Women must be not of childbearing potential
  • Men sexually active with women of childbearing potential must agree to use barrier contraception and not donate sperm during and for 3 months after the study
Not Eligible

You will not qualify if you...

  • Prior treatment with agents targeting IL-6 or IL-6 receptor
  • Other malignancy within past 2 years except treated and inactive basal cell or nonmetastatic squamous cell skin cancer, cervical carcinoma in situ, or FIGO Stage 1 cervical carcinoma
  • Concurrent medical conditions likely to interfere with study or pose hazard
  • Ischemic heart disease requiring intervention within 3 months, uncontrolled heart failure, or uncontrolled arrhythmia
  • QTc interval >460ms (or >500ms with bundle branch block)
  • Live attenuated vaccine within 4 weeks before first study drug
  • Clinically significant infection including known HIV or hepatitis B surface antigen positivity
  • Recent investigational drug or device use within 14 days or 5 half-lives
  • Hospitalization for infection or major surgery within 2 weeks before enrollment or incomplete recovery
  • Men planning to father a child during study or within 3 months after last dose

AI-Screening

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Trial Site Locations

Total: 7 locations

1

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States, 07920

Actively Recruiting

2

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States, 07748

Actively Recruiting

3

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States, 07645

Actively Recruiting

4

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Commack, New York, United States, 11725

Actively Recruiting

5

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States, 10604

Actively Recruiting

6

Memorial Sloan Kettering Cancer Center (All protocol activities)

New York, New York, United States, 10065

Actively Recruiting

7

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States, 11553

Actively Recruiting

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Research Team

G

Gunjan Shah, MD

CONTACT

H

Heather Landau, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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