Siltuximab to Decrease Symptom Burden After Autologous Stem Cell Transplantation for Patients With Multiple Myeloma and AL Amyloidosis

• Register: ClinicalTrials.gov
• Last refreshed on: 13 November 2023
• Main ID: NCT03315026
• Date of registration: 13/10/2017
• Prospective Registration: Yes
• Primary sponsor: Memorial Sloan Kettering Cancer Center
• Public title: Siltuximab to Decrease Symptom Burden After Autologous Stem Cell Transplantation for Patients With Multiple Myeloma and AL Amyloidosis
• Scientific title: Phase II Study of Interleukin 6 Blockade With Siltuximab to Decrease Symptom Burden in Patients Age 60-75 Undergoing Autologous Stem Cell Transplantation for Multiple Myeloma and AL Amyloidosis
• Date of first enrolment: December 14, 2017
• Target sample size: 30
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03315026
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Gunjan Shah
• Affiliation: Memorial Sloan Kettering Cancer Center

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with histologically-confirmed symptomatic multiple myeloma or AL amyloidosis
undergoing autologous HCT with melphalan 140 or 200 mg/m2

- Age 60 through 75 years

- Have at least 3 million x 10e6 CD34+ cells/kg to be infused

- Diffusion capacity >45% (adjusted for hemoglobin) as predicted by pulmonary function
testing.

- KPS performance status = 60% or ECOG Performance Status score of 0-2

- Clinical laboratory values meeting the following criteria within 4 weeks before
enrollment:

- LVEF >45% by MUGA or rest ECHO

- Diffusion capacity >45% (adjusted for hemoglobin) as predicted pulmonary function
testing

- Platelet count = 20 x 10^9/L

- ALT and AST = 2.5 x ULN

- Total bilirubin = 2.5 x ULN; except if the elevation is due to Gilbert's syndrome

- Calculated creatinine clearance > 40 mL/min

- Before enrollment, all women are expected to be not of childbearing potential as they
will be age 60-75>:

- Not of childbearing potential: postmenopausal (>45 years of age with amenorrhea
for at least 12 months or any age with amenorrhea for at least 6 months and a
serum follicle stimulating hormone (FSH) level >40 IU/mL); permanently sterilized
(eg, tubal occlusion, hysterectomy, bilateral salpingectomy); or otherwise be
incapable of pregnancy

- Of childbearing potential and practicing (during the study and for 3 months after
receiving the last dose of study agent) a highly effective method of birth
control consistent with local regulations regarding the use of birth control
methods for subjects participating in clinical studies: eg, established use of
oral, injected or implanted hormonal methods of contraception; placement of an
intrauterine device (IUD) or intrauterine system (IUS); barrier methods: condom
with spermicidal foam/gel/film/cream/suppository or occlusive cap (diaphragm or
cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; male
partner sterilization (the vasectomized partner should be the sole partner for
that subject); true abstinence (when this is in line with the preferred and usual
lifestyle of the subject)

- A woman of childbearing potential must have a negative serum (ß-human chorionic
gonadotropin [ß-hCG]) pregnancy test at screening

- During the study and for 3 months after receiving the last dose of study agent, a
woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted
reproduction

- Note: If the childbearing potential changes after start of the study (eg, woman
who is not heterosexually active becomes active) a woman must begin a highly
effective method of birth control, as described above.

- A man who is sexually active with a woman of childbearing potential and has not had a
vasectomy must agree to use a barrier method of birth control eg, either condom with
spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm
or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men
must also not donate sperm during the study and for 3 months after receiving the last
dose of study drug

Exclusion Criteria:

- Prior exposure to agents targeting IL-6 or the IL-6 receptor

- Other malignancy within the past 2 years, except for the following if treated and not
active: basal cell or nonmetastatic squamous cell carcinoma of the skin, cervical
carcinoma in situ or International Federation of Gynecology and Obstetrics (FIGO)
Stage 1 carcinoma of the cervix

- Concurrent medical condition or disease (eg, autoimmune disease, active systemic
Infection) that is likely to interfere with study procedures or results, or that in
the opinion of the investigator would constitute a hazard for participating in the
study

- Vaccination with live attenuated vaccines within 4 weeks of first study agent
administration

- Clinically significant infection, including known HIV or hepatitis C infection, or
known hepatitis B (Hep B) surface antigen positivity. Patients with Hep B Core
positivity can be enrolled if the Hep B PCR is negative, and they are on antiviral
suppression.

- Received an investigational drug (including investigational vaccines) or used an
invasive investigational medical device within 14 days or 5 half lives before
enrollment or is currently enrolled in the treatment stage of an investigational study

- Had hospitalization for infection or major surgery (eg, requiring general anesthesia)
within 2 weeks before enrollment or have not fully recovered from surgery. Note:
subjects with surgical procedures conducted under local anesthesia may participate

- A woman who is pregnant or breast-feeding, or a woman who is planning to become
pregnant or a man who plans to father a child while enrolled in this study or within 3
months after the last dose of study agent.



Age minimum: 60 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Myeloma

AL Amyloidosis

Intervention(s)

Behavioral: The M.D. Anderson Symptom Inventory (MDASI)

Drug: Siltuximab

Primary Outcome(s)

number of patients with improved symptoms [Time Frame: 30 days post ASCT]

Secondary ID(s)

17-365

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Janssen Scientific Affairs, LLC