Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03315026
Recruitment Status : Recruiting
First Posted : October 19, 2017
Last Update Posted : May 7, 2019
Sponsor:
Collaborator:
Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
Autologous stem cell transplant is beneficial to patients who are diagnosed with multiple myeloma or systemic amyloidosis. However, undesired symptoms such as weakness, fatigue, nausea, pain and sleep disturbance after transplant can contribute to complications and increase the how long the patient is in the hospital, especially in patients age 60-75. Research has shown that the development and the intensity of these symptoms are closely associated with an increase in a protein called a cytokine which is involved in the inflammatory response in the human body. One of the cytokines is called Interleukin-6 or IL-6.Therefore, this study will investigate if blocking IL-6 with an agent called siltuximab, administered before and after transplant, will decrease the symptom burden after transplant to improve quality of life and recovery in the immediate post-transplant period.

Condition or disease Intervention/treatment Phase
Multiple Myeloma AL Amyloidosis Drug: Siltuximab Behavioral: The M.D. Anderson Symptom Inventory (MDASI) Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This is a phase II study investigating the symptomatic and cytokine response to an anti-IL-6 chimeric monoclonal antibody (siltuximab) during the acute phase of autologous stem cell transplantation (ASCT) in older individuals with multiple myeloma (MM) and systemic AL amyloidosis (AL).
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : December 14, 2017
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020


Arm Intervention/treatment
Experimental: Siltuximab
Siltuximab 11mg/kg will be administered seven days before and 21 days after autologous stem cell infusion (+/-2 day).
Drug: Siltuximab
Siltuximab at 11mg/kg will be administered as a 1-hour infusion on day -7 and day +21 (+/-2) after stem cell infusion.

Behavioral: The M.D. Anderson Symptom Inventory (MDASI)
assessments will be conducted at baseline (day -10 +/-3), day -2 (+/-1), , day +7 (+/-1 ), and day 30 (+/-3).




Primary Outcome Measures :
  1. number of patients with improved symptoms [ Time Frame: 30 days post ASCT ]
    as assessed by the MD Anderson symptom inventory Multiple Myeloma Module (MDASI-MM)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 (β-human chorionic gonadotropin [β-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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03315026


Contacts
Layout table for location contacts
Contact: Gunjan Shah, MD, MS 212-639-8356 shahg@mskcc.org
Contact: Sergio Giralt, MD 212-639-3859

Locations
Layout table for location information
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Gunjan Shah, MD, MS    212-639-8356      
Principal Investigator: Gunjan Shah, MD,MS         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Janssen Scientific Affairs, LLC
Investigators
Layout table for investigator information
Principal Investigator: Gunjan Shah Memorial Sloan Kettering Cancer Center

Additional Information:
Layout table for additonal information
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03315026     History of Changes
Other Study ID Numbers: 17-365
First Posted: October 19, 2017    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Memorial Sloan Kettering Cancer Center:
Siltuximab
Autologous Stem Cell Transplantation (AST)
17-365

Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Myeloma
Neoplasms, Plasma Cell
Amyloidosis
Immunoglobulin Light-chain Amyloidosis
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Proteostasis Deficiencies
Metabolic Diseases
Siltuximab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs