AzTrials
AzTrials

Multiple MyelomaEarly Phase 1NCT02447055

Allogeneic Stem Cell Transplantation for Patients With Multiple Myeloma

A Early Phase 1 study testing Tocilizumab, Melphalan and Fludarabine in people with Multiple Myeloma and Myeloma-Multiple, run by Washington University School of Medicine.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

The purpose of this study is to develop a novel platform for allo-SCT in multiple myeloma (MM) with the idea of maximizing anti-myeloma effect with conditioning and minimizing GvHD (graft versus host disease). Specifically, the investigators will use the Flu/Mel (fludarabine and melphalan) regimen. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Multiple Myeloma, Myeloma-Multiple
What is being tested?
Tocilizumab, Melphalan and Fludarabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Dec 2015to Jun 2016
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed diagnosis of myeloma.
  • Between 18 and 70 years of age (inclusive).
  • Karnofsky performance status ≥ 50% or ECOG performance score of ≤ 2 -Completion of last anti-myeloma therapy (if any) must occur at least 14 days before conditioning.
  • Must have an HLA-matched sibling, HLA-matched unrelated donor, or a related haploidentical donor:
  • Available HLA-matched sibling or unrelated donor must meet the following criteria:
  • At least 18 years of age
Show all 29Show fewer
  • HLA donor/recipient match based on at least low-resolution typing per institutional standards (syngeneic donors [identical twins] are excluded)
  • In the investigator's opinion, is in general good health, and medically able to tolerate leukapheresis required for harvesting stem cells
  • No active hepatitis
  • Negative for HTLV and HIV
  • Not pregnant
  • OR
  • Available haploidentical donor must meet the following criteria:
  • Blood-related family member (sibling (full or half), offspring, parent, cousin, niece or nephew, aunt or uncle, or grandparent)
  • At least 18 years of age
  • HLA-haploidentical donor/recipient match by at least low-resolution typing per institutional standards
  • In the investigator's opinion, is in general good health, and medically able to tolerate leukapheresis required for harvesting stem cells
  • No active hepatitis
  • Negative for HTLV and HIV
  • Not pregnant
  • Normal bone marrow and organ function as defined below within 14 days prior to first study drug dose (conditioning regimen):
  • Total bilirubin ≤ 2.5 mg/dl
  • AST (SGOT) and ALT (SGPT) ≤ 2.5 x ULN
  • Creatinine ≤ 2.0 x ULN OR estimated creatinine clearance ≥ 30 mL/min/1.73 m2 by Cockcroft-Gault Formula (See Appendix C)
  • Oxygen saturation ≥ 90% on room air
  • LVEF ≥ 40%
  • FEV1 and FVC ≥ 40% predicted, DLCOc ≥ 40% predicted
  • Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry through Day +100 visit. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
  • Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Who cannot join

  • Receiving renal replacement therapy, hemodialysis, or peritoneal dialysis.
  • Presence of another concurrent malignancy requiring treatment.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to melphalan, cyclophosphamide, or other agents used in the study.
  • Presence of an uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant and/or breastfeeding.
  • Previous treatment with tocilizumab (TCZ).
Show all 18Show fewer
  • Immunization with a live/attenuated vaccine within 28 days prior to conditioning.
  • Any history of recent serious bacterial, viral, fungal, or other opportunistic infections, precluding a stem cell transplant according to the treating physician.
  • Serologic evidence of HIV
  • Active infection with Hepatitis A, B, or C. Active infection is defined as serologic positivity and elevated liver function tests.
  • History of tuberculosis
  • Active infection with EBV as defined as EBV viral load ≥ 10,000 copies per mL of whole blood; EBV viral load testing is only required if the patient has clinical signs or symptoms suggestive of active EBV infection
  • Active infection with CMV as defined as CMV viral load ≥ 10,000 copies per mL of whole blood; CMV viral load testing is only required if the patient has clinical signs or symptoms suggestive of active CMV infection
  • History of complicated diverticulitis, including fistulae, abscess formation or gastrointestinal (GI) perforation.
  • Pre-existing CNS demyelination or seizure disorders
  • Major surgery within preceding 8 weeks
  • Body weight >150kg
  • History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies.

About this study

Official title: Allogeneic Stem Cell Transplantation for Patients With Multiple Myeloma: a Pilot Feasibility Study Using a Novel Protocol

The purpose of this study is to develop a novel platform for allo-SCT in multiple myeloma (MM) with the idea of maximizing anti-myeloma effect with conditioning and minimizing GvHD (graft versus host disease). Specifically, the investigators will use the Flu/Mel (fludarabine and melphalan) regimen. For GvHD prophylaxis, the investigators use the Hopkins PT-Cy (post-transplant cyclophosphamide) platform with the novelty of adding tocilizumab as both an anti-myeloma therapy and as a method to reduce GvHD. IL-6 has an important role in promoting the growth of myeloma cells and progression of disease.

Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02447055
Study groupRoleWhat they receive
Arm 1 (Flu/Mel/PT-Cy & Tac/MMF for certain cases)Experimental* Fludarabine 30 mg/m^2 intravenously (IV) on Days -5, -4, -3, and -2 * Melphalan 140 mg/m^2 IV on Day -2 * Tocilizumab 8 mg/m^2 (capped at 800 mg) IV on Day -1 * Stem cell infusion on Day 0 * Cyclophosphamide 50 mg/kg IV on Days +3 and +4 * Tacrolimus 1 mg/day IV on Day +5 (for unrelated \& haploidentical cases) * Mycophenolate mofetil 15 mg/kg orally three times per day on Day +5 (for unrelated \& haploidentical cases) * Filgrastim 10 ug/kg/day subcutaneously until neutrophil recovery starting on Day +5
Receives: Biological: Tocilizumab; Drug: Melphalan; Drug: Fludarabine; Drug: Cyclophosphamide; Drug: Tacrolimus; Drug: Mycophenolate mofetil; Drug: Filgrastim

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and tolerability of regimen as measured by grade and frequency of adverse events

    Adverse events will be graded using NCI CTCAE v4.0 and summarized by grade and frequency

    Measured: Day +100

Secondary outcomes (9)

  1. Cumulative incidence and severity of acute GvHD

    Measured: 6 months

  2. Cumulative incidence and severity of chronic GvHD

    Measured: 1 year

  3. Non-relapse mortality (NRM)

    -NRM is defined as death occurring in a patient from causes other than disease relapse or progression

    Measured: 1 year

  4. Non-relapse mortality (NRM)

    -NRM is defined as death occurring in a patient from causes other than disease relapse or progression

    Measured: Day +100

  5. Progression-free survival (PFS)

    -PFS is defined as the duration from transplant to time of first progression, death, relapse after CR, or the date the patient was last known to be in remission.

    Measured: 1 year

  6. Overall survival (OS)

    -OS is defined as the duration from the time of transplant to death or last follow-up.

    Measured: 1 year

  7. Time to neutrophil engraftment

    • Neutrophil engraftment is defined as ANC > 0.5 × 10^9/L × 3 consecutive daily assessments. The first of 3 consecutive days for which ANC > 0.5 × 10^9/L will be recorded as the date of neutrophil engraftment. Time to neutrophil engraftment will be calculated as the time from the date of the ASCT to the date of neutrophil engraftment.
    • Non-engraftment is defined as failure to reach an ANC > 0.5 × 10^9/L × 3 consecutive daily assessments by Day +30.

    Measured: Day +30

  8. Time to platelet engraftment

    • Platelet engraftment is defined as an untransfused platelet measurement > 20,000/ x10^9/L × 3 consecutive daily assessments. The first of 3 consecutive days for which the untransfused platelet measurement is > 20,000 x 10^9/L will be recorded as the date of platelet engraftment. Time to platelet engraftment will be calculated as the time from receiving the date of ASCT to the date of platelet engraftment. Untransfused is defined as no transfusions within 7 days.
    • Non-engraftment is defined as failure to reach platelets > 20,000 × 10^9/L × 3 consecutive assessments by Day +100.

    Measured: Day +100

  9. Non-relapse mortality (NRM)

    -NRM is defined as death occurring in a patient from causes other than disease relapse or progression

    Measured: Day +180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2015 (estimated)
  2. Study startDec 2015
  3. Primary completionJun 2016
  4. Study completionJun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02447055
Sponsor's protocol ID
201508102
Status last verified
Jul 2016
First submitted
13 May 2015
Last updated
12 Jul 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Tocilizumab, Melphalan and Fludarabine in people with Multiple Myeloma and Myeloma-Multiple, run by Washington University School of Medicine.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability of regimen as measured by grade and frequency of adverse events (time frame: Day +100). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02447055.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in