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Hematologic MalignanciesPhase 1/2EMN-alloRICNCT01460420

Sequential Trial on Reduced Intensity Conditioning (RIC) Allogeneic Transplantation

A Phase 1/2 study testing Bz (Bortezomib) and Len (lenalidomide) in people with Hematologic Malignancies and Multiple Myeloma, run by European Myeloma Network B.V. at 10 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of the current study is to improve the outcome of patients with hematologic malignancies (in a phase I trial) and more specifically multiple myeloma (in a phase II trial) by 2 interventions: reduce the risk of graft-versus-host disease (GVHD) and improve the efficacy of the procedure decreasing the risk of… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hematologic Malignancies, Multiple Myeloma
What is being tested?
Bz (Bortezomib) and Len (lenalidomide)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
10 sitesin 4 countries
Study dates
Nov 2011to 29 Jun 2017
Phase
Phase 1/2
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

  • Phase I: For the first 10 patients:
  • Patients with any haematological malignancy in > CR1 (first complete remission)
  • Suitable related donor human leukocyte antigen (HLA)identical
  • Age > 18 and < 70 years
  • For the 10 subsequent patients:
  • Patients with any haematological malignancy candidates to receive an allogeneic transplant
Show all 17Show fewer
  • Suitable related or unrelated donor (a maximum of 1 mismatched is allowed)
  • Age > 18 and < 70 years phase II trial:
  • High-risk multiple myeloma patients at first relapse / second complete remission candidates to receive an allogeneic transplantation
  • Age:> 18 < 70 years.
  • Suitable donor, related or unrelated (a maximum of 1 mismatched is allowed)
  • Measurable disease
  • High risk first relapse is defined as:
  • First early relapse after Autologous Stem Cell Transplant (ASCT)< 24 months
  • First late relapses in case the patient does not achieve CR after second ASCT
  • First relapse in patients with poor cytogenetic features
  • All subjects must be able to comply with the Lenalidomide Pregnancy Prevention Risk Management Plan.

Who cannot join

  • Any of the following:
  • Prior severe comorbidity such as:
  • Heart failure or previous infarction
  • Uncontrolled Hypertension
  • Arrhythmia
  • Cirrhosis
Show all 17Show fewer
  • Peripheral neuropathy >Grade 2, 14 days prior to inclusion
  • Psychiatric disease
  • Prior history of other neoplasia except for carcinoma in situ in the last 10 years
  • Hypersensitivity to Bz, Boric acid mannitol.
  • Patients unable to use appropriate contraceptive methods
  • Patients who have received an investigational drug 30 days prior to inclusion
  • Positive human immunodeficiency virus (HIV) or active viral hepatitis
  • Patients with pericardial disease
  • Patients with acute diffuse infiltrative pulmonary disease
  • Patients not willing to comply with the Lenalidomide Pregnancy Prevention Risk Management Plan
  • Patients not willing to receive thromboprophylaxis during the consolidation phase will not be eligible.

Trial locations and contacts

10 sites in 4 countries.

10 sites in 4 countries

Spain6 sites

  • Hospital Clinic i Provincial,

    Barcelona

  • Hospital Santa Creu I Sant Pau,

    Barcelona

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Hospital Gregorio Marañón,

    Madrid

  • Hospital Clinico Universitario Salamanca,

    Salamanca

  • Hospital Universitario Virgen del Rocío,

    Seville

Other trials in Spain

Italy2 sites

  • S Giovanni Battista Hospital

    Torino

  • Azienda Ospedaliera Universitaria di Udine

    Udine

Other trials in Italy

Germany1 site

  • Medizinische Klinik and Poliklinik II, University Hospital

    Würzburg

Other trials in Germany

Sweden1 site

  • Karolinska University Hospital, Huddinge

    Stockholm

Other trials in Sweden

About this study

Official title: European Myeloma Network Sequential Phase I / Phase II Trial on RIC Allogeneic Transplantation: an Optimized Program for High Risk Relapsed Patients

The aim of the current study is to improve the outcome of patients with hematologic malignancies (in a phase I trial) and more specifically multiple myeloma (in a phase II trial) by 2 interventions: reduce the risk of graft-versus-host disease (GVHD) and improve the efficacy of the procedure decreasing the risk of relapses after transplant.

Currently, the standard approach used in most centers to prevent graft-versus-host disease after allogeneic transplantation is based on the combination of a calcineurin inhibitor (cyclosporine or tacrolimus) plus a short course of methotrexate. Unfortunately, this strategy is far from ideal, since the risk of acute GVHD is in the range of 30-40% among patients receiving a matched related donor transplantation and even higher among patients receiving transplantation from an unrelated donor while the incidence of chronic GVHD is 60-70% among patients receiving peripheral blood progenitor cells from either a related or unrelated donor.

Read more

As far as the patients with multiple myeloma (MM) is concerned, although the development of new drugs has markedly changed the outcome and management of these patients, allogeneic transplantation so far appears to be the only curative option, especially among those patients relapsing after first line treatment. Nevertheless, still new strategies within the allogeneic transplant setting are needed to improve its results.

Relapses may occur either extramedullary (very common in this setting) or systemic. In order to reduce the risk of systemic relapses the investigators will use maintenance therapy with Lenalidomide (Len) which, together with bortezomib (Bz) should contribute to eradicate minimal residual disease (MRD). In case the patient do not obtain complete remission or near complete remission after transplant, in addition to the maintenance therapy, the investigators will use four intensification cycles with VRD (Bz-Len-Dexamethasone).

In summary, the goal is to optimize the efficacy of allogeneic transplantation by two interventions: one focused on reducing the risk of relapse and the other on reducing the incidence of GVHD.

Being tested
Bz (Bortezomib), Len (lenalidomide)
Keywords
Allogeneic transplantation, Hematologic malignancies, Multiple myeloma, RIC (Reduced Intensity Conditioning)
Medical subject headings
Hematologic Neoplasms, Multiple Myeloma

What participants receive

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

  • Bz (Bortezomib)Drug

    Also called Codenamed PS-341, Marketed as Velcade

    Bz 1.3 mg/m2 on days +1, +4 and +7. Maintenance therapy and dose reduction pre-specified.

  • Len (lenalidomide)Drug

    Also called Rapamycin, CC-5013, Marketed as Revlimid

    Len at a dose of 6 mg po on day -5 and then 4 mg per day in order to maintain serum levels in the range of 6-12 ng /mL.

    Maintenance therapy and dose reduction pre-specified.

Study groups in NCT01460420
Study groupRoleWhat they receive
Bortezomib + LenalidomideExperimentalAfter conditioning treatment and graft versus host disease prophylaxis with Bz 1.3 mg/m2 on days +1, +4 and +7 plus sirolimus/rapamycin at a dose of 6 mg po on day -5 and then 4 mg per day in order to maintain serum levels in the range of 6-12 ng /mL, a maintenance therapy with Bz 1.3 mg/m2 on days 1, 8 and 15 in cycles of 56 days up to 6 cycles post-transplant and on day +180 Len will be started at a dose of 5 mg and will be maintained until relapse.
Receives: Drug: Bz (Bortezomib); Drug: Len (lenalidomide)

What is being measured

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

  1. Phase I trial: Safety of Len + Bz in patients with hematologic malignancies Phase II trial: Safety and efficacy of an optimized strategy of allogeneic transplantation in multiple myeloma undergoing allogeneic transplantation.

    For phase I trial: safety of Len + Bz. The phase I trial safety criteria will be evaluated in terms of (1) engraftment defined as > 500 granulocytes / microL and > 20.000 platelets / microL x 3 consecutive days will be required for 9/10 patients, (2) incidence of neuropathy grades 3-4 attributed to Bz > 20% (3) incidence of gastrointestinal toxicity attributed to Bz > 20%.

    For phase II trial: safety evaluated through adverse events and toxicity and efficacy evaluated as reduction of relapse rate as defined by the EBMT criteria.

    Measured: Up to one year after transplant

Secondary outcomes (5)

  1. Incidence of GVHD with this combination (phase I and II)

    Evaluation of a novel combination of Bz plus Len to prevent GVHD after allogeneic transplantation in patients with haematologic malignancies/MM

    Measured: Up to one year after transplant

  2. Phase II: response and relapse rate of this approach

    Reduction of relapse rate as defined by the EBMT (European Group for Blood, and Marrow Transplant)criteria.

    Measured: Up to one year after transplant

  3. Phase II: safety of the procedure

    For all patients safety will be assessed by the reporting of adverse events starting with the first study-related procedure and up to 30 days after the treatment period. The severity of adverse events will be assessed using National Cancer Institute (NCI) common toxicity criteria (CTC).

    Measured: Up to one year after transplant

  4. Evaluate the efficacy on survival

    Evaluate the efficacy of the procedure in terms of event free and overall survival

    Measured: Up to one year after transplant

  5. Efficacy of positron emission tomography (PET scan)and local radiotherapy

    Analyze the prognostic value and efficacy of imaging studies using PET scan and local radiotherapy in involved fields prior to or after (> 100 days) conditioning

    Measured: Up to one year after transplant

Timeline

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

  1. First posted26 Oct 2011 (estimated)
  2. Study startNov 2011
  3. Primary completionJun 2017
  4. Study completion29 Jun 2017

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
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01460420
Sponsor's protocol ID
EMN-alloRIC2010
Acronym
EMN-alloRIC
Status last verified
Jul 2017
First submitted
22 Sep 2011
Last updated
6 Jul 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Bz (Bortezomib) and Len (lenalidomide) in people with Hematologic Malignancies and Multiple Myeloma, run by European Myeloma Network B.V. at 10 sites in 4 countries.

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 17 inclusion and 17 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: finished, as of the sponsor's last update on 6 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Spain, Italy, Germany, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Phase I trial: Safety of Len + Bz in patients with hematologic malignancies Phase II trial: Safety and efficacy of an optimized strategy of allogeneic transplantation in multiple myeloma undergoing allogeneic transplantation. (time frame: Up to one year after transplant). 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 NCT01460420.

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 6 Jul 2017.

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