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


Phase 1/Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Hematologic Malignancies, Multiple Myeloma

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Trial Information

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


Inclusion Criteria:



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

- 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.

Exclusion Criteria:

Any of the following:

- Prior severe comorbidity such as:

- Heart failure or previous infarction

- Uncontrolled Hypertension

- Arrhythmia

- Cirrhosis

- 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Outcome Description:

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.

Outcome Time Frame:

Up to one year after transplant

Safety Issue:

Yes

Principal Investigator

Jose-Antonio Perez-Simon, MD-PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital Virgen del Rocio

Authority:

Spain: Spanish Agency of Medicines

Study ID:

EMN-alloRIC2010

NCT ID:

NCT01460420

Start Date:

November 2011

Completion Date:

November 2015

Related Keywords:

  • Hematologic Malignancies
  • Multiple Myeloma
  • Allogeneic transplantation
  • Hematologic malignancies
  • Multiple myeloma
  • RIC (Reduced Intensity Conditioning)
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Hematologic Neoplasms

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