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Trial record 1 of 2 for:    PETHEMA/GEM2012MENOS65
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Bortezomib (Velcade®), Lenalidomide (Revlimid®) and IV Busulfan (Busilvex®) in Patients Under 65 Years Old (GEM2012MENOS65)

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ClinicalTrials.gov Identifier: NCT01916252
Recruitment Status : Completed
First Posted : August 5, 2013
Last Update Posted : September 27, 2017
Janssen, LP
Pierre Fabre Medicament
Information provided by (Responsible Party):
PETHEMA Foundation

Brief Summary:

This protocol is a national, multicenter, comparative, open-label, randomized trial comparing the progression free survival (PFS) of two pre-transplant conditioning regimens (BUMEL versus. MEL-200).

A total of 460 patients will be enrolled in the study. Scheduled evaluations and study visits will take place during the pre-treatment, treatment and follow-up periods.

The pre-treatment period includes the screening visit in which participants provide informed consent in writing in order to take part in the study. The patient is then assessed to determine his/her eligibility. The selection process will begin 21 days before the first dose of medication is administered (days -21 to 0). During the treatment period, eligible patients will be included in the study and given six cycles of induction treatment with bortezomib/ lenalidomide / dexamethasone (VRD-GEM). Each cycle will last 28 days, during which SC bortezomib will be administered on days 1, 4, 8 and 11, oral lenalidomide on days 1-21 of each cycle, and oral dexamethasone on days 1-4 and 9-12 of the cycle.

After the first three induction cycles, and in the absence of progression or unacceptable toxicity, peripheral blood hematopoietic stem cells will be mobilized and collected using G-CSF for later autologous transplantation. Patients will be randomized in a 1:1 allocation ratio to receive conditioning treatment with MEL-200 versus BUMEL. Randomization will take place at the beginning of the study, once the screening is complete and the patient's eligibility verified. Three months after transplantation, patients will receive two cycles of consolidation treatment with VRD-GEM at the same doses administered during induction treatment.

Once the treatment phase is complete, patients will begin the follow-up phase in which they will be visited every three months to evaluate disease progression and survival

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: bortezomib (Velcade ®) Drug: lenalidomide (Revlimid®) Drug: busulfan (Busilvex ®) Drug: Dexamethasone acetate Drug: Melphalan Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 460 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, National, Open-label, Multicenter, Phase III Trial Studying Induction Therapy With Bortezomib/Lenalidomide/Dexamethasone (VRD-GEM), Followed by High-dose Chemotherapy With Melphalan-200 (MEL-200) Versus Busulfan-melphalan (BUMEL), and Consolidation With VRD-GEM in Patients Under 65 Years Old With Newly-diagnosed, Symptomatic Multiple Myeloma
Study Start Date : September 2013
Actual Primary Completion Date : November 16, 2016
Actual Study Completion Date : November 16, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Active Comparator: MEL-200
bortezomib/lenalidomide/dexamethasone (VRD-GEM) induction treatment followed by high-dose melphalan-200 (MEL-200)
Drug: bortezomib (Velcade ®)
Drug: lenalidomide (Revlimid®)
Drug: Dexamethasone acetate
Drug: Melphalan
Active Comparator: BUMEL
bortezomib/lenalidomide/dexamethasone (VRD-GEM) induction treatment followed by busulfan-melphalan (BUMEL) chemotherapy and consolidation with VRD-GEM
Drug: bortezomib (Velcade ®)
Drug: lenalidomide (Revlimid®)
Drug: busulfan (Busilvex ®)
Drug: Dexamethasone acetate
Drug: Melphalan

Primary Outcome Measures :
  1. Progression Free Survival to measure the treatment efficacy [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Complete response rates to measure the treatment efficacy [ Time Frame: 1 year ]
  2. Evaluation of minimal residual disease immunofixation negative-CR after each phase of treatment [ Time Frame: 1 year ]
  3. Overall survival [ Time Frame: Time to death ]
  4. Describe the adverse events to evaluate the safety and tolerability [ Time Frame: 4 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • The patient must, in the opinion of the investigator, be capable of complying with all requirements of the trial
  • Have signed the informed consent form
  • Be between 18 and 65 years of age and a candidate for autologous stem cell transplant
  • Have an ECOG Performance Status > 2 (or 3 if the ECOG is due to myeloma)
  • Newly diagnosed patient with symptomatic multiple myeloma based on standard criteria, who has not received any prior chemotherapy treatment for Multiple Myeloma.
  • Patient must have measurable disease, defined by the following criteria:

For secretory MM, measurable disease is defined by any quantifiable value of serum M-protein (IgG ≥ 10 g/L or IgA > 5 g/L) and/or, when applicable, an excretion of light chain in urine ≥ 200 mg/24 hours.

For oglio- or non-secretory multiple myeloma, measurable disease is defined by the presence of soft tissue (not bone) plasmacytomas, which is determined by clinical exam or radiographic techniques.

  • Life expectancy > 3 months.
  • The patient must have the following laboratory values in the 21 days prior to initiation of treatment (day 1, cycle 1):

Platelet count ≥ 100 x 109/L and absolute neutrophil count of ≥ 1.0 x 109/L Corrected serum calcium < 14 mg/dL. Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x the upper limit of normal (ULN).

Total bilirubin within normal limits. Serum creatinine ≤ 2 mg/dL

- Women of childbearing potential and men (including vasectomized men whose partners are women of childbearing potential), must use two methods of contraception during the entire course of treatment, during dose interruptions and for up to three months after receiving the final dose

Exclusion Criteria:

  • Non-secretory myeloma without measurable plasmacytomas.
  • Patients who have undergone prior treatment for multiple myeloma, with the exception of emergency treatment using steroid pulses, bisphosphonates, or radiotherapy received before beginning induction treatment.
  • Peripheral neuropathy ≥ grade 2 in the 21 days prior to inclusion.
  • Known hypersensitivity to bortezomib, boric acid, mannitol or lenalidomide.
  • Patients that have received any investigational agent in the 28 days prior to inclusion in the study.
  • Patients who have had a myocardial infarction in the six months prior to inclusion in this study or who are a class III or IV according to the New York Heart Association (NYHA) functional classification system, heart failure, unstable angina, uncontrolled ventricular arrhythmias or acute ischemia detected by electrocardiogram, or nervous system disorders.
  • Patients currently enrolled in another clinical trial or receiving any type of investigational agent.
  • Patients who are seropositive for HBV, HCV or HIV.

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): NCT01916252

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Sponsors and Collaborators
PETHEMA Foundation
Janssen, LP
Pierre Fabre Medicament
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: PETHEMA Foundation
ClinicalTrials.gov Identifier: NCT01916252    
Other Study ID Numbers: GEM2012MENOS65
First Posted: August 5, 2013    Key Record Dates
Last Update Posted: September 27, 2017
Last Verified: December 2016
Keywords provided by PETHEMA Foundation:
Multiple Myeloma
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists