Protocoles de recherche clinique

Les différentes études cliniques sur le myélome multiple ouvertes au recrutement l’Hôpital Maisonneuve-Rosemont sont présenté sur cette page. Ces études présentées excluent les études à venir et les études en cours, mais fermées au recrutement. L’affichage de ces différentes études cliniques se veut un outil pour favoriser la participation des patients aux études cliniques. Encore une fois, l’amélioration du pronostic des patients atteints d’un myélome multiple n’est pas le fruit du hasard, mais bien le résultat de la recherche, dont la participation des patients à la recherche clinique!

(en anglais seulement)

Première ligne: éligible à la greffe

A phase II, open-label study of Bortezomib following nonmyeloablative allogeneic stem cell transplant in patients with high-risk multiple myeloma HMR-MM-001

(Étude de phase II évaluant l’impact du Bortezomib administré chaque 2 semaines pour 1 an, après une allogreffe non myéloablative de cellules souches hématopoïétiques chez des patients avec myélome multiple à mauvais risque)
Infirmière de recherche Nathalie Lachapelle 514-252-3400 poste 4471

Inclusion Criteria :

  • Age 18 to 65 years, inclusively.
  • Newly diagnosed multiple myeloma patients (based on IMWG criteria) with measurable disease at diagnosis, based on presence of any of the following:
    • Serum intact immunoglobulin ≥ 10 g/L;
    • Bence-Jones proteinuria ≥ 200 mg/day;
    • Serum free light chain (sFLC) assay ≥ 100 mg/L (difference between involved and uninvolved FLC levels) and an abnormal sFLC ratio.
  • High-risk patients presenting any of the following:
    • ISS III;
    • del(17p13), t(4;14) with ISS II or III, t(14;16), t(14;20) and chromosome 1 abnormalities by FISH;
      • At this time, there is no international consensus on the threshold to consider these cytogenetic abnormalities as significant. For this study, we will consider arbitrarily a percentage ≥ 10% as significant.
    • PCL, defined as an absolute blood plasma cell count > 2×109/L and the presence of > 20% plasma cells among peripheral blood white cells;
    • Patients ≤ 50 years, regardless of cytogenetics or ISS stage.
  • Having received a Bortezomib-containing regimen (VTD, CyBorD, VRD or PAD [in patients with PCL]) for a minimum of 4 cycles with ≥ partial response.
  • Received high-dose Melphalan ≥ 140 mg/m2 followed by autologous stem cell transplantation.
  • Available HLA-identical sibling donor or 8/8 allele matched (HLA-A, -B, -C, -DR) MUD.

Exclusion Criteria

  • Failure to achieve at least a partial response with a Bortezomib-based induction therapy.
  • Progressive disease any time before NMA allogeneic transplant.
  • Having received tandem autologous stem cell transplantation.
  • Having received maintenance or consolidation therapy with Bortezomib after ASCT.
    • However, one common characteristic of high-risk myeloma is short duration of response and early relapse after standard treatment. If delays to allogeneic transplant are expected because of complications or donor assessment, Lenalidomide at 10 mg die for a maximum of three months will be allowed after ASCT (initiated after day +90) and discontinued at least 14 days before the start of the conditioning regimen.
  • Karnofsky score < 70% or comorbidity index HCT-CI > 3.
  • Bilirubin > 2 x upper limit of normal (ULN) unless felt to be related to Gilbert’s disease or hemolysis; AST and ALT > 2.5 x ULN; alkaline phosphatase > 5 x ULN.
  • Peripheral neuropathies or neuropathic pain ≥ grade II.
  • Poor organ function defined as either:
    • Diffusing capacity of the lung for carbon monoxide corrected for hemoglobin using Dinakara method (DLCOc) < 50%; forced expiratory volume in 1 second < 50%; forced vital capacity < 50%;
    • Left ventricular ejection fraction (LVEF) < 40% evaluated by echocardiogram or multi-gated acquisition scan (MUGA); uncontrolled arrhythmia; symptomatic cardiac disease;
    • Creatinine clearance < 60 mL/minute;
    • Liver cirrhosis.
  • Patients with non secretory disease or non measurable disease in serum or urine at time of diagnosis.
  • Known hypersensitivity to boron, mannitol or Bortezomib.
  • Active infection with any of the following viruses: HIV, HTLV-1 or 2, hepatitis B (defined as HBsAg positivity) or hepatitis C (defined as anti-HCV positivity or HCV-RNA positivity).
  • Presence of another malignancy with an expected survival estimated < 75% at 5 years (complete resection of basal cell carcinoma or squamous cell carcinoma, complete resection of a ductal carcinoma in situ, presence of lobular carcinoma in situ, complete resection of carcinoma in situ of the cervix, or an in situ or low-risk prostate cancer after curative therapy are not exclusion criteria).
  • Positive beta-human chorionic gonadotropin (β-hCG) pregnancy test, to be performed in all women of childbearing potential at screening and baseline. Female study participants who are surgically sterile (hysterectomy) or who have been postmenopausal for at least 12 consecutive months are automatically eligible for this criterion.
  • Study participants not agreeing to remain abstinent or to practice double-barrier forms of birth control from trial screening through 90 days from the last dose of Bortezomib.
  • Women who are lactating.
  • Women of childbearing potential who are planning to become pregnant while enrolled in this study up to 30 days after the last Bortezomib injection.
  • Participation in a trial with an investigational agent within 30 days prior to entry in the study.
  • Inability to provide written informed consent prior to initiation of any study-related procedures, and inability, in the opinion of investigators, to comply with all requirements of the study.
  • Estimated probability to survive less than 6 months after allogeneic transplant.
  • Suspicion of cardiac amyloidosis.
  • Current history of drug and/or alcohol abuse.
  • Any abnormal condition or laboratory result that is considered by investigators capableof altering patient’s condition, compliance or study outcome.
  • Any patient who, in the opinion of investigators, should not participate in this study.

Première ligne: non éligible à la greffe.

Aucune étude ouverte au recrutement pour le moment.

Myélome multiple récidivant et/ou réfractaire:  SVP communiquez avec nous.

 

Autres types d’études dont évaluation des traitements de support

Aucune étude ouverte au recrutement pour le moment.

Référence de patients

Pour référer un patient à l’Hôpital Maisonneuve-Rosemont pour une étude clinique, veuillez communiquer avec Mme Nathalie Lachapelle, infirmière et coordonnatrice de recherche au   514-252-3400, poste 4471 ou par courriel au: nlachapelle.hmr@ssss.gouv.qc.ca

 

Pour des études sur le myélome multiple dans d’autres centres au Québec, veuillez vous référer au site du GEOQ.