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Nelfinavir as Bortezomib-sensitizing Drug in Patients With Proteasome Inhibitor-nonresponsive Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02188537
Recruitment Status : Completed
First Posted : July 11, 2014
Last Update Posted : June 26, 2019
Sponsor:
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research

Brief Summary:

Trial objectives:

To decide whether the addition of nelfinavir to the approved antimyeloma therapy with bortezomib and dexamethasone has sufficient activity in proteasome inhibitor-resistant myeloma patients to merit further clinical investigation in a prospective controlled trial.

Additional research questions:

To collect myeloma cell samples from proteasome inhibitor-resistant myeloma patients for the assessment of the biology of proteasome inhibitor resistance and the identification of predictive markers for response to nelfinavir-based antimyeloma therapy.


Condition or disease Intervention/treatment Phase
Myeloma Drug: Nelfinavir Drug: bortezomib Drug: Dexamethasone Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nelfinavir as Bortezomib-sensitizing Drug in Patients With Proteasome Inhibitor-nonresponsive Myeloma. A Multicenter Phase II Trial
Actual Study Start Date : December 2, 2014
Actual Primary Completion Date : July 26, 2016
Actual Study Completion Date : April 17, 2018


Arm Intervention/treatment
Experimental: Nelfinavir, Bortezomib, Dexamethasone
The trial is designed as an "add-on" therapy, where nelfinavir is added to the approved bortezomib-containing therapy. Bortezomib and dexamethasone background treatment will be given in the Swissmedic-approved dose and schedule and according to international therapeutic standard.
Drug: Nelfinavir
Nelfinavir 2x 2500 mg p.o. days 1 - 14
Other Name: Viracept

Drug: bortezomib
Bortezomib 1.3 mg/m2 i.v. or s.c. days 1, 4, 8, 11
Other Name: Velcade®

Drug: Dexamethasone
Dexamethasone 20 mg p.o. days 1-2, 4-5, 8-9, 11-12




Primary Outcome Measures :
  1. Response rate based on best response observed during the trial [ Time Frame: end of cycle 6 (at week 19) ]

Secondary Outcome Measures :
  1. Adverse events [ Time Frame: end of cycle 6 (at week 19) ]
  2. Proportion of patients achieving at least a minor response [ Time Frame: end of cycle 6 (at week 19) ]
  3. Disease control rate (no evidence of disease progression for at least 3 cycles) [ Time Frame: end of cycle 6 (at week 19) ]
  4. Time from registration to the start of the next new antimyeloma therapy or death from any cause [ Time Frame: end of cycle 6 (at week 19) ]
  5. Progressive disease under trial treatment [ Time Frame: end of cycle 6 (at week 19) ]
  6. Quality of life [ Time Frame: day 1 of cycle 4 (week 10) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient must give written informed consent prior to any protocol-specific procedure.
  • Patient was diagnosed with multiple myeloma based on standard IMWG criteria, and has received at least one previous line of chemotherapy.
  • Patient has been exposed to or is intolerant to at least one IMID (thalidomide, lenalidomide, pomalidomide).
  • A therapy with bortezomib in the approved dose and schedule, based on Swissmedic approval (treatment of patients with relapsed/refractory multiple myeloma who have received at least one prior line of therapy), is indicated and intended.
  • Patient is refractory to his/her most recent proteasome inhibitor-containing regimen, based on divers criteria.
  • WHO performance status ≤ 3.
  • Age ≥ 18 years.
  • Adequate hematological values: platelets ≥ 50 x 109/L, hemoglobin ≥ 80 g/L (both may be achieved by transfusion).
  • Adequate hepatic function: bilirubin ≤ 1.5 x ULN (for patients with suspected hemolysis: direct bilirubin ≤ 1.5 x ULN), ALT ≤ 3 x ULN (≤ 5 x ULN if liver infiltration by myeloma suspected, based on imaging results).
  • Calculated creatinine clearance ≥ 15 mL/min, according to the formula of Cockcroft-Gault, see Appendix 1).
  • Women are not breastfeeding. Women with child-bearing potential are using effective contraception (see 9.8), are not pregnant and agree not to become pregnant during participation in the trial and during the 12 months thereafter. A negative pregnancy test before inclusion (within 7 days) into the trial is required for all women with child-bearing potential. Men agree not to father a child during participation in the trial and during 12 months thereafter.
  • Completed baseline QoL questionnaire.

Exclusion Criteria:

  • Evidence of ongoing uncontrolled systemic infections.
  • History of chronic active HCV or HBV.
  • Evidence of myeloma within the CNS.
  • Psychiatric disorder precluding understanding of information on trial related topics, giving informed consent, filling out quality of life (QoL) forms, or interfering with compliance for oral drug intake.
  • Exposure to another experimental drug within 3 weeks prior to trial entry.
  • Any serious underlying medical condition (at the judgment of the investigator) which may impair the ability of the patient to participate in the trial, in particular any uncontrolled clinically significant active disease (e.g. active autoimmune disease, uncontrolled diabetes, uncontrolled cardiac disease).
  • Non-hematologic active malignancy within the past 5 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the cervix or breast; c) prostate cancer of Gleason Grade 6 or less with stable prostate-specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder or benign tumors of the adrenal or pancreas.
  • Concomitant use of other anti-cancer medication or radiotherapy except for local pain control. The use of bisphosphonates is allowed.
  • Significant neuropathy (Grades 3-4, or Grade 2 with pain) within 14 days prior to enrollment.
  • Known hypersensitivity to bortezomib or nelfinavir or hypersensitivity to components of these drugs.
  • Any psychological, familial, sociological or geographical condition likely hampering compliance with the trial protocol and follow-up.
  • Patient who takes the following drugs during the trial therapy, which cannot be replaced or paused.

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): NCT02188537


Locations
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Switzerland
Kantonsspital Aarau
Aarau, Switzerland, CH-5001
Kantonsspital Baden
Baden, Switzerland, 5404
Universitaetsspital-Basel
Basel, Switzerland, CH-4031
Istituto Oncologico Svizzera Italiana IOSI
Bellinzona, Switzerland, 6500
Inselspital Bern
Bern, Switzerland, 3010
Kantonsspital Graubuenden
Chur, Switzerland, CH-7000
Hopital Fribourgeois
Fribourg, Switzerland, 1708
Hopital Cantonal Universitaire de Geneve
Geneva, Switzerland, CH-1211
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH-1011
Kantonsspital - St. Gallen
St. Gallen, Switzerland, CH-9007
SpitalSTS AG Simmental-Thun-Saanenland
Thun, Switzerland, 3600
UniversitätsSpital Zürich
Zürich, Switzerland, 8091
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
Investigators
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Study Chair: Christoph Driessen, Prof MD Cantonal Hospital of St. Gallen
Study Chair: Panagiotis Samaras, MD Universitätsspital Zürich
Publications of Results:
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Responsible Party: Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier: NCT02188537    
Other Study ID Numbers: SAKK 39/13 - FORTUNE
SNCTP000001061 ( Registry Identifier: SNCTP )
First Posted: July 11, 2014    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Swiss Group for Clinical Cancer Research:
Myeloma
proteasome inhibitor-nonresponsive myeloma
Nelfinavir
bortezomib
bortezomib-sensitizing drug
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Nelfinavir
Dexamethasone
Bortezomib
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
HIV Protease Inhibitors
Protease Inhibitors