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Maintenance Therapy With Subcutaneous Bortezomib

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ClinicalTrials.gov Identifier: NCT01913730
Recruitment Status : Active, not recruiting
First Posted : August 1, 2013
Last Update Posted : August 3, 2018
Sponsor:
Collaborator:
Fondazione Neoplasie Sangue Onlus
Information provided by (Responsible Party):
Stichting Hemato-Oncologie voor Volwassenen Nederland

Brief Summary:
This is a multicenter, randomized, open label study designed to evaluate the efficacy and safety of prolonged treatment with bortezomib twice monthly and dexamethasone after a salvage treatment containing bortezomib for relapsed or refractory multiple myeloma patients.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Bortezomib Drug: Dexamethasone Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A PHASE II MULTI-CENTRE, RANDOMIZED, OPEN LABEL STUDY OF MAINTENANCE THERAPY WITH SUBCUTANEOUS BORTEZOMIB TWICE MONTHLY ASSOCIATED WITH DEXAMETHASONE, IN RELAPSED AND REFRACTORY MULTIPLE MYELOMA PATIENTS AFTER SALVAGE WITH BORTEZOMIB-BASED THERAPY
Actual Study Start Date : November 2013
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : November 2020


Arm Intervention/treatment
No Intervention: No prolonged therapy is scheduled
Experimental: Bortezomib Dexamethasone (Biochemical relapse)
Patients randomized in this group will be observed. At the occurrence of biochemical relapse, 4 VD cycles will be administered: Bortezomib (SC) and Dexamethasone (PO) weekly.
Drug: Bortezomib
Drug: Dexamethasone



Primary Outcome Measures :
  1. Time to Progression [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Survival [ Time Frame: 5 years ]
    Overall Survival Progression Free Survival

  2. Response [ Time Frame: 5 years ]
    Objective overall response rate (ORR)

  3. Response [ Time Frame: 5 years ]
    Duration of response

  4. Response [ Time Frame: 5 years ]
    Time to response

  5. Response [ Time Frame: 5 years ]
    Time to the next anti-myeloma therapy (TNT)

  6. Response [ Time Frame: 5 years ]
    TTP measured from the beginning of the salvage treatment

  7. Response [ Time Frame: 5 years ]
    Role of the type of salvage treatment

  8. Response [ Time Frame: 5 years ]
    Role of previous treatments

  9. Response [ Time Frame: 5 years ]
    Incidence of grade 3 and 4 hematological and non-hematological adverse events (AEs)

  10. Response [ Time Frame: 5 years ]
    Exploratory assessment on prognosis (ISS, age and FISH abnormalities)



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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:

  1. Patient is of a legally consenting age as defined by local regulations.
  2. Patient is, in the investigator(s) opinion willing and able to comply with the protocol requirements.
  3. Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
  4. Female patient is either post-menopausal for 24 consecutive months or surgically sterilised or agree to continuous abstinence from heterosexual sexual contact or willing to use two acceptable method of birth control at the same time (one highly effective method and one additional effective method) (Highly Effective Methods: Intrauterine device -IUD-; Hormonal -birth control pills, injections, implants-; tubal ligation; partner's vasectomy; Additional Effective Methods: Latex condom; Diaphragm; Cervical Cap) for 4 weeks prior to beginning study drug therapy, during study drug therapy (including dose interruption) and for 4 weeks after discontinuation of therapy.
  5. Male patient agrees to use an acceptable method for contraception (i.e., condom or abstinence) during study drug therapy (including dose interruption) and for 4 weeks after discontinuation of bortezomib therapy.
  6. Patient was previously diagnosed with multiple myeloma based on standard criteria.
  7. Patient is relapsed or refractory after one to three lines of treatment and the last one must be a bortezomib-containing regimen, without evidence of progressive disease.
  8. Patient had previously received at least 4 cycles of a salvage treatment containing bortezomib, before enrolment, without evidence of progressive disease.
  9. Patient must be enrolled and start therapy within 45 days from the completion of the last salvage cycle containing Bortezomib.
  10. Before the salvage treatment with bortezomib-based regimens, patient must have measurable disease

Exclusion Criteria:

  1. Any serious medical condition, laboratory abnormality or psychiatric illness that prevented the subject from signing the informed consent form or placed the subjects at unacceptable risk.
  2. Pregnant or lactating females
  3. Known positive for HIV or active infectious hepatitis type A, B or C
  4. Peripheral neuropathy or neuropathic pain grade 2 or higher, as defined by National Cancer Institute Common Toxicity Criteria (NCI CTC) 4.0
  5. Infiltrative pulmonary disease.

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): NCT01913730


Locations
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Italy
Irccs Crob
Rionero in Vulture, Potenza, Italy
Sponsors and Collaborators
Stichting Hemato-Oncologie voor Volwassenen Nederland
Fondazione Neoplasie Sangue Onlus

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Responsible Party: Stichting Hemato-Oncologie voor Volwassenen Nederland
ClinicalTrials.gov Identifier: NCT01913730     History of Changes
Other Study ID Numbers: 26866138-MMY-2084
First Posted: August 1, 2013    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018

Keywords provided by Stichting Hemato-Oncologie voor Volwassenen Nederland:
Multiple Myeloma
Refractory
Relapsed

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
Dexamethasone
Dexamethasone acetate
Bortezomib
BB 1101
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
Protease Inhibitors