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Completed

NCT Number: NCT02467010

Relapse Myeloma; Cyclofosfamide; Bortezomib; Maintenance

Bortezomib and cyclophosphamide in combination with dexamethasone has already demonstrated high response rates in refractory multiple myeloma. Low dose continuous cyclophosphamide, also called metronomic scheduling, minimize toxic side effects and eliminate the obligatory rest periods. Combining cyclophosphamide with bortezomib might target distinct aspects of a myeloma functionality.

The objectives of the present study are whether patients with refractory or relapsed multiple myeloma after reinduction with bortezomib, cyclophosphamide and dexamethasone will benefit from maintenance therapy with bortezomib and cyclophosphamide with acceptable side-effects. Recently two studies have shown with thalidomide that maintenance therapy might improve EFS and one study also the OS.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Medical Center Groningen

Groningen, Provincie Groningen, 9713 GZ, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • Stage II-III Multiple Myeloma
  • Relapse or primary refractory disease after initial chemotherapy
  • WHO performance status 0 - 2
  • Life expectancy of at least 6 weeks
  • ANC (absolute neutrophil count) ≥ 1.0x109/l(or ≥ 0.5x109/l, if due to bone marrow infiltration by malignancy)
  • Platelet count ≥ 75x109/l or ≥ 50x109/l, if due to bone marrow infiltration by malignancy)
  • Written informed consent (present in patient's file)
  • Patient is able and willing to use adequate contraception during therapy and for at least 1 month after study
  • Patient has the ability to understand the requirements of the study

Exclusion criteria

  • Previous treatment with bortezomib
  • Urine production < 1.5 l/24h
  • Pre-existent polyneuropathy (grade 2 or higher, according to CTCAE 3.0)
  • Pregnancy or positive pregnancy tests during study and for 1 month after final dose of thalidomide
  • History of active malignancy during the past 5 years with the exception of basal carcinoma of the skin)
  • Active uncontrolled infections
  • Additional uncontrolled serious medical or psychiatric illness

Treatment and study plan

bortezomib

Drug

Re-induction chemotherapy with bortezomib, cyclophosphamide and dexamethasone. All patients with first relapse or primary refractory multiple myeloma and bortezomib naive will be given 6 cycles of re-induction therapy. Patients will be evaluated for response after cycle 3 and 6.

Maintenance therapy with bortezomib and cyclophosphamide Maintenance therapy with bortezomib and cyclophosphamide will start at 4 weeks after the last cycle of re-induction chemotherapy if ANC ≥ 2.0 x 109/l and platelets > 75 x 109/l. Bortezomib is administered once every other week and cyclophosphamide (50 mg) every day for 1 year or until progression or death of any cause.

Other names: Velcade

Cyclophosphamide

Drug

Re-induction chemotherapy with bortezomib, cyclophosphamide and dexamethasone. All patients with first relapse or primary refractory multiple myeloma and bortezomib naive will be given 6 cycles of re-induction therapy. Patients will be evaluated for response after cycle 3 and 6.

Maintenance therapy with bortezomib and cyclophosphamide Maintenance therapy with bortezomib and cyclophosphamide will start at 4 weeks after the last cycle of re-induction chemotherapy if ANC ≥ 2.0 x 109/l and platelets > 75 x 109/l. Bortezomib is administered once every other week and cyclophosphamide (50 mg) every day for 1 year or until progression or death of any cause.

Other names: Endoxan

Dexamethasone

Drug

Re-induction chemotherapy with bortezomib, cyclophosphamide and dexamethasone. All patients with first relapse or primary refractory multiple myeloma and bortezomib naive will be given 6 cycles of re-induction therapy. Patients will be evaluated for response after cycle 3 and 6.

Maintenance therapy with bortezomib and cyclophosphamide Maintenance therapy with bortezomib and cyclophosphamide will start at 4 weeks after the last cycle of re-induction chemotherapy if ANC ≥ 2.0 x 109/l and platelets > 75 x 109/l. Bortezomib is administered once every other week and cyclophosphamide (50 mg) every day for 1 year or until progression or death of any cause.

Primary outcomes

  1. Toxicity of induction chemotherapy according to CTCAE version 3.0

    Time frame: 5 years

Secondary outcomes

  1. Progression Free Survival

    Time frame: 5 years

  2. Overall Survival

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

Bortezomib in Combination With Continuous Low-dose Oral Cyclophosphamide and Dexamethason Followed by Maintenance in Primary Refractory or Relapsed Bortezomib naïve Multiple Myeloma Patients. A Prospective Phase II Study.

Acronym: REMM

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Jun 9, 2015
Registry last updated
Jun 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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