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Relapse Myeloma; Cyclofosfamide; Bortezomib; Maintenance (REMM)

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Bortezomib
Cyclophosphamide
Dexamethasone
Sponsored by
University Medical Center Groningen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Bortezomib, cyclophosphamide, dexamethason, multiple myeloma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Medical Center Groningen

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bortezomib, cyclophosphamide, dexamethason

Arm Description

To assess the efficacy of bortezomib, cyclophosphamide and dexamethasone during re-induction and in maintenance therapy. To assess the safety of bortezomib, cyclophosphamide and dexamethasone during re-induction and in maintenance therapy in patients with refractory or relapsed multiple myeloma.

Outcomes

Primary Outcome Measures

Toxicity of induction chemotherapy according to CTCAE version 3.0

Secondary Outcome Measures

Progression Free Survival
Overall Survival

Full Information

First Posted
February 17, 2014
Last Updated
June 8, 2015
Sponsor
University Medical Center Groningen
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1. Study Identification

Unique Protocol Identification Number
NCT02467010
Brief Title
Relapse Myeloma; Cyclofosfamide; Bortezomib; Maintenance
Acronym
REMM
Official 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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Groningen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Bortezomib, cyclophosphamide, dexamethason, multiple myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bortezomib, cyclophosphamide, dexamethason
Arm Type
Experimental
Arm Description
To assess the efficacy of bortezomib, cyclophosphamide and dexamethasone during re-induction and in maintenance therapy. To assess the safety of bortezomib, cyclophosphamide and dexamethasone during re-induction and in maintenance therapy in patients with refractory or relapsed multiple myeloma.
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Other Intervention Name(s)
Velcade
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Other Intervention Name(s)
Endoxan
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
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 Outcome Measure Information:
Title
Toxicity of induction chemotherapy according to CTCAE version 3.0
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Progression Free Survival
Time Frame
5 years
Title
Overall Survival
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sjoerd Hovenga
Organizational Affiliation
Nij Smellinghe Hospital Drachten
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

Relapse Myeloma; Cyclofosfamide; Bortezomib; Maintenance

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