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Tandem Melphalan and Autolog. SCT in MM Patients 60 to 70 Years of Age With and Without Induction Chemotherapy

NCT ID: NCT02288741

Last Updated: 2014-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

549 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-08-31

Study Completion Date

2012-09-30

Brief Summary

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Patients 60 to 70 years of age with newly diagnosed multiple myeloma were prospectively randomized between 4 cycles of anthracycline/dexamethasone-based induction chemotherapy (A1) or only 2 x 4 days of dexamethasone (A2). A reference arm included patients who could not be randomized (B). Tandem melphalan 140 mg/m² (MEL140) with autologous transplantation was scheduled for all patients.

Detailed Description

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In arm A1, patients received 4 cycles of conventional induction therapy with anthracycline/dexamethasone-based regimens. Specified in the protocol were vincristine/doxorubicin/dexamethasone (VAD), idarubicin/dexamethasone (ID) and cyclophosphamide/doxorubicin/dexamethasone (CAD). In arm A2, patients were planned to receive only dexamethasone 40 mg orally on days 1-4 and 8-11 for symptom control before stem cell mobilization. For the patients in arm B, a maximum of 6 cycles of induction chemotherapy was allowed. Following this, the treatment was identical for all patients. For stem cell mobilization, an age-adjusted IEV-regimen with granulocyte-colony stimulating factor (G-CSF) was recommended. The target dose for stem cell collection was 6 x 10E+6 CD34 (cluster of differentiation 34)-positive cells/kg (2 transplants and one back-up). The standard dose for each transplantation was 2 x 10E+6 CD34-positive cells/kg. High-dose melphalan at a total dose of 140 mg/m² (MEL140) was given in two doses of 70 mg/m² on days -3 and -2. Stem cell transplantation (SCT) was performed on day 0. A second MEL140 course was planned two months after the first. Regular bisphosphonate treatment was recommended.

Conditions

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Multiple Myeloma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A1: Induction chemotherapy

Anthracycline/dexamethasone-based induction chemotherapy Tumor-reduction chemotherapy and stem cell mobilization Stem cell apheresis Tandem high-dose chemotherapy Autologous peripheral blood stem cell transplantation

Group Type EXPERIMENTAL

Anthracycline/dexamethasone-based induction chemotherapy

Intervention Type DRUG

4 cycles of anthracycline/dexamethasone-based chemotherapy

Tumor-reduction chemotherapy and stem cell mobilization

Intervention Type DRUG

Ifosfamide (day 1-3: 1.900mg/m² iv), epirubicin (day 1: 75 mg/m² iv), etoposide (day 1-3: 120 mg/m² iv) and G-CSF (day 5 until end of apheresis: 5µg/kg sc)

Stem cell apheresis

Intervention Type PROCEDURE

stem cell apheresis in peripheral blood, sought amount of CD34-cells: 6 \* 10E6/kg

Tandem high-dose chemotherapy (melphalan)

Intervention Type DRUG

Two cycles of high-dose melphalan (day -3 and day -2: 70mg/m²)

Autologous peripheral blood stem cell transplantation

Intervention Type PROCEDURE

Two infusions of collected stem cells (day 0: 2\*10E6 CD34-cell/kg per transplantation)

A2: No induction chemotherapy

Dexamethasone for control of symptoms Tumor-reduction chemotherapy and stem cell mobilization Stem cell apheresis Tandem high-dose chemotherapy Autologous peripheral blood stem cell transplantation

Group Type ACTIVE_COMPARATOR

Dexamethasone for control of symptoms

Intervention Type DRUG

2 x 4 days of dexamethasone (day 1-4 and day 8-11: 40mg)

Tumor-reduction chemotherapy and stem cell mobilization

Intervention Type DRUG

Ifosfamide (day 1-3: 1.900mg/m² iv), epirubicin (day 1: 75 mg/m² iv), etoposide (day 1-3: 120 mg/m² iv) and G-CSF (day 5 until end of apheresis: 5µg/kg sc)

Stem cell apheresis

Intervention Type PROCEDURE

stem cell apheresis in peripheral blood, sought amount of CD34-cells: 6 \* 10E6/kg

Tandem high-dose chemotherapy (melphalan)

Intervention Type DRUG

Two cycles of high-dose melphalan (day -3 and day -2: 70mg/m²)

Autologous peripheral blood stem cell transplantation

Intervention Type PROCEDURE

Two infusions of collected stem cells (day 0: 2\*10E6 CD34-cell/kg per transplantation)

B: Observation

Tumor-reduction chemotherapy and stem cell mobilization Stem cell apheresis Tandem high-dose chemotherapy Autologous peripheral blood stem cell transplantation

Group Type OTHER

Anthracycline/dexamethasone-based induction chemotherapy

Intervention Type DRUG

4 cycles of anthracycline/dexamethasone-based chemotherapy

Tumor-reduction chemotherapy and stem cell mobilization

Intervention Type DRUG

Ifosfamide (day 1-3: 1.900mg/m² iv), epirubicin (day 1: 75 mg/m² iv), etoposide (day 1-3: 120 mg/m² iv) and G-CSF (day 5 until end of apheresis: 5µg/kg sc)

Stem cell apheresis

Intervention Type PROCEDURE

stem cell apheresis in peripheral blood, sought amount of CD34-cells: 6 \* 10E6/kg

Tandem high-dose chemotherapy (melphalan)

Intervention Type DRUG

Two cycles of high-dose melphalan (day -3 and day -2: 70mg/m²)

Autologous peripheral blood stem cell transplantation

Intervention Type PROCEDURE

Two infusions of collected stem cells (day 0: 2\*10E6 CD34-cell/kg per transplantation)

Interventions

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Anthracycline/dexamethasone-based induction chemotherapy

4 cycles of anthracycline/dexamethasone-based chemotherapy

Intervention Type DRUG

Dexamethasone for control of symptoms

2 x 4 days of dexamethasone (day 1-4 and day 8-11: 40mg)

Intervention Type DRUG

Tumor-reduction chemotherapy and stem cell mobilization

Ifosfamide (day 1-3: 1.900mg/m² iv), epirubicin (day 1: 75 mg/m² iv), etoposide (day 1-3: 120 mg/m² iv) and G-CSF (day 5 until end of apheresis: 5µg/kg sc)

Intervention Type DRUG

Stem cell apheresis

stem cell apheresis in peripheral blood, sought amount of CD34-cells: 6 \* 10E6/kg

Intervention Type PROCEDURE

Tandem high-dose chemotherapy (melphalan)

Two cycles of high-dose melphalan (day -3 and day -2: 70mg/m²)

Intervention Type DRUG

Autologous peripheral blood stem cell transplantation

Two infusions of collected stem cells (day 0: 2\*10E6 CD34-cell/kg per transplantation)

Intervention Type PROCEDURE

Other Intervention Names

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ID, VAD, CAD dexamethasone IEV + G-CSF SC-apheresis Tandem melphalan PBSCT

Eligibility Criteria

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Inclusion Criteria

* Histological confirmed multiple myeloma stage II or III according to the classification of Salmon and Durie
* Aged between 60 and 70 years
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Signed and dated written informed consent
* No previous chemotherapy or not more than one cycle in total or previous chemotherapy of more than one cycle if paused for at least 6 months and not more than six cycles in total (arm A1 and A2 only)
* Ongoing primary chemotherapy of two to maximum six cycles (arm B only)

Exclusion Criteria

* Multiple myeloma stage I according to the classification of Salmon and Durie without need of any therapy
* Aged under 60 or over 70 years
* ECOG performance status \>2
* Previous chemotherapy of more than six cycles
* Informed consent missing
* Myocardial infarction within the last six months
* Cardiac dysrhythmia stage IV b according to the classification of Lown
* Heart failure \>NYHA II according to the classification of the New York Heart Association (NYHA), left ventricular ejection fraction \<50% in ECG
* Severe restrictive or obstructive pulmonary disease (diffusing capacity \<60% under normal)
* Renal insufficiency including a serum creatinine level \>2mg/dl if not caused by multiple myeloma and reversible
* Liver diseases combined with an elevation of transaminases and of bilirubin of three times above normal
* Severe infections (HIV, hepatitis B/C, syphilis etc. )
* Severe psychiatric disease
* Other not curative treated malignant tumor within the last five years
* Concurrent participation in other clinical studies
* Other not curative treated malignant tumor within the last five years
Minimum Eligible Age

60 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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WiSP Wissenschaftlicher Service Pharma GmbH

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christian Straka, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Schön Klink Starnberger See

References

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Blade J, Samson D, Reece D, Apperley J, Bjorkstrand B, Gahrton G, Gertz M, Giralt S, Jagannath S, Vesole D. Criteria for evaluating disease response and progression in patients with multiple myeloma treated by high-dose therapy and haemopoietic stem cell transplantation. Myeloma Subcommittee of the EBMT. European Group for Blood and Marrow Transplant. Br J Haematol. 1998 Sep;102(5):1115-23. doi: 10.1046/j.1365-2141.1998.00930.x. No abstract available.

Reference Type BACKGROUND
PMID: 9753033 (View on PubMed)

Alexanian R, Barlogie B, Tucker S. VAD-based regimens as primary treatment for multiple myeloma. Am J Hematol. 1990 Feb;33(2):86-9. doi: 10.1002/ajh.2830330203.

Reference Type BACKGROUND
PMID: 2301376 (View on PubMed)

Clark AD, Douglas KW, Mitchell LD, McQuaker IG, Parker AN, Tansey PJ, Franklin IM, Cook G. Dose escalation therapy in previously untreated patients with multiple myeloma following Z-Dex induction treatment. Br J Haematol. 2002 Jun;117(3):605-12. doi: 10.1046/j.1365-2141.2002.03519.x.

Reference Type BACKGROUND
PMID: 12028028 (View on PubMed)

Straka C, Hebart H, Adler-Reichel S, Werding N, Emmerich B, Einsele H. Blood stem cell collections after mobilization with combination chemotherapy containing ifosfamide followed by G-CSF in multiple myeloma. Oncology. 2003;65 Suppl 2:94-8. doi: 10.1159/000073368.

Reference Type BACKGROUND
PMID: 14586157 (View on PubMed)

Szelenyi H, Kreuser ED, Keilholz U, Menssen HD, Keitel-Wittig C, Siehl J, Knauf W, Thiel E. Cyclophosphamide, adriamycin and dexamethasone (CAD) is a highly effective therapy for patients with advanced multiple myeloma. Ann Oncol. 2001 Jan;12(1):105-8. doi: 10.1023/a:1008362107080.

Reference Type BACKGROUND
PMID: 11249035 (View on PubMed)

Straka C, Liebisch P, Salwender H, Hennemann B, Metzner B, Knop S, Adler-Reichel S, Gerecke C, Wandt H, Bentz M, Bruemmendorf TH, Hentrich M, Pfreundschuh M, Wolf HH, Sezer O, Bargou R, Jung W, Trumper L, Hertenstein B, Heidemann E, Bernhard H, Lang N, Frickhofen N, Hebart H, Schmidmaier R, Sandermann A, Dechow T, Reichle A, Schnabel B, Schafer-Eckart K, Langer C, Gramatzki M, Hinke A, Emmerich B, Einsele H. Autotransplant with and without induction chemotherapy in older multiple myeloma patients: long-term outcome of a randomized trial. Haematologica. 2016 Nov;101(11):1398-1406. doi: 10.3324/haematol.2016.151860. Epub 2016 Aug 4.

Reference Type DERIVED
PMID: 27662018 (View on PubMed)

Other Identifiers

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protocol version 08/01/2001

Identifier Type: OTHER

Identifier Source: secondary_id

WiSP_AM71

Identifier Type: -

Identifier Source: org_study_id