Stem Cell Transplantation and Maintenance Therapy with Thalidomide / DLI for patients with Multiple Myeloma

Autologous-Allogeneic Tandem Stem Cell Transplantation and Maintenance Therapy with Thalidomide / DLI for patients with Multiple Myeloma (MM) and age <= 60 years: A phase II-study - Auto-Allo-TSCT in MM with Thalidomide

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-004928-21-DE

Enrollment

220

Registered

2008-03-28

Start date

2008-06-27

Completion date

Unknown

Last updated

2020-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma Stage II or III according to Salmon and Durie MedDRA version: 20.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864

Interventions

Trade Name: Thalidomid Celgene Pharmaceutical Form: Capsule, hard INN or Proposed INN: THALIDOMIDE CAS Number: 50351 Concentration unit: mg milligram(s) Concentration type: equal Concentration number:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Multiple Myeloma Stage II or III according to Salmon and Durie (see Protocol Appendix ?30.5 on page 75) • Patient's age: 18 – 60 years. • Patient's written informed consent. • Compliance with “Thalidomide Pregnancy Prevention Plan for Subjects in Clinical Trials” (see Protocol Appendix 30.14 on page 118); becoming effective with protocol version August 27, 2015. • A maximum of eight chemotherapy cycles prior to registration (CR / PR / MR / or PD).(Melphalan containing regimen should be avoided as induction therapy) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 220 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: •More than eight chemotherapy cycles prior to registration. •Severe irreversible renal, hepatic, pulmonary or cardiac disease, such as •Total bilirubin, SGPT or SGOT > 3 times upper the normal level. •Left ventricular ejection fraction 61 years.

Design outcomes

Primary

Measure	Time frame
Main Objective: Event-free survival four years after auto-allo tandem-transplantation and maintenance therapy with thalidomide in comparison to those patients without a suitable donor, who will receive tandem autologous stem cell transplantation followed by thalidomide maintenance therapy. Any of the following occurrences will be considered an endpoint event: •recurrence or progression of the primary disease, •disease related mortality, or •treatment related mortality. ;Secondary Objective: •Incidence of acute graft-versus-host disease on day +100 after allogeneic stem cell trans¬plantation according to the acc. to the Glucksberg scale revised by Przepiorka et al. •Incidence of chronic graft-versus-host disease according to the revised Seattle criteria of Lee et al. at one and two years after allogeneic stem cell transplantation. •Toxicity of conditioning and of maintenance therapy according to adverse events according to the reporting guidelines as per NCI CTCAE •Cumulative incidence of relapse at four years after auto-allo and auto-auto stem cell transplantation. •Disease related mortality at four years after allogeneic stem cell transplantation. •Treatment related mortality at four years after allogeneic stem cell transplantation. •Overall survival at four years after allogeneic stem cell transplantation. ;Primary end point(s): Event-free survival four years after auto-allo tandem-transplantation and maintenance therapy with thalidomide in comparison to those patients without a suitable donor, who will receive tandem autologous stem cell transplantation followed by thalidomide maintenance therapy. Any of the following occurrences will be considered an endpoint event: •recurrence or progression of the primary disease, •disease related mortality, or •treatment related mortality. ;Timepoint(s) of evaluation of this end point: four years after auto-allo tandem-transplantation	—

Measure

Time frame

Main Objective: Event-free survival four years after auto-allo tandem-transplantation and maintenance therapy with thalidomide in comparison to those patients without a suitable donor, who will receive tandem autologous stem cell transplantation followed by thalidomide maintenance therapy. Any of the following occurrences will be considered an endpoint event: •recurrence or progression of the primary disease, •disease related mortality, or •treatment related mortality. ;Secondary Objective: •Incidence of acute graft-versus-host disease on day +100 after allogeneic stem cell trans¬plantation according to the acc. to the Glucksberg scale revised by Przepiorka et al. •Incidence of chronic graft-versus-host disease according to the revised Seattle criteria of Lee et al. at one and two years after allogeneic stem cell transplantation. •Toxicity of conditioning and of maintenance therapy according to adverse events according to the reporting guidelines as per NCI CTCAE •Cumulative incidence of relapse at four years after auto-allo and auto-auto stem cell transplantation. •Disease related mortality at four years after allogeneic stem cell transplantation. •Treatment related mortality at four years after allogeneic stem cell transplantation. •Overall survival at four years after allogeneic stem cell transplantation. ;Primary end point(s): Event-free survival four years after auto-allo tandem-transplantation and maintenance therapy with thalidomide in comparison to those patients without a suitable donor, who will receive tandem autologous stem cell transplantation followed by thalidomide maintenance therapy. Any of the following occurrences will be considered an endpoint event: •recurrence or progression of the primary disease, •disease related mortality, or •treatment related mortality. ;Timepoint(s) of evaluation of this end point: four years after auto-allo tandem-transplantation

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Secondary

Measure	Time frame
Secondary end point(s): • Incidence of acute graft-versus-host disease on day +100 after allogeneic stem cell trans-plantation according to the acc. to the Glucksberg scale revised by Przepiorka et al.. • Incidence of chronic graft-versus-host disease according to the revised Seattle criteria of Lee et al. at one and two years after allogeneic stem cell transplantation. • Toxicity of conditioning and of maintenance therapy according to adverse events according to the reporting guidelines as per NCI CTCAE. • Cumulative incidence of relapse at four years after auto-allo and auto-auto stem cell transplantation. • Disease related mortality at four years after allogeneic stem cell transplantation. • Treatment related mortality at four years after allogeneic stem cell transplantation. • Overall survival at four years after allogeneic stem cell transplantation. ;Timepoint(s) of evaluation of this end point: four years after allogeneic stem cell transplantation except chronic graft-versus-host disease (one and two years after allogeneic stem cell transplantation) and acute graft-versus-host disease (on day +100 after allogeneic stem cell trans-plantation)	—

Measure

Time frame

Secondary end point(s): • Incidence of acute graft-versus-host disease on day +100 after allogeneic stem cell trans-plantation according to the acc. to the Glucksberg scale revised by Przepiorka et al.. • Incidence of chronic graft-versus-host disease according to the revised Seattle criteria of Lee et al. at one and two years after allogeneic stem cell transplantation. • Toxicity of conditioning and of maintenance therapy according to adverse events according to the reporting guidelines as per NCI CTCAE. • Cumulative incidence of relapse at four years after auto-allo and auto-auto stem cell transplantation. • Disease related mortality at four years after allogeneic stem cell transplantation. • Treatment related mortality at four years after allogeneic stem cell transplantation. • Overall survival at four years after allogeneic stem cell transplantation. ;Timepoint(s) of evaluation of this end point: four years after allogeneic stem cell transplantation except chronic graft-versus-host disease (one and two years after allogeneic stem cell transplantation) and acute graft-versus-host disease (on day +100 after allogeneic stem cell trans-plantation)

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Countries

Germany

Contacts

Public ContactCoordinating Principal Investigator

University Medical Center Hamburg-Eppendorf

nkroeger@uke.uni-hamburg.de+4940741054850

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026