Download PDF

Clinical Trial Results:
Cyclophosphamide as graft-versus-host prophylaxis after allogeneic stem cell transplantation for multiple myeloma. A phase II study.

Summary
EudraCT number	2016-002557-38
Trial protocol	DE
Global end of trial date	01 Dec 2022

Results information
Results version number	v1(current)
This version publication date	09 Oct 2026
First version publication date	09 Oct 2026
Other versions
Summary report(s)	Summary results

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

Allo-MM-PostCy-Study

ISRCTN number

US NCT number

NCT03700450

WHO universal trial number (UTN)

Sponsor organisation name

University Medical Center Hamburg Eppendorf

Sponsor organisation address

Martinistr. 52, Hamburg, Germany, 20246

Public contact

Study Investigator, Department of Stem Cell Transplantation University Medical Center Hamburg-Eppendorf, bmt@uke.de

Scientific contact

Study Investigator, Department of Stem Cell Transplantation University Medical Center Hamburg-Eppendorf, bmt@uke.de

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

01 Dec 2022

Is this the analysis of the primary completion data?

Yes

Primary completion date

01 Dec 2022

Global end of trial reached?

Yes

Global end of trial date

01 Dec 2022

Was the trial ended prematurely?

Main objective of the trial

The primary endpoint of the study is chronic GvHD and progression-free survival at 2 years after transplantation.

Protection of trial subjects

This study was conducted in accordance with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) regulations/guidelines, the general principles indicated in the Declaration of Helsinki, and all applicable regulatory requirements. Prior to study initiation the study protocol was reviewed and approved by an Independent Ethics Committee (IEC). The study, all study procedures and the risks and benefits were explained to the subjects by responsible investigators and written informed consent were collected prior to any study related examinations. A clinical monitor visited the Investigator at regular time intervals during the course of the study to review the progress and conduct of the study and verfies the protection of subject's rights and safety.

Background therapy

Graft Source for Allogeneic SCT: Peripheral blood stem cells (PBSC) or bone marrow stem cells (BM) The patient received the following conditioning regime before SCT: < 60 years of age: thiotepa 2 x 5 mg/kg BW, busulfan 3 x 3.2 mg/kg BW a day > 60 years of age: thiotepa 2 x 5 mg/kg BW, busulfan 2 x 3.2 mg/kg BW a day In case of haploidentical transplantation additional fludarabine 5 x 30 mg/m2 was given. Busulfan was administered as intravenous application once daily. Anti-epileptic drug should have been used to prevent seizure with busulfan. Fludarabine at a dose of 30 mg/m2 was given intravenously as short infusion from day -6 to day -2.

Evidence for comparator

Actual start date of recruitment

10 Apr 2018

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Germany: 36

Worldwide total number of subjects

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

Top of page

Recruitment details

This study was conducted in Germany. 3 active study centers were involved.

Screening details

Screening period: up to 28 days before Day 0 (Allo SCT) Main Inclusion Criteria: Multiple myeloma newly diagnosed with deletion 17p or translocation 4;14 or multiple myeloma with 1. or 2. relapse after auto SCT; Patients age: 18 - 65 years; ECOG </= 2; Availability of haploidentical, matched or mismatched relative or unrelated donor

Number of subjects started

Number of subjects completed

Period 1 title

Treatment period (overall period)

Is this the baseline period?

Yes

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

Blinding implementation details

unblinded, all patients received on day 3 and 4 after allogeneic stem cell transplantation (day 0) 50 mg/kg BW cyclophosphamide.

additional GvHD prophylaxis: Cyclophosphamid

Arm description

cyclophosphamide 50 mg/kg BW at day +3 and day +4 and as outlined: - in case of haploidentical SCT/MMRD: plus tacrolimus (day +5 until +180) and MMF (day +5 until day +35) - in case of MUD: plus cyclosporine A (day +5 until +120) and MMF (day +5 until day +35) - in case of MMUD: plus cyclosporine A (day +5 until +180) and MMF (day +5 until day +35) - in case of MRD: plus cyclosporine A (day +5 until +120)

Arm type

Experimental

Investigational medicinal product name

cyclophosphamide

Investigational medicinal product code

not applicable, since Cyclophosphamide was applied

Other name

Pharmaceutical forms

Infusion

Routes of administration

Intravenous use

Dosage and administration details

Dose: 2 x 50 mg/kg body weight (BW) on day +3 and +4 after allo SCT Mode of administration: intravenously (iv)

Number of subjects in period 1	additional GvHD prophylaxis: Cyclophosphamid
Started	36
Completed	26
Not completed	10
Adverse event, serious fatal	9
Adverse event, non-fatal	1

Baseline characteristics

Top of page

Reporting group title

Treatment period

Reporting group description

Reporting group values	Treatment period	Total
Number of subjects	36	36
Age categorical
Units: Subjects
In utero	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0
Newborns (0-27 days)	0	0
Infants and toddlers (28 days-23 months)	0	0
Children (2-11 years)	0	0
Adolescents (12-17 years)	0	0
Adults (18-64 years)	34	34
From 65-84 years	2	2
85 years and over	0	0
Age continuous
Units: years
arithmetic mean (standard deviation)	53.2 ( 7.1 )	-
Gender categorical
Safety Population
Units: Subjects
Female	14	14
Male	22	22
Results of cytogenic abnormalities
Units: Subjects
Normal	3	3
Abnormalities	26	26
Missing data	7	7
Specifications of abnormalities
Units: Subjects
Translocation t(4; 14) (alone or with further abn.	5	5
Deletion 17p (del17p) (alone or with further abn.	2	2
both: t(4;14), del17p	1	1
+1q21 (alone or with further abnormalities)	6	6
Other abnormalities	12	12
Missing data	10	10
Relapse after 1. autologous stem cell transplantation
Units: Subjects
Yes	26	26
No	10	10
Relapse after 2. autologous stem cell transplantation
Units: Subjects
Yes	6	6
No	3	3
NA	27	27
Number of patients of previous auto SCT (autograft)
The value for “Number 2.auto SCT” is “9”, not “0”. Due to a system error, the value could not be entered. Error message: "The total number of subjects for all categories in the study specific categorical characteristic are not the same as the total number of subjects in the baseline period. Ensure the number of subjects recorded for the categories account for all subjects in the baseline period". However, the value “9” is correct, as these patients receive both the first and the second SCT.
Units: Subjects
1. auto SCT	36	36
2. auto SCT	0	0
Relationship between stem cell donor and recipient
Units: Subjects
MRD	6	6
MUD	22	22
MMUD	4	4
MMRD	0	0
Haploidentical	4	4
Sorror Risk Score
Units: Subjects
<= 3	33	33
> 3	3	3
Conditioning age group
unit Thiotepa and Busulfan: mg/ Kg body weight i.v.
Units: Subjects
> 60 years: Thiotepa (2x5mg), Busulfan (2x3.2mg)	6	6
<= 60 years: Thiotepa (2x5mg), Busulfan (3x3.2mg)	30	30
ECOG status at study inclusion
Units: Subjects
Fully active	18	18
Restricted in physically strenuous activity	17	17
Ambulatory and capable of all self-care	1	1
Capable of only limited self-care	0	0
Completely disabled	0	0
Dead	0	0
Type of Myeloma
Units: Subjects
IgG	19	19
IgA	11	11
IgD	0	0
IgE	0	0
Light Chain	6	6
nonsecretory	0	0
Time from auto SCT to relapse (<= 12 months vs >12 months)
Units: Subjects
<= 12 months	9	9
>12 months	16	16
Missing	11	11
Time from auto SCT to relapse (<= 15 months vs >15 months)
Units: Subjects
<= 15 months	12	12
>15 months	13	13
Missing	11	11
Age median
Units: Years
median (full range (min-max))	54.0 (35 to 66)	-

End points

Top of page

Reporting group title

additional GvHD prophylaxis: Cyclophosphamid

Reporting group description

Primary: Chronic GvHD and progression-free survival at 2 years after allogeneic SCT

Top of page

End point title

Chronic GvHD and progression-free survival at 2 years after allogeneic SCT ^[1]

End point description

Efficacy analyses will be done using the FAP population (and possibly additionally the PPP population). All statistical tests, including the statistical test of the primary efficacy endpoint, will be two-sided at a significance level of 5%. All reported confidence intervals will be two-sided with confidence level 95%. Chronic GvHD and progression-free survival is defined as the probability of being alive with no sign of relapse or progression and without any chronic GvHD of grade ‘moderate’ or ‘severe’. The associated time span is defined as the interval from Day 0 to relapse or progression or death due to any cause or chronic GvHD of grade ‘moderate’ or ‘severe’, whatever comes first. To compare cGRFS at 2 years after allogeneic SCT between the single arm ‘MultMyelom’ of this study and historical reference data, a two-sided z-test with a 5.0% significance level will be performed and the corresponding two-sided p-value will be presented.

End point type

Primary

End point timeframe

2 years after transplantation

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Please refer to "End point description"

End point values	additional GvHD prophylaxis: Cyclophosphamid
Number of subjects analysed	36
Units: Proportion
number (confidence interval 95%)
2 years after SCT	0.389 (0.258 to 0.586)
1 year from start of salvage therapy	0.846 (0.718 to 0.997)
2 years from start of salvage therapy	0.615 (0.454 to 0.834)

Attachments

Chronice GvHD and progression-free survival

No statistical analyses for this end point

Secondary: Non-relapse mortality (NRM) at 2 years after allogeneic SCT

Top of page

End point title

Non-relapse mortality (NRM) at 2 years after allogeneic SCT

End point description

Non-relapse mortality will be defined as the probability of dying without previousoccurrence of a relapse or progressive disease. The associated time span is defined as the interval from date of SCT (Day 0) (Database: f_allo-sct: i_tx-sct-date) to death, without previous relapse or progressive disease. Relapse or progressive disease is considered a competing event with the associated time span from date of SCT (Day 0) to relapse or progressive disease. Patients alive without relapse or progressive disease are censored at last contact. A patient experienced a relapse/progressive disease (first relapse/progressive disease) if the documented response status at any time is relapse/progressive disease. Cumulative incidence functions will be estimated for the competing events • relapse (first relapse) or progressive disease (first progressive disease) • death before any relapse/progressive disease for treatment arm ‘MultMyelom’ over 2 years after allo-SCT. The NRM rate as well as the

End point type

Secondary

End point timeframe

2 years after allogeneic SCT

End point values	additional GvHD prophylaxis: Cyclophosphamid
Number of subjects analysed	36
Units: Proportion
number (confidence interval 95%)
100 days: Non-relapse mortality	0.111 (0.035 to 0.238)
100 days: Relapse	0.000 (0 to 0)
1 year: Non-relapse mortality	0.111 (0.035 to 0.238)
1 year: Relapse	0.139 (0.050 to 0.273)
2 years: Non-relapse mortality	0.111 (0.035 to 0.238)
2 years: Relapse	0.472 (0.301 to 0.626)

Attachments

NRM at 2 year after allogeneic SCT

No statistical analyses for this end point

Secondary: Incidence of acute GvHD on Day +100 after allogeneic SCT

Top of page

End point title

Incidence of acute GvHD on Day +100 after allogeneic SCT

End point description

Incidence of acute GvHD of grade II-IV until Day +100 after allogeneic SCT: Incidence of acute GvHD of grade II-IV until Day +100 after allogeneic SCT will be defined as the probability of experiencing any acute GvHD event of grade II-IV within 100 days after allogeneic SCT. The associated time span is defined as the interval from date of SCT (Day 0)

End point type

Secondary

End point timeframe

Day +100 after allogeneic SCT

End point values	additional GvHD prophylaxis: Cyclophosphamid
Number of subjects analysed	36
Units: Proportion
number (confidence interval 95%)
Acute GvHD of grade II-IV (100 days)	0.111 (0.034 to 0.238)
Death before acute GvHD of grade II-IV (100 days)	0.083 (0.021 to 0.203)
Acute GvHD of grade III/IV (100 days)	0.056 (0.010 to 0.165)
Death before acute GvHD of grade III-IV (100days)	0.083 (0.021 to 0.203)

Attachments

Incidence of acute GvHD

No statistical analyses for this end point

Secondary: Incidence of chronic GvHD at 1 and 2 years after allogeneic SCT

Top of page

End point title

Incidence of chronic GvHD at 1 and 2 years after allogeneic SCT

End point description

Incidence of chronic GvHD until 1 year (2 years) after allogeneic SCT will be defined as the probability of experiencing any chronic GvHD event within 1 year (2 years) after allogeneic SCT. The associated time span is defined as the interval from date of SCT (Day 0) to the first chronic GvHD event.

End point type

Secondary

End point timeframe

1 and 2 years after allogeneic SCT

End point values	additional GvHD prophylaxis: Cyclophosphamid
Number of subjects analysed	36
Units: Proportion
number (confidence interval 95%)
1 year: chronic GvHD	0.417 (0.253 to 0.573)
1 year: Death before chronic GvHD	0.194 (0.084 to 0.339)
2 years: Chronic GvHD	0.417 (0.253 to 0.573)
2 years: Death before chronic GvHD	0.222 (0.102 to 0.371)

Attachments

Incidence of chronic GvHD

No statistical analyses for this end point

Secondary: Toxicity according to NCI

Top of page

End point title

Toxicity according to NCI

End point description

P1: Study period until first IMP intake P2: Study period after IMP intake The endpoint ‘5. Toxicity according to NCI’ will be evaluated as a safety endpoint.

End point type

Secondary

End point timeframe

entire study period

End point values	additional GvHD prophylaxis: Cyclophosphamid
Number of subjects analysed	33 ^[2]
Units: Number of patients
P1: Pts. with any AE of tox. grade III or higher	9
P1: Pts. with severe AEs of tox. grade III or high	0
P2: Pts. with any AE of tox. grade III or higher	27
P2: Pts. with severe AEs of tox. grade III or high	2

Attachments

Toxicity according to NCI

Notes
[2] - Safety Population (SP): include all patients who are registered and received SCT.

No statistical analyses for this end point

Secondary: Complete remission rate (including sCR and MRD negativity)

Top of page

End point title

Complete remission rate (including sCR and MRD negativity)

End point description

Incidence of complete remission or stringent complete remission until 1 year (2 years) after allogeneic SCT will be defined as the probability of experiencing complete remission or stringent complete remission within 1 year (2 years) after allogeneic SCT. The associated time span is defined as the interval from date of SCT (Day 0) ) to complete remission or stringent complete remission, whatever comes first.

End point type

Secondary

End point timeframe

entire study period

End point values	additional GvHD prophylaxis: Cyclophosphamid
Number of subjects analysed	36
Units: Proportion
number (confidence interval 95%)
1 year: Complete remission (including sCR)	0.639 (0.454 to 0.775)
1 year: Death before complete remission (incl. sCR	0.139 (0.049 to 0.274)
2 years: Complete remission (including sCR)	0.778 (0.593 to 0.886)
2 years: Death before complete remission (inc. sCR	0.139 (0.049 to 0.274)

Attachments

Complete remission rate

No statistical analyses for this end point

Secondary: Overall and progression-free survival at 2 years

Top of page

End point title

Overall and progression-free survival at 2 years

End point description

Overall survival (OS) will be defined as the probability of surviving a specific time. Survival time is defined as the time from Day 0t o death due to any cause. Progression-free survival (PFS) is defined as the probability of being alive with no sign of relapse or progression. The associated time span is defined as the interval from Day 0 to relapse or progression or death due to any cause, whatever comes first. A relapse / progression, and death from any cause will be considered an event. Patients alive without progression or relapse are censored at the last time without indication of an event. Firstly, the Kaplan-Meier estimate for the survivor function will be calculated to assess the progression-free survival rate for treatment group ‘MultMyelom’ at 2 years after allogeneic SCT. Secondly, the standard error for this survival rate will be calculated using Greenwood’s formula. The survival rate for treatment group ‘MultMyelom’ at 2 years after allogeneic SCT [...]

End point type

Secondary

End point timeframe

2 years

End point values	additional GvHD prophylaxis: Cyclophosphamid
Number of subjects analysed	36
Units: Proportion
number (confidence interval 95%)
Overall Survival 1 year after SCT	0.806 (0.686 to 0.946)
Overall Survival 2 years after SCT	0.722 (0.590 to 0.884)
Progression-free Survival 1 year after SCT	0.750 (0.621 to 0.906)
Progression-free Survival 2 years after SCT	0.417 (0.283 to 0.613)

Attachments

Overall and progression-free survival at 2 years

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

All AEs CTCAE grade 3-5 were collected and recorded in the eCRF from the time point of signed informed consent until the end of the study. Exceptions were defined by protocol.

Adverse event reporting additional description

Immediate SAE reporting (within 24h) until 28d after SCT.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

27.0

Reporting group title

Adverse events - Period 1 (until first IMP intake)

Reporting group description

Period 1= from date of eligibility to date of first intake of IMP. This includes SCT and days 1 and 2 after Allo SCT as per protocol flow chart. The number "Subjects affected by serious adverse events": 0 is incorrect but must be provided due to an system error. Only AEs are presented.

Reporting group title

Adverse events - Period 2 (after IMP intake)

Reporting group description

Period 2= from date of first intake of IMP untill end of study visit. The number "Subjects affected by serious adverse events": 0 is incorrect but must be provided due to an system error. Only AEs are presented.

Serious adverse events	Adverse events - Period 1 (until first IMP intake)	Adverse events - Period 2 (after IMP intake)
Total subjects affected by serious adverse events
subjects affected / exposed	0 / 36 (0.00%)	0 / 36 (0.00%)
number of deaths (all causes)	4	10
number of deaths resulting from adverse events

Frequency threshold for reporting non-serious adverse events: 0%

Non-serious adverse events	Adverse events - Period 1 (until first IMP intake)	Adverse events - Period 2 (after IMP intake)
Total subjects affected by non serious adverse events
subjects affected / exposed	15 / 36 (41.67%)	33 / 36 (91.67%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Any
subjects affected / exposed	0 / 36 (0.00%)	6 / 36 (16.67%)
occurrences all number	0	6
Vascular disorders
Any
subjects affected / exposed	1 / 36 (2.78%)	5 / 36 (13.89%)
occurrences all number	1	5
General disorders and administration site conditions
Any
subjects affected / exposed	5 / 36 (13.89%)	17 / 36 (47.22%)
occurrences all number	5	17
Mucosal inflammation
subjects affected / exposed	3 / 36 (8.33%)	13 / 36 (36.11%)
occurrences all number	3	13
Prexia
subjects affected / exposed	3 / 36 (8.33%)	10 / 36 (27.78%)
occurrences all number	3	10
Immune system disorders
Any
subjects affected / exposed	1 / 36 (2.78%)	2 / 36 (5.56%)
occurrences all number	1	2
Investigations
Any
subjects affected / exposed	1 / 36 (2.78%)	7 / 36 (19.44%)
occurrences all number	1	7
Injury, poisoning and procedural complications
Any
subjects affected / exposed	2 / 36 (5.56%)	2 / 36 (5.56%)
occurrences all number	2	2
Nervous system disorders
Any
subjects affected / exposed	1 / 36 (2.78%)	4 / 36 (11.11%)
occurrences all number	1	4
Blood and lymphatic system disorders
Any
Additional description: The statistician did not specify the number of affected subjects, but only the number of events/ occurences. However, due to a system error, this entry is required. Therefore, the same number as that for the “occurences all number” was entered.
subjects affected / exposed	4 / 36 (11.11%)	4 / 36 (11.11%)
occurrences all number	4	4
Anemia
subjects affected / exposed	1 / 36 (2.78%)	2 / 36 (5.56%)
occurrences all number	1	2
Febrile Neutropenia
subjects affected / exposed	2 / 36 (5.56%)	1 / 36 (2.78%)
occurrences all number	2	1
Gastrointestinal disorders
Any
subjects affected / exposed	2 / 36 (5.56%)	5 / 36 (13.89%)
occurrences all number	2	5
Diarrhoe
subjects affected / exposed	0 / 36 (0.00%)	3 / 36 (8.33%)
occurrences all number	0	3
Hepatobiliary disorders
Any
subjects affected / exposed	0 / 36 (0.00%)	3 / 36 (8.33%)
occurrences all number	0	3
Renal and urinary disorders
Any
subjects affected / exposed	0 / 36 (0.00%)	5 / 36 (13.89%)
occurrences all number	0	5
Infections and infestations
Any
subjects affected / exposed	3 / 36 (8.33%)	20 / 36 (55.56%)
occurrences all number	3	20
Atypical pneumonia
subjects affected / exposed	0 / 36 (0.00%)	3 / 36 (8.33%)
occurrences all number	0	3
Cytomegalovirus infection reactivation
subjects affected / exposed	1 / 36 (2.78%)	5 / 36 (13.89%)
occurrences all number	1	5
Pneumonia
subjects affected / exposed	0 / 36 (0.00%)	3 / 36 (8.33%)
occurrences all number	0	3
Metabolism and nutrition disorders
Any
subjects affected / exposed	0 / 36 (0.00%)	5 / 36 (13.89%)
occurrences all number	0	5

More information

Top of page

Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Clinical trials

Clinical Trial Results:
Cyclophosphamide as graft-versus-host prophylaxis after allogeneic stem cell transplantation for multiple myeloma. A phase II study.

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Chronic GvHD and progression-free survival at 2 years after allogeneic SCT

Primary: Chronic GvHD and progression-free survival at 2 years after allogeneic SCT

Secondary: Non-relapse mortality (NRM) at 2 years after allogeneic SCT

Secondary: Non-relapse mortality (NRM) at 2 years after allogeneic SCT

Secondary: Incidence of acute GvHD on Day +100 after allogeneic SCT

Secondary: Incidence of acute GvHD on Day +100 after allogeneic SCT

Secondary: Incidence of chronic GvHD at 1 and 2 years after allogeneic SCT

Secondary: Incidence of chronic GvHD at 1 and 2 years after allogeneic SCT

Secondary: Toxicity according to NCI

Secondary: Toxicity according to NCI

Secondary: Complete remission rate (including sCR and MRD negativity)

Secondary: Complete remission rate (including sCR and MRD negativity)

Secondary: Overall and progression-free survival at 2 years

Secondary: Overall and progression-free survival at 2 years

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials

Clinical Trial Results: Cyclophosphamide as graft-versus-host prophylaxis after allogeneic stem cell transplantation for multiple myeloma. A phase II study.

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Chronic GvHD and progression-free survival at 2 years after allogeneic SCT

Primary: Chronic GvHD and progression-free survival at 2 years after allogeneic SCT

Secondary: Non-relapse mortality (NRM) at 2 years after allogeneic SCT

Secondary: Non-relapse mortality (NRM) at 2 years after allogeneic SCT

Secondary: Incidence of acute GvHD on Day +100 after allogeneic SCT

Secondary: Incidence of acute GvHD on Day +100 after allogeneic SCT

Secondary: Incidence of chronic GvHD at 1 and 2 years after allogeneic SCT

Secondary: Incidence of chronic GvHD at 1 and 2 years after allogeneic SCT

Secondary: Toxicity according to NCI

Secondary: Toxicity according to NCI

Secondary: Complete remission rate (including sCR and MRD negativity)

Secondary: Complete remission rate (including sCR and MRD negativity)

Secondary: Overall and progression-free survival at 2 years

Secondary: Overall and progression-free survival at 2 years

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
Cyclophosphamide as graft-versus-host prophylaxis after allogeneic stem cell transplantation for multiple myeloma. A phase II study.