Clinical trial · Interventional

THAL-DEX Incorporated Into Double PBSC Autotransplantation for Untreated Multiple Myeloma (MM)

Thalidomide-Dexamethasone Incorporated Into Double Autologous Stem-Cell Transplantation for Patients Less Than 65 Years of Age With Newly Diagnosed Multiple Myeloma

NCT01341262CI-TRIAL-00004722completedPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

The marked activity of thalidomide (thal) and dexamethasone (dex) in relapsed and refractory multiple myeloma (MM) provided the basis for this phase 2 clinical study aimed at investigating the efficacy and toxicity of thal-dex incorporated into melphalan-based double autologous stem cell transplantation (ASCT)for patients less than 65 years old with newly diagnosed symptomatic MM. Thal-dex was given as primary induction therapy and was then continued throughout the subsequent treatment phases until the day before the second autotransplantation. Primary study endpoints,as evaluated on an intention to treat basis, are response rates to the different treatment phases (induction, first and second ASCT), best response whenever achieved, duration of response (DOR), time to progression (TTP), progression free survival (PFS)and toxicity profile of thal-dex. Secondary endpoints, as evaluated on an intention to treat basis, are overall survival (OS) and clinical outcomes (DOR, TTP, PFS and OS)according to prognostic factors, including cytogenetic abnormalities and imaging features, as detected by 18F-FDG PET/CT.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Multiple Myeloma	Multiple Myeloma	CURATED_EXACT	0.92

Interventions

Interventions (5)

Intervention	Type	Mapped drug	Match
Cyclophosphamide	Drug	Cyclophosphamide	ALIAS
Dexamethasone	Drug	Dexamethasone	ALIAS
Melphalan	Drug	Melphalan	ALIAS
Thalidomide	Drug	Thalidomide	ALIAS
Zoledronic acid	Drug	Zoledronic Acid	ALIAS

Design

Arms and outcomes

Arms (0)

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Primary outcomes (7)

measure
Response rate (at least PR, VGPR, nCR and CR) to thal-dex induction
timeFrame
120 days after the start day of tal-dex induction therapy
description
Responses are reported by study investigators and centrally reassessed by study coordinator(s). Criteria are those initially proposed by the European Group for Blood and Marrow Transplantation (EBMT), with the addition of nCR (100% M-protein reduction by electrophoresis, but immunofixation-positive)and VGPR (at least 90% reduction of M component).
measure
duration of response (partial response, PR, very good partial response, VGPR, complete response, CR)
timeFrame
Average time period between the day of first achievement of response and the day of first relapse or progression
description
Duration of response is calculated from the first achievement of the response (at least PR, at least VGPR, at least CR) to relapse/progression
measure
time to progression (TTP)
timeFrame
Average time period between the start day of induction therapy and the day of relapse or progression

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 65 Years

Show eligibility criteria text

Inclusion criteria:

* Confirmed diagnosis of symptomatic MM based on standard criteria.
* No prior or current systemic therapy for MM, with exception of steroids.
* At least 18 years and less than 65 years of age.
* Presence of quantifiable M protein in serum or urine.
* Durie \& Salmon stage II-III or I with disease progression.
* Adequate organ function (heart, lung).
* No previous deep vein thrombosis and/or recurring thrombophlebitis and/or pulmonary embolisms, confirmed by doppler ultrasound or computed tomography scan.
* Willing and able to comply with the protocol requirements.

Exclusion criteria:

* Diagnosis of smouldering or asymptomatic MM, plasmacell leukemia, solitary plasmocytoma of the bone o extramedullary plasmocytoma.
* Diagnosis of non-secretory MM.
* Prior or current systemic therapy for MM, with exception of steroids.
* More than 65 years of age.
* Female subjects pregnant.
* Non adequate organ function (heart, lung).
* Patient has a prior history of thrombosis or venous thromboembolism or pulmonary embolism.

References

Publications (1)

DERIVEDZamagni E, Patriarca F, Nanni C, Zannetti B, Englaro E, Pezzi A, Tacchetti P, Buttignol S, Perrone G, Brioli A, Pantani L, Terragna C, Carobolante F, Baccarani M, Fanin R, Fanti S, Cavo M. Prognostic relevance of 18-F FDG PET/CT in newly diagnosed multiple myeloma patients treated with up-front autologous transplantation. Blood. 2011 Dec 1;118(23):5989-95. doi: 10.1182/blood-2011-06-361386. Epub 2011 Sep 6. PMID 21900189