NCT01090089 (DSM XIII) is a Phase 3 clinical trial of Lenalidomide, Dexamethasone in Multiple Myeloma, sponsored by Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH.

Who is sponsoring NCT01090089?

NCT01090089 is sponsored by Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH.

What drugs are being tested in NCT01090089?

Interventions in NCT01090089: Lenalidomide, Dexamethasone, Lenalidomide, Dexamethasone, PBSCT.

What condition does NCT01090089 study?

NCT01090089 studies Multiple Myeloma.

Is NCT01090089 still recruiting?

NCT01090089 is currently completed. Last updated 23 February 2023.

Last reviewed 2023-02-23 · How we verify

NCT01090089: DSM XIII

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Combination of Lenalidomide and Dexamethasone in Treatment of Multiple Myeloma

Completed Phase 3 Last updated 23 February 2023

What this trial tests

Phase 3 trial testing Lenalidomide, Dexamethasone in Multiple Myeloma in 348 participants. Completed in 31 January 2020.

Timeline

1 March 2010

Primary endpoint
31 January 2020

31 January 2020

Quick facts

Lead sponsor	Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	348
Start date	1 March 2010
Primary completion	31 January 2020
Estimated completion	31 January 2020
Sites	31 locations across Germany

Drugs / interventions tested

Lenalidomide, Dexamethasone — full drug profile →
Lenalidomide, Dexamethasone, PBSCT — full drug profile →

Conditions studied

Multiple Myeloma — all drugs for Multiple Myeloma →

Sponsor

Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH — full company profile →

Who can join

Adults 60 to 75, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In this study for elderly myeloma patients lenalidomide plus low-dose dexamethasone until progression is being compared with age-adjusted tandem high-dose melphalan 140 mg/m² augmented by induction with 3 cycles of lenalidomide plus low-dose dexamethasone before transplantation and lenalidomide maintenance after transplantation.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

The proteogenomic landscape of multiple myeloma reveals insights into disease biology and therapeutic opportunities.
Ramberger E, Sapozhnikova V, Ng YLD, Dolnik A, et al · · 2024 · cited 25× · PMID 38942927 · DOI 10.1038/s43018-024-00784-3
How I treat elderly patients with plasma cell dyscrasias.
Gavriatopoulou M, Fotiou D, Ntanasis-Stathopoulos I, Kastritis E, et al · · 2018 · cited 13× · PMID 30568029 · DOI 10.18632/aging.101707
Ikaros Proteins in Tumor: Current Perspectives and New Developments.
Xia R, Cheng Y, Han X, Wei Y, et al · · 2021 · cited 12× · PMID 34950704 · DOI 10.3389/fmolb.2021.788440
Updates on Hematologic Malignancies in the Older Adult: Focus on Acute Myeloid Leukemia, Chronic Lymphocytic Leukemia, and Multiple Myeloma.
Huang LW, Wong SW, Andreadis C, Olin RL. · · 2019 · cited 2× · PMID 30848394 · DOI 10.1007/s11912-019-0778-2
Continuous induction with lenalidomide/dexamethasone versus autologous stem cell transplantation in newly diagnosed multiple myeloma: a case for response-adapted approach.
Lahoud OB, Landau H, Nguyen J, Devlin S, et al · · 2022 · PMID 35648041 · DOI 10.1080/10428194.2022.2062347

Verify or expand the search:

Other recruiting trials for Multiple Myeloma

Currently open trials in the same condition.

NCT07200102 — Selinexor Maintenance Post CAR-T Cell Therapy for Multiple Myeloma · Phase 1 · recruiting
NCT07340853 — CRISPR Delivered Anti-BCMA Car-T Therapy for Relapsed or Refractory Multiple Myeloma · Phase 1 · recruiting
NCT07454382 — A Study of Elranatamab and Cyclophosphamide in People With Multiple Myeloma · Phase 2 · recruiting
NCT07266441 — A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma · Phase 2 · recruiting
NCT07258511 — A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With · Phase 3 · recruiting

Other Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH trials

Trials by the same sponsor.

NCT02335268 — Validation of a Predictive Model of Response to Romiplostim in Patients With IPSS Low or Intermediate-1 Risk MDS and Thr · Phase 2 · completed
NCT03622931 — Patients With Relapsed Ovarian Cancer (2nd and 3rd Line) Treated With Chemotherapy According to AGO Guidelines · Phase 2 · terminated
NCT01509560 — PhaseII,Open-label,Pilot Study Evaluating the Safety+Efficacy of Certican ® in the Prevention of Chronic Graft-versus-ho · Phase 2 · completed
NCT01320111 — Breast Cancer Study: Paclitaxel Versus Paclitaxel Plus Sorafenib in Second- or Third-line Treatment · Phase 2 · completed
NCT01081431 — Safety of Lenalidomide and Markers for Disease Progression in Patients With International Prognostic Scoring System (IPS · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01090089 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH
Last refreshed: 23 February 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01090089.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing