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NCT01054196
Lenalidomide Plus Melphalan as a Preparative Regimen for Autologous Stem Cell Transplantation in Relapsed Multiple Myeloma: A Phase 1 / 2 Study
Phase 1/Phase 2 trial testing lenalidomide in Multiple Myeloma in 52 participants. Participants enrolled and being followed up; not accepting new ones.
1 October 2021
Quick facts
| Lead sponsor | Weill Medical College of Cornell University |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 52 |
| Start date | 1 August 2010 |
| Primary completion | 1 October 2021 |
| Estimated completion | 1 December 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- lenalidomide — full drug profile →
- melphalan (melphalan) — full drug profile →
Conditions studied
- Multiple Myeloma — all drugs for Multiple Myeloma →
Sponsor
Weill Medical College of Cornell University
Who can join
18 and older, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Maximum Tolerated Dose (MTD) of Lenalidomide That Can be Added to Melphalan
Time frame: 12 months
The primary endpoint for the phase 1 portion of this study is to determine the maximum tolerated dose of lenalidomide that can be added to melphalan. -
Duration of Overall Response (DoR)
Time frame: Until disease progression, death, or for a maximum of 3 years, whichever occurs first
The primary endpoint for the phase 2 portion of this study is to determine the duration of overall response (DoR). The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurement
Sponsor's own description
A) Phase 1: To determine the maximal tolerated dose (MTD) of lenalidomide that can be safely added to high-dose melphalan prior to autologous stem cell transplantation (ASCT). B) Phase 2: To determine whether the addition of high-dose lenalidomide to ASCT followed by maintenance standard-dose lenalidomide improves the response rate and duration of response for relapsed multiple myeloma (RMM).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT01054196
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of lenalidomide
Trials testing the same drug.
- NCT05776979 — Post-Transplant Maintenance Therapy With Isatuximab Plus Lenalidomide for High-Risk Multiple Myeloma Patients · Phase 2 · recruiting
- NCT05867030 — Parsaclisib in Patients With Relapsed or Refractory Follicular Lymphoma · Phase 1 · withdrawn
- NCT07184424 — Real-world Study of Lenalidomide After First-line Treatment Lenvatinib With PD-1 in Advanced HCC · NA · completed
- NCT05846750 — Obinutuzumab in Combination With Lenalidomide in Relapsed or Refractory Marginal Zone Lymphoma · Phase 2 · recruiting
- NCT05260619 — Lenalidomide Maintenance Treatment in Patients With Primary Central Nervous System Lymphoma · Phase 2 · recruiting
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 Weill Medical College of Cornell University trials
Trials by the same sponsor.
- NCT07485712 — Center for Research and Education on Aging and Technology Enhancement - CREATE V - Project 2 · NA · not yet recruiting
- NCT05811338 — Center for Research and Education on Aging and Technology Enhancement - CREATE V - Project 1 · NA · not yet recruiting
- NCT06118983 — Improving TRansitions ANd OutcomeS for Heart FailurE Patients in Home Health CaRe (I-TRANSFER-HF) · NA · recruiting
- NCT06818734 — Implementation of a Clinical Decision Support Tool for Postpartum Depression · NA · not yet recruiting
- NCT07485725 — Center for Research and Education on Aging and Technology Enhancement - CREATE V - Project 3 · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01054196 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Weill Medical College of Cornell University
- Last refreshed: 26 March 2026
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/NCT01054196.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing