Last reviewed · How we verify
NCT01731886
A Randomized Clinical Trial of Lenalidomide (CC-5013) and Dexamethasone With and Without Autologous Peripheral Blood Stem Cell Transplant in Patients With Newly Diagnosed Multiple Myeloma
Phase 4 trial testing Autologous peripheral blood stem cell transplant in Multiple Myeloma in 60 participants. Completed in 11 April 2017.
11 April 2017
Quick facts
| Lead sponsor | Columbia University |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 1 September 2012 |
| Primary completion | 11 April 2017 |
| Estimated completion | 11 April 2017 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Autologous peripheral blood stem cell transplant
- Lenalidomide — full drug profile →
- Dexamethasone (dexamethasone) — full drug profile →
- Stem cell collection
- Melphalan
- G-CSF
- Cyclophosphamide (cyclophosphamide) — full drug profile →
- Mesna (MESNA) — full drug profile →
Conditions studied
- Multiple Myeloma — all drugs for Multiple Myeloma →
Sponsor
Columbia 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.
-
Complete Response Rate
Time frame: 3 years
The primary objective of this study is to determine the complete response rate of lenalidomide and low-dose dexamethasone versus that of lenalidomide and low-dose dexamethasone followed by autologous peripheral blood stem cell transplant in patients with newly diagnosed multiple myeloma (will include unconfirmed complete response (CR), CR and stringent complete response (sCR)).
Sponsor's own description
The study is being done to compare the combination of lenalidomide and dexamethasone followed by autologous peripheral blood stem cell transplant (PBSCT) and lenalidomide and dexamethasone without PBSCT in patients with untreated multiple myeloma. This comparison will include how the subjects respond to each study treatment combination, and what side effects are caused by each combination.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Tumor biomarkers for diagnosis, prognosis and targeted therapy.
Zhou Y, Tao L, Qiu J, Xu J, et al · · 2024 · cited 379× · PMID 38763973 · DOI 10.1038/s41392-024-01823-2 -
Nanomaterials for Antiangiogenic Therapies for Cancer: A Promising Tool for Personalized Medicine.
Alsaab HO, Al-Hibs AS, Alzhrani R, Alrabighi KK, et al · · 2021 · cited 32× · PMID 33562829 · DOI 10.3390/ijms22041631
Verify or expand the search:
- PubMed search for NCT01731886
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Autologous peripheral blood stem cell transplant
Trials testing the same drug.
- NCT04687098 — Risk-adapted Therapy for Primary Acute Myeloid Leukemia · Phase 2 · completed
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 Columbia University trials
Trials by the same sponsor.
- NCT06558422 — Human Models of Selective Insulin Resistance: Pancreatic Clamp · Phase 1 · not yet recruiting
- NCT07264582 — HIV/STI/HCV Testing and Overdose Prevention Among Survivors of Sex Trafficking · NA · not yet recruiting
- NCT05992415 — Know Your Pressures NYC · NA · not yet recruiting
- NCT05645211 — The AgRP and GH/IGF-1 Axis in Children · not yet recruiting
- NCT07403604 — Effect of Insulin Lowering on Lipogenesis · Phase 1 · 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 NCT01731886 (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 Columbia University
- Last refreshed: 21 January 2020
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/NCT01731886.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing